Trial Outcomes & Findings for Study of CB-839 (Telaglenastat) in Combination With Talazoparib in Patients With Solid Tumors (NCT NCT03875313)
NCT ID: NCT03875313
Last Updated: 2022-02-17
Results Overview
AEs were grades as assessed by CTCAE v 5.0. A TEAE is defined as any AE occurring on or after the first dose of study drug, or existing events that worsened after the first dose during the study, up to 28 days after the last dose. An AE is considered "related" if the investigator assessed the relationship as "possibly related" or "probably related." Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression. Grade 5 disease progression events are excluded from this table.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Results posted on
2022-02-17
Participant Flow
Participant milestones
| Measure |
600 mg CB-839 + 1 mg Talazoparib
600 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with advanced or metastatic solid tumors.
|
800 mg CB-839 + 1 mg Talazoparib: ccRCC
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) who received ≥ 2 prior systemic regimens including ≥ 1 vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR TKI) therapy.
|
800 mg CB-839 + 1 mg Talazoparib: TNBC
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic triple-negative breast cancer (TNBC) estrogen receptor (ER)-, progesterone receptor (PR)-, and human epidermal growth factor receptor 2 (HER2)-negativewho received ≥ 1 prior line of cytotoxic chemotherapy with no prior poly adenosine diphosphate ribose polymerase (PARP) inhibitor therapy for TNBC or platinum-based chemotherapy for metastatic TNBC.
|
800 mg CB-839 + 1 mg Talazoparib: CRC
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with with incurable/locally advanced or metastatic colorectal cancer (CRC) who received appropriate oxaliplatin or irinotecan- and fluorouracil (5-FU)-based chemotherapy with or without bevacizumab.
|
800 mg CB-839 + 1 mg Talazoparib: Other Histology
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with other tumor types (prostate, urinary bladder, pancreas, and stomach).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
16
|
6
|
4
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
16
|
6
|
4
|
4
|
Reasons for withdrawal
| Measure |
600 mg CB-839 + 1 mg Talazoparib
600 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with advanced or metastatic solid tumors.
|
800 mg CB-839 + 1 mg Talazoparib: ccRCC
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) who received ≥ 2 prior systemic regimens including ≥ 1 vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR TKI) therapy.
|
800 mg CB-839 + 1 mg Talazoparib: TNBC
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic triple-negative breast cancer (TNBC) estrogen receptor (ER)-, progesterone receptor (PR)-, and human epidermal growth factor receptor 2 (HER2)-negativewho received ≥ 1 prior line of cytotoxic chemotherapy with no prior poly adenosine diphosphate ribose polymerase (PARP) inhibitor therapy for TNBC or platinum-based chemotherapy for metastatic TNBC.
|
800 mg CB-839 + 1 mg Talazoparib: CRC
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with with incurable/locally advanced or metastatic colorectal cancer (CRC) who received appropriate oxaliplatin or irinotecan- and fluorouracil (5-FU)-based chemotherapy with or without bevacizumab.
|
800 mg CB-839 + 1 mg Talazoparib: Other Histology
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with other tumor types (prostate, urinary bladder, pancreas, and stomach).
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Study Termination by Sponsor
|
0
|
1
|
1
|
0
|
1
|
|
Overall Study
New Anticancer Treatment
|
0
|
1
|
2
|
1
|
0
|
|
Overall Study
Other, Not Specified
|
2
|
11
|
3
|
3
|
1
|
Baseline Characteristics
Study of CB-839 (Telaglenastat) in Combination With Talazoparib in Patients With Solid Tumors
Baseline characteristics by cohort
| Measure |
600 mg CB-839 + 1 mg Talazoparib
n=3 Participants
600 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with advanced or metastatic solid tumors.
|
800 mg CB-839 + 1 mg Talazoparib: ccRCC
n=16 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic ccRCC who received ≥ 2 prior systemic regimens including ≥ 1 VEGFR TKI therapy.
|
800 mg CB-839 + 1 mg Talazoparib: TNBC
n=6 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic TNBC ER-, PR-, and HER2-negative who received ≥ 1 prior line of cytotoxic chemotherapy with no prior PARP inhibitor therapy for TNBC or platinum-based chemotherapy for metastatic TNBC.
|
800 mg CB-839 + 1 mg Talazoparib: CRC
n=4 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with with incurable/locally advanced or metastatic CRC who received appropriate oxaliplatin or irinotecan- and 5-FU-based chemotherapy with or without bevacizumab.
|
800 mg CB-839 + 1 mg Talazoparib: Other Histology
n=4 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with other tumor types (prostate, urinary bladder, pancreas, and stomach).
