Trial Outcomes & Findings for ABT-888 and Temozolomide for Metastatic Breast Cancer and BRCA1/2 Breast Cancer (NCT NCT01009788)
NCT ID: NCT01009788
Last Updated: 2025-03-14
Results Overview
Objective response rate (ORR) is defined as the percentage of enrolled patients who have a partial or complete response per RECIST (Response Evaluation Criteria in Solid Tumors) v1.1 guidelines. A partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. A complete response is defined as disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) reduced in short axis to \<10 mm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
2 years
Results posted on
2025-03-14
Participant Flow
Participant milestones
| Measure |
TMZ/ABT888 Primary Cohort
Primary cohort included patients unselected for BRCA1/2 mutations or breast cancer subtype.
Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30-40 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated
ABT-888: Capsules (30-40 mg) taken orally twice a day on days 1-7 of each 28 day cycle
temozolomide: Capsules (150 mg/m\^2 initially, and 200 mg/m\^2 starting cycle 2 if tolerated) taken orally once a day on days 1 through 5 of a 28 day cycle
|
TMZ/ABT888 Expansion Cohort
Expansion cohort included patients with BRCA1/2 deleterious mutations.
Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated
ABT-888: Capsules (30-40 mg) taken orally twice a day on days 1-7 of each 28 day cycle
temozolomide: Capsules (150 mg/m\^2 initially, and 200 mg/m\^2 starting cycle 2 if tolerated) taken orally once a day on days 1 through 5 of a 28 day cycle
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
21
|
|
Overall Study
COMPLETED
|
41
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
TMZ/ABT888 Primary Cohort
Primary cohort included patients unselected for BRCA1/2 mutations or breast cancer subtype.
Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30-40 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated
ABT-888: Capsules (30-40 mg) taken orally twice a day on days 1-7 of each 28 day cycle
temozolomide: Capsules (150 mg/m\^2 initially, and 200 mg/m\^2 starting cycle 2 if tolerated) taken orally once a day on days 1 through 5 of a 28 day cycle
|
TMZ/ABT888 Expansion Cohort
Expansion cohort included patients with BRCA1/2 deleterious mutations.
Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated
ABT-888: Capsules (30-40 mg) taken orally twice a day on days 1-7 of each 28 day cycle
temozolomide: Capsules (150 mg/m\^2 initially, and 200 mg/m\^2 starting cycle 2 if tolerated) taken orally once a day on days 1 through 5 of a 28 day cycle
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
ABT-888 and Temozolomide for Metastatic Breast Cancer and BRCA1/2 Breast Cancer
Baseline characteristics by cohort
| Measure |
TMZ/ABT888 Primary Cohort
n=41 Participants
Primary cohort included patients unselected for BRCA1/2 mutations or breast cancer subtype.
Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30-40 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated
ABT-888: Capsules (30-40 mg) taken orally twice a day on days 1-7 of each 28 day cycle
temozolomide: Capsules (150 mg/m\^2 initially, and 200 mg/m\^2 starting cycle 2 if tolerated) taken orally once a day on days 1 through 5 of a 28 day cycle
|
TMZ/ABT888 Expansion Cohort
n=21 Participants
Expansion cohort included patients with BRCA1/2 deleterious mutations.
Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated
ABT-888: Capsules (30-40 mg) taken orally twice a day on days 1-7 of each 28 day cycle
temozolomide: Capsules (150 mg/m\^2 initially, and 200 mg/m\^2 starting cycle 2 if tolerated) taken orally once a day on days 1 through 5 of a 28 day cycle
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
46 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: For the primary cohort, 7 patients were not evaluable out of the original 41 because they had no follow up imaging due to rapid clinical progression. For the expansion cohort, 3 patients were not evaluable out of the original 21 because they had no follow up imaging due to rapid clinical progression.
Objective response rate (ORR) is defined as the percentage of enrolled patients who have a partial or complete response per RECIST (Response Evaluation Criteria in Solid Tumors) v1.1 guidelines. A partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. A complete response is defined as disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) reduced in short axis to \<10 mm.