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 10.00 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 10.58 • n=7 Participants
|
51.3 years
STANDARD_DEVIATION 13.19 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 10.66 • n=4 Participants
|
59.0 years
STANDARD_DEVIATION 11.69 • n=21 Participants
|
58.5 years
STANDARD_DEVIATION 11.21 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other, Not Specified
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.Population: Safety Analysis Set: all participants who received at least 1 dose of any study-specific treatment (telaglenastat or talazoparib).
AEs were grades as assessed by CTCAE v 5.0. A TEAE is defined as any AE occurring on or after the first dose of study drug, or existing events that worsened after the first dose during the study, up to 28 days after the last dose. An AE is considered "related" if the investigator assessed the relationship as "possibly related" or "probably related." Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression. Grade 5 disease progression events are excluded from this table.
Outcome measures
| Measure |
600 mg CB-839 + 1 mg Talazoparib
n=3 Participants
600 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with advanced or metastatic solid tumors.
|
800 mg CB-839 + 1 mg Talazoparib: ccRCC
n=16 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic ccRCC who received ≥ 2 prior systemic regimens including ≥ 1 VEGFR TKI therapy.
|
800 mg CB-839 + 1 mg Talazoparib: TNBC
n=6 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic TNBC ER-, PR-, and HER2-negative who received ≥ 1 prior line of cytotoxic chemotherapy with no prior PARP inhibitor therapy for TNBC or platinum-based chemotherapy for metastatic TNBC.
|
800 mg CB-839 + 1 mg Talazoparib: CRC
n=4 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with with incurable/locally advanced or metastatic CRC who received appropriate oxaliplatin or irinotecan- and 5-FU-based chemotherapy with or without bevacizumab.
|
800 mg CB-839 + 1 mg Talazoparib: Other Histology
n=4 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with other tumor types (prostate, urinary bladder, pancreas, and stomach).
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
SAE with CTCAE grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
AE
|
3 Participants
|
16 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
AE grade ≥ 3
|
1 Participants
|
12 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
AE related to telaglenastat
|
3 Participants
|
14 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
AE related to talazoparib
|
3 Participants
|
16 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
AE related to telaglenastat and talazoparib
|
3 Participants
|
11 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
AE grade ≥ 3 related to telaglenastat
|
1 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
AE grade ≥ 3 related to talazoparib
|
1 Participants
|
11 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
AE leading to discontinuation of telaglenastat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
AE leading to discontinuation of talazoparib
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
AE leading to discontinuation of telaglenastat and talazoparib
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
AE leading to discontinuation of telaglenastat or talazoparib
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
AE leading to telaglenastat dose interruption or reduction
|
0 Participants
|
10 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
AE leading to talazoparib dose interruption or reduction
|
1 Participants
|
12 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
AE leading to telaglenastat and talazoparib dose interruption or reduction
|
0 Participants
|
9 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
AE leading to telaglenastat or talazoparib dose interruption or reduction
|
1 Participants
|
12 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
SAE with CTCAE grade 5 related to telaglenastat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
SAE with CTCAE grade 5 related to talazoparib
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
SAE
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
SAE grade ≥ 3
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
SAE related to telaglenastat
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Excluding Deaths Due to Disease Progression
SAE related to talazoparib
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Hematology: screening, cycle 1 day 1, cycle 1 day 15, cycle 2 day 1, end of treatment (EOT). Clinical chemistry parameters: screening, cycle 1 day 1, cycle 1 day 8, cycle 1 day 15, cycle 1 day 22, cycle 2 day 1, cycle 2 day 15, EOT.Population: Safety Analysis Set: all participants who received at least 1 dose of any study-specific treatment (telaglenastat or talazoparib).
Hematology parameters conducted included red blood cell (RBC) count, hematocrit, hemoglobin, mean corpuscular volume (MCV), platelet count, white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils, and basophils, performed at the discretion of the investigator. Clinical chemistry parameters included aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin, direct bilirubin, albumin, total protein, blood urea nitrogen (BUN), creatinine, sodium, potassium, chloride, calcium, carbon dioxide, glucose, and lactate dehydrogenase (LDH), performed at the discretion of the investigator.
Outcome measures
| Measure |
600 mg CB-839 + 1 mg Talazoparib
n=3 Participants
600 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with advanced or metastatic solid tumors.
|
800 mg CB-839 + 1 mg Talazoparib: ccRCC
n=16 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic ccRCC who received ≥ 2 prior systemic regimens including ≥ 1 VEGFR TKI therapy.
|
800 mg CB-839 + 1 mg Talazoparib: TNBC
n=6 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic TNBC ER-, PR-, and HER2-negative who received ≥ 1 prior line of cytotoxic chemotherapy with no prior PARP inhibitor therapy for TNBC or platinum-based chemotherapy for metastatic TNBC.
|
800 mg CB-839 + 1 mg Talazoparib: CRC
n=4 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with with incurable/locally advanced or metastatic CRC who received appropriate oxaliplatin or irinotecan- and 5-FU-based chemotherapy with or without bevacizumab.
|
800 mg CB-839 + 1 mg Talazoparib: Other Histology
n=4 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with other tumor types (prostate, urinary bladder, pancreas, and stomach).
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities (Hematology, Clinical Chemistry) at More Than 1 Clinic Visit
Hematology
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (Hematology, Clinical Chemistry) at More Than 1 Clinic Visit
Clinical Chemistry
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During Cycle 1 on Days 1 through 28, inclusivePopulation: DLT Evaluable Participants: All participants were considered DLT-evaluable, with the following exceptions: participants who withdrew or were withdrawn from the study prior to completing the DLT assessment window for any reason other than a DLT; participants who did not receive ≥ 75% of the assigned dose (depending on dose level) of telaglenastat and talazoparib, i.e., 42 doses of telaglenastat and 21 doses of talazoparib, in the first 28-day treatment cycle for any reason other than a DLT.
A DLT was defined as an AE determined by the investigator to be possibly or probably related to study drug that also was: * Any ≥ Grade (Gr) 4 non-hematological toxicity * Gr 3 non-hematologic toxicity, except: fatigue; nausea/vomiting that responds within 24 hours after initiating maximal supportive care; rash or itching that resolves to ≤ Gr 1 within 2 weeks. * Any clinically meaningful Gr 3 non-hematologic laboratory value if medical intervention is required OR the abnormality leads to hospitalization, OR the abnormality persists for \> 1 week (except Gr 3/4 elevation in serum amylase and/or lipase not associated with clinical or radiological evidence of pancreatitis). * Gr ≥ 3 febrile neutropenia * Gr ≥ 4 anemia; neutropenia lasting \> 7 days; thrombocytopenia * Gr 3 thrombocytopenia associated with: a bleeding event that requires a platelet transfusion OR a life-threatening bleeding event occurring due to low platelet count which results in urgent intervention.
Outcome measures
| Measure |
600 mg CB-839 + 1 mg Talazoparib
n=3 Participants
600 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with advanced or metastatic solid tumors.
|
800 mg CB-839 + 1 mg Talazoparib: ccRCC
n=16 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic ccRCC who received ≥ 2 prior systemic regimens including ≥ 1 VEGFR TKI therapy.
|
800 mg CB-839 + 1 mg Talazoparib: TNBC
n=6 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic TNBC ER-, PR-, and HER2-negative who received ≥ 1 prior line of cytotoxic chemotherapy with no prior PARP inhibitor therapy for TNBC or platinum-based chemotherapy for metastatic TNBC.
|
800 mg CB-839 + 1 mg Talazoparib: CRC
n=4 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with with incurable/locally advanced or metastatic CRC who received appropriate oxaliplatin or irinotecan- and 5-FU-based chemotherapy with or without bevacizumab.
|
800 mg CB-839 + 1 mg Talazoparib: Other Histology
n=4 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with other tumor types (prostate, urinary bladder, pancreas, and stomach).
|
|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Maximum duration of follow-up for ORR was 12.9 months.Population: Efficacy Evaluable Population: all participants who had measurable disease at baseline, received at least one dose of study drug (telaglenastat or talazoparib), and completed at least one post-baseline tumor assessment, or discontinued study treatment early due to study drug-related toxicity or for disease-related death.
ORR was defined by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 as the percentage of participants with documented complete response (CR) or partial response (PR) since the date of treatment initiation. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease must have been a minimum of 51 days from date of treatment initiation. Exact binomial confidence intervals (Clopper Pearson).
Outcome measures
| Measure |
600 mg CB-839 + 1 mg Talazoparib
n=2 Participants
600 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with advanced or metastatic solid tumors.
|
800 mg CB-839 + 1 mg Talazoparib: ccRCC
n=15 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic ccRCC who received ≥ 2 prior systemic regimens including ≥ 1 VEGFR TKI therapy.
|
800 mg CB-839 + 1 mg Talazoparib: TNBC
n=5 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic TNBC ER-, PR-, and HER2-negative who received ≥ 1 prior line of cytotoxic chemotherapy with no prior PARP inhibitor therapy for TNBC or platinum-based chemotherapy for metastatic TNBC.
|
800 mg CB-839 + 1 mg Talazoparib: CRC
n=4 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with with incurable/locally advanced or metastatic CRC who received appropriate oxaliplatin or irinotecan- and 5-FU-based chemotherapy with or without bevacizumab.
|
800 mg CB-839 + 1 mg Talazoparib: Other Histology
n=3 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with other tumor types (prostate, urinary bladder, pancreas, and stomach).
|
|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
0.0 percentage of participants
Interval 0.0 to 21.8
|
0.0 percentage of participants
Interval 0.0 to 52.2
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
PRIMARY outcome
Timeframe: Maximum duration of follow-up for cORR was 12.9 months.Population: Efficacy Evaluable Population: all participants who had measurable disease at baseline, received at least one dose of study drug (telaglenastat or talazoparib), and completed at least one post-baseline tumor assessment, or discontinued study treatment early due to study drug-related toxicity or for disease-related death.
Overall Response Rate is defined by RECIST v1.1 as the percentage of participants with documented confirmed CR or confirmed PR since the date of treatment initiation. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR or PR must have been sustained a minimum of 28 days when confirmation was reported. Stable disease must have been a minimum of 51 days from date of treatment initiation. Exact binomial confidence intervals (Clopper Pearson).
Outcome measures
| Measure |
600 mg CB-839 + 1 mg Talazoparib
n=2 Participants
600 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with advanced or metastatic solid tumors.
|
800 mg CB-839 + 1 mg Talazoparib: ccRCC
n=15 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic ccRCC who received ≥ 2 prior systemic regimens including ≥ 1 VEGFR TKI therapy.
|
800 mg CB-839 + 1 mg Talazoparib: TNBC
n=5 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic TNBC ER-, PR-, and HER2-negative who received ≥ 1 prior line of cytotoxic chemotherapy with no prior PARP inhibitor therapy for TNBC or platinum-based chemotherapy for metastatic TNBC.
|
800 mg CB-839 + 1 mg Talazoparib: CRC
n=4 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with with incurable/locally advanced or metastatic CRC who received appropriate oxaliplatin or irinotecan- and 5-FU-based chemotherapy with or without bevacizumab.
|
800 mg CB-839 + 1 mg Talazoparib: Other Histology
n=3 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with other tumor types (prostate, urinary bladder, pancreas, and stomach).
|
|---|---|---|---|---|---|
|
Confirmed ORR (cORR)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
0.0 percentage of participants
Interval 0.0 to 21.8
|
0.0 percentage of participants
Interval 0.0 to 52.2
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
PRIMARY outcome
Timeframe: Maximum duration of follow-up for CBR was 12.9 months.Population: Efficacy Evaluable Population: all participants who had measurable disease at baseline, received at least one dose of study drug (telaglenastat or talazoparib), and completed at least one post-baseline tumor assessment, or discontinued study treatment early due to study drug-related toxicity or for disease-related death.
Clinical Benefit Rate is defined by RECIST v1.1 as the percentage of participants with documented CR, PR, or stable disease (SD) since the date of treatment initiation. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR or PR must have been sustained a minimum of 28 days when confirmation was reported. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. SD must have been a minimum of 102 days from date of treatment initiation and documented on at least 2 consecutive post-baseline scans. Exact binomial confidence intervals (Clopper Pearson).
Outcome measures
| Measure |
600 mg CB-839 + 1 mg Talazoparib
n=2 Participants
600 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with advanced or metastatic solid tumors.
|
800 mg CB-839 + 1 mg Talazoparib: ccRCC
n=15 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic ccRCC who received ≥ 2 prior systemic regimens including ≥ 1 VEGFR TKI therapy.
|
800 mg CB-839 + 1 mg Talazoparib: TNBC
n=5 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic TNBC ER-, PR-, and HER2-negative who received ≥ 1 prior line of cytotoxic chemotherapy with no prior PARP inhibitor therapy for TNBC or platinum-based chemotherapy for metastatic TNBC.
|
800 mg CB-839 + 1 mg Talazoparib: CRC
n=4 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with with incurable/locally advanced or metastatic CRC who received appropriate oxaliplatin or irinotecan- and 5-FU-based chemotherapy with or without bevacizumab.
|
800 mg CB-839 + 1 mg Talazoparib: Other Histology
n=3 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with other tumor types (prostate, urinary bladder, pancreas, and stomach).
|
|---|---|---|---|---|---|
|
Clinical Benefit Rate (CBR)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
20.0 percentage of participants
Interval 4.3 to 48.1
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
PRIMARY outcome
Timeframe: Maximum duration of follow-up for PFS was 12.9 months.Population: Efficacy Evaluable Population: all participants who had measurable disease at baseline, received at least one dose of study drug (telaglenastat or talazoparib), and completed at least one post-baseline tumor assessment, or discontinued study treatment early due to study drug-related toxicity or for disease-related death.
PFS was defined as the time from treatment initiation to the date of documented disease progression (PD) within 2 consecutive scheduled radiographic disease assessments or death for any cause, whichever occurs first. PD: ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of ≥ 5 mm. (The appearance of one or more new lesions is also considered progression). Participants with no documentation of PD or death on-study, PD or death occurs after missing 2 consecutive scheduled radiographic disease assessments, or new anti-cancer therapy were censored at the date of last available tumor assessment. Participants missing baseline disease assessments were censored at the date of first dose. Kaplan-Meier product-limit estimates. Brookmeyer-Crowley methodology for a non-parametric 95% CI was used.
Outcome measures
| Measure |
600 mg CB-839 + 1 mg Talazoparib
n=2 Participants
600 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with advanced or metastatic solid tumors.
|
800 mg CB-839 + 1 mg Talazoparib: ccRCC
n=15 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic ccRCC who received ≥ 2 prior systemic regimens including ≥ 1 VEGFR TKI therapy.
|
800 mg CB-839 + 1 mg Talazoparib: TNBC
n=5 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic TNBC ER-, PR-, and HER2-negative who received ≥ 1 prior line of cytotoxic chemotherapy with no prior PARP inhibitor therapy for TNBC or platinum-based chemotherapy for metastatic TNBC.
|
800 mg CB-839 + 1 mg Talazoparib: CRC
n=4 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with with incurable/locally advanced or metastatic CRC who received appropriate oxaliplatin or irinotecan- and 5-FU-based chemotherapy with or without bevacizumab.
|
800 mg CB-839 + 1 mg Talazoparib: Other Histology
n=3 Participants
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with other tumor types (prostate, urinary bladder, pancreas, and stomach).
|
|---|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
1.86 months
Interval 1.84 to 1.87
|
1.87 months
Interval 1.77 to 3.88
|
1.71 months
Interval 1.18 to 3.71
|
1.66 months
Interval 0.1 to 1.84
|
NA months
Interval 0.92 to
insufficient number of participants with events
|
Adverse Events
600 mg CB-839 + 1 mg Talazoparib
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
800 mg CB-839 + 1 mg Talazoparib: ccRCC
Serious events: 2 serious events
Other events: 16 other events
Deaths: 1 deaths
800 mg CB-839 + 1 mg Talazoparib: TNBC
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
800 mg CB-839 + 1 mg Talazoparib: CRC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
800 mg CB-839 + 1 mg Talazoparib: Other Histology
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
600 mg CB-839 + 1 mg Talazoparib
n=3 participants at risk
600 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with advanced or metastatic solid tumors.
|
800 mg CB-839 + 1 mg Talazoparib: ccRCC
n=16 participants at risk
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic ccRCC who received ≥ 2 prior systemic regimens including ≥ 1 VEGFR TKI therapy.
|
800 mg CB-839 + 1 mg Talazoparib: TNBC
n=6 participants at risk
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic TNBC ER-, PR-, and HER2-negative who received ≥ 1 prior line of cytotoxic chemotherapy with no prior PARP inhibitor therapy for TNBC or platinum-based chemotherapy for metastatic TNBC.
|
800 mg CB-839 + 1 mg Talazoparib: CRC
n=4 participants at risk
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with with incurable/locally advanced or metastatic CRC who received appropriate oxaliplatin or irinotecan- and 5-FU-based chemotherapy with or without bevacizumab.
|
800 mg CB-839 + 1 mg Talazoparib: Other Histology
n=4 participants at risk
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with other tumor types (prostate, urinary bladder, pancreas, and stomach).
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
12.5%
2/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
General disorders
Pain
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor associated fever
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
Other adverse events
| Measure |
600 mg CB-839 + 1 mg Talazoparib
n=3 participants at risk
600 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with advanced or metastatic solid tumors.
|
800 mg CB-839 + 1 mg Talazoparib: ccRCC
n=16 participants at risk
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic ccRCC who received ≥ 2 prior systemic regimens including ≥ 1 VEGFR TKI therapy.
|
800 mg CB-839 + 1 mg Talazoparib: TNBC
n=6 participants at risk
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with incurable/locally advanced or metastatic TNBC ER-, PR-, and HER2-negative who received ≥ 1 prior line of cytotoxic chemotherapy with no prior PARP inhibitor therapy for TNBC or platinum-based chemotherapy for metastatic TNBC.
|
800 mg CB-839 + 1 mg Talazoparib: CRC
n=4 participants at risk
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with with incurable/locally advanced or metastatic CRC who received appropriate oxaliplatin or irinotecan- and 5-FU-based chemotherapy with or without bevacizumab.
|
800 mg CB-839 + 1 mg Talazoparib: Other Histology
n=4 participants at risk
800 mg CB-839 taken twice daily and 1 mg talazoparib taken once daily in participants with other tumor types (prostate, urinary bladder, pancreas, and stomach).
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
43.8%
7/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
66.7%
4/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
50.0%
2/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
37.5%
6/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
50.0%
2/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
12.5%
2/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
18.8%
3/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Gastrointestinal disorders
Dyspepsia
|
66.7%
2/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
68.8%
11/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
50.0%
3/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
50.0%
2/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
18.8%
3/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
50.0%
2/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
General disorders
Chills
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
General disorders
Face oedema
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
62.5%
10/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
33.3%
2/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
50.0%
2/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
37.5%
6/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
4/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
33.3%
2/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
50.0%
2/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
4/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
18.8%
3/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
12.5%
2/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
12.5%
2/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
33.3%
2/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Investigations
Liver function test increased
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
31.2%
5/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
31.2%
5/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
50.0%
2/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
18.8%
3/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
12.5%
2/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Musculoskeletal and connective tissue disorders
Hypophosphataemia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
12.5%
2/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
18.8%
3/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
12.5%
2/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
4/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
12.5%
2/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Musculoskeletal and connective tissue disorders
Foot fracture
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
12.5%
2/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
12.5%
2/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Eye disorders
Photophobia
|
33.3%
1/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
33.3%
2/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
50.0%
2/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
18.8%
3/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
33.3%
2/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
4/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
33.3%
1/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
16.7%
1/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
25.0%
1/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
|
Reproductive system and breast disorders
Uterine mass
|
0.00%
0/3 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
6.2%
1/16 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/6 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
0.00%
0/4 • Start of treatment to 28 days post treatment; mean overall duration of talazoparib exposure was 88.7 days.
Per protocol, the serious and nonserious adverse event tables exclude grade 5 disease progression events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No publication by the PI before either a multi-site publication or 18 months after final multi-site study report. PI can only publish their own results and provide 45 days in advance notice. PI must delete any Calithera confidential information from the publication other than study results and give good faith consideration to other comments made by Calithera. The PI must delay the publication for up to 45 days if requested by Calithera and publicly acknowledge Calithera and Pfizer support.
- Publication restrictions are in place
Restriction type: OTHER