Outcome measures
| Measure |
TMZ/ABT888 Primary Cohort
n=34 Participants
Primary cohort included patients unselected for BRCA1/2 mutations or breast cancer subtype.
Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30-40 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated
ABT-888: Capsules (30-40 mg) taken orally twice a day on days 1-7 of each 28 day cycle
temozolomide: Capsules (150 mg/m\^2 initially, and 200 mg/m\^2 starting cycle 2 if tolerated) taken orally once a day on days 1 through 5 of a 28 day cycle
|
TMZ/ABT888 Expansion Cohort
n=18 Participants
Expansion cohort included patients with BRCA1/2 deleterious mutations.
Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated
ABT-888: Capsules (30-40 mg) taken orally twice a day on days 1-7 of each 28 day cycle
temozolomide: Capsules (150 mg/m\^2 initially, and 200 mg/m\^2 starting cycle 2 if tolerated) taken orally once a day on days 1 through 5 of a 28 day cycle
|
|---|---|---|
|
Objective Response Rate (ORR) of ABT-888 and Temozolomide (TMZ) in Metastatic Breast Cancer
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 5 yearsProgression free survival is defined as the length of time from enrollment until disease progression, death, or date of last patient contact. Progressive disease was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease is defined as at least a 20% increase (at least 5 mm) in the sum of the LD of target lesions in comparison with the lowest sum achieved on study or the appearance of one or more new lesions, and/or unequivocal progression of non-target lesions.
Outcome measures
| Measure |
TMZ/ABT888 Primary Cohort
n=41 Participants
Primary cohort included patients unselected for BRCA1/2 mutations or breast cancer subtype.
Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30-40 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated
ABT-888: Capsules (30-40 mg) taken orally twice a day on days 1-7 of each 28 day cycle
temozolomide: Capsules (150 mg/m\^2 initially, and 200 mg/m\^2 starting cycle 2 if tolerated) taken orally once a day on days 1 through 5 of a 28 day cycle
|
TMZ/ABT888 Expansion Cohort
n=21 Participants
Expansion cohort included patients with BRCA1/2 deleterious mutations.
Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated
ABT-888: Capsules (30-40 mg) taken orally twice a day on days 1-7 of each 28 day cycle
temozolomide: Capsules (150 mg/m\^2 initially, and 200 mg/m\^2 starting cycle 2 if tolerated) taken orally once a day on days 1 through 5 of a 28 day cycle
|
|---|---|---|
|
Progression Free Survival
|
1.8 months
Interval 1.6 to 2.5
|
3.0 months
Interval 2.1 to 6.2
|
SECONDARY outcome
Timeframe: Four monthsClinical benefit rate (CBR) is defined as the percentage of patients who achieve a partial or complete response or stable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. A complete response is defined as disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) reduced in short axis to \<10 mm. Progressive disease is defined as at least a 20% increase (at least 5 mm) in the sum of the LD of target lesions in comparison with the lowest sum achieved on study or the appearance of one or more new lesions, and/or unequivocal progression of non-target lesions.
Outcome measures
| Measure |
TMZ/ABT888 Primary Cohort
n=41 Participants
Primary cohort included patients unselected for BRCA1/2 mutations or breast cancer subtype.
Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30-40 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated
ABT-888: Capsules (30-40 mg) taken orally twice a day on days 1-7 of each 28 day cycle
temozolomide: Capsules (150 mg/m\^2 initially, and 200 mg/m\^2 starting cycle 2 if tolerated) taken orally once a day on days 1 through 5 of a 28 day cycle
|
TMZ/ABT888 Expansion Cohort
n=21 Participants
Expansion cohort included patients with BRCA1/2 deleterious mutations.
Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated
ABT-888: Capsules (30-40 mg) taken orally twice a day on days 1-7 of each 28 day cycle
temozolomide: Capsules (150 mg/m\^2 initially, and 200 mg/m\^2 starting cycle 2 if tolerated) taken orally once a day on days 1 through 5 of a 28 day cycle
|
|---|---|---|
|
Clinical Benefit Rate
|
11 Participants
|
9 Participants
|
Adverse Events
TMZ/ABT888 Primary Cohort
Serious events: 25 serious events
Other events: 42 other events
Deaths: 36 deaths
TMZ/ABT888 Expansion Cohort
Serious events: 4 serious events
Other events: 21 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
TMZ/ABT888 Primary Cohort
n=42 participants at risk
Primary cohort included patients unselected for BRCA1/2 mutations or breast cancer subtype.
Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30-40 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated
ABT-888: Capsules (30-40 mg) taken orally twice a day on days 1-7 of each 28 day cycle
temozolomide: Capsules (150 mg/m\^2 initially, and 200 mg/m\^2 starting cycle 2 if tolerated) taken orally once a day on days 1 through 5 of a 28 day cycle
|
TMZ/ABT888 Expansion Cohort
n=21 participants at risk
Expansion cohort included patients with BRCA1/2 deleterious mutations.
Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated
ABT-888: Capsules (30-40 mg) taken orally twice a day on days 1-7 of each 28 day cycle
temozolomide: Capsules (150 mg/m\^2 initially, and 200 mg/m\^2 starting cycle 2 if tolerated) taken orally once a day on days 1 through 5 of a 28 day cycle
|
|---|---|---|
|
Investigations
Increased alkaline phosphatase
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Musculoskeletal and connective tissue disorders
arm pain
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Gastrointestinal disorders
ascites
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Gastrointestinal disorders
bowel perforation
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Gastrointestinal disorders
centralized abdominal pain
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
General disorders
chest pain
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
dehydration
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
disease progression
|
7.1%
3/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
3/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
General disorders
edema
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Gastrointestinal disorders
GI Hemorrhage
|
0.00%
0/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Blood and lymphatic system disorders
Hematocrit
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Reproductive system and breast disorders
hypoxia
|
4.8%
2/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Infections and infestations
Infection with unknown ANC, cerebrospinal fluid
|
0.00%
0/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Nervous system disorders
Leak, cerebrospinal fluid
|
0.00%
0/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Injury, poisoning and procedural complications
left distal femur fracture
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Musculoskeletal and connective tissue disorders
Left lower extremity weakness
|
0.00%
0/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Blood and lymphatic system disorders
low platelet count (thrombocytopenia)
|
9.5%
4/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Psychiatric disorders
mood alteration/anxiety
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Gastrointestinal disorders
nausea
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.1%
3/42 • Up to 16 months
|
9.5%
2/21 • Up to 16 months
|
|
Infections and infestations
nocardia infection
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
General disorders
pain
|
4.8%
2/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial Effusions (malignant)
|
4.8%
2/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
pleural effusion (malignant)
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Infections and infestations
pneumonia
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary/upper respiratory infection
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Gastrointestinal disorders
Rectal bleeding
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Gastrointestinal disorders
Rectal proctitis
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Nervous system disorders
Somnolence
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Cardiac disorders
Supraventricular Tachycardia
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.9%
5/42 • Up to 16 months
|
9.5%
2/21 • Up to 16 months
|
|
Musculoskeletal and connective tissue disorders
upper extremity pain right arm
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
Other adverse events
| Measure |
TMZ/ABT888 Primary Cohort
n=42 participants at risk
Primary cohort included patients unselected for BRCA1/2 mutations or breast cancer subtype.
Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30-40 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated
ABT-888: Capsules (30-40 mg) taken orally twice a day on days 1-7 of each 28 day cycle
temozolomide: Capsules (150 mg/m\^2 initially, and 200 mg/m\^2 starting cycle 2 if tolerated) taken orally once a day on days 1 through 5 of a 28 day cycle
|
TMZ/ABT888 Expansion Cohort
n=21 participants at risk
Expansion cohort included patients with BRCA1/2 deleterious mutations.
Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated
ABT-888: Capsules (30-40 mg) taken orally twice a day on days 1-7 of each 28 day cycle
temozolomide: Capsules (150 mg/m\^2 initially, and 200 mg/m\^2 starting cycle 2 if tolerated) taken orally once a day on days 1 through 5 of a 28 day cycle
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
4.8%
2/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
42/42 • Up to 16 months
|
95.2%
20/21 • Up to 16 months
|
|
Psychiatric disorders
Anxiety
|
2.4%
1/42 • Up to 16 months
|
9.5%
2/21 • Up to 16 months
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Nervous system disorders
Ataxia
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
4.8%
2/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - other
|
0.00%
0/42 • Up to 16 months
|
9.5%
2/21 • Up to 16 months
|
|
Eye disorders
Blurred vision
|
2.4%
1/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Investigations
Coagulation disorders - other
|
0.00%
0/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Gastrointestinal disorders
Constipation
|
97.6%
41/42 • Up to 16 months
|
95.2%
20/21 • Up to 16 months
|
|
General disorders
Constitutional Symptoms - other
|
7.1%
3/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.0%
8/42 • Up to 16 months
|
9.5%
2/21 • Up to 16 months
|
|
Blood and lymphatic system disorders
Decreased Bone marrow cellularity
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Decreased FEV
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Blood and lymphatic system disorders
Decreased hemoglobin
|
97.6%
41/42 • Up to 16 months
|
95.2%
20/21 • Up to 16 months
|
|
Blood and lymphatic system disorders
Decreased leukocytes
|
97.6%
41/42 • Up to 16 months
|
95.2%
20/21 • Up to 16 months
|
|
Blood and lymphatic system disorders
Decreased neutrophils
|
95.2%
40/42 • Up to 16 months
|
100.0%
21/21 • Up to 16 months
|
|
Blood and lymphatic system disorders
Decreased platelets
|
100.0%
42/42 • Up to 16 months
|
95.2%
20/21 • Up to 16 months
|
|
Musculoskeletal and connective tissue disorders
decreased upper extremity function
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
6/42 • Up to 16 months
|
9.5%
2/21 • Up to 16 months
|
|
Psychiatric disorders
Depression
|
11.9%
5/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin - other
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Gastrointestinal disorders
Diarrhea
|
97.6%
41/42 • Up to 16 months
|
95.2%
20/21 • Up to 16 months
|
|
Nervous system disorders
Dizziness
|
14.3%
6/42 • Up to 16 months
|
14.3%
3/21 • Up to 16 months
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Nervous system disorders
Dysgeusia
|
2.4%
1/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
7/42 • Up to 16 months
|
9.5%
2/21 • Up to 16 months
|
|
General disorders
Edema: limb
|
7.1%
3/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Gastrointestinal disorders
Esophagitis
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Eye disorders
Eyelid dysfunction
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
General disorders
Fatigue
|
100.0%
42/42 • Up to 16 months
|
100.0%
21/21 • Up to 16 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
97.6%
41/42 • Up to 16 months
|
100.0%
21/21 • Up to 16 months
|
|
General disorders
Fever
|
97.6%
41/42 • Up to 16 months
|
100.0%
21/21 • Up to 16 months
|
|
General disorders
Flu like syndrome
|
0.00%
0/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Vascular disorders
Flushing
|
4.8%
2/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Injury, poisoning and procedural complications
Fracture
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance
|
2.4%
1/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Gastrointestinal disorders
Gastritis
|
2.4%
1/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Gastrointestinal disorders
Gastrointestinal - other
|
4.8%
2/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Renal and urinary disorders
Genitourinary obstruction
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia
|
97.6%
41/42 • Up to 16 months
|
95.2%
20/21 • Up to 16 months
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
7.1%
3/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Vascular disorders
Hematoma
|
0.00%
0/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Gastrointestinal disorders
Hemorrhage, GI (lower GI NOS)
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory (Mediastinum)
|
4.8%
2/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Vascular disorders
Hot flashes/flushes
|
0.00%
0/42 • Up to 16 months
|
9.5%
2/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
11.9%
5/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
33.3%
14/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
97.6%
41/42 • Up to 16 months
|
95.2%
20/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.8%
2/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Vascular disorders
Hypertension
|
9.5%
4/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
28.6%
12/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.8%
2/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.8%
2/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
31.0%
13/42 • Up to 16 months
|
14.3%
3/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
21.4%
9/42 • Up to 16 months
|
14.3%
3/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
31.0%
13/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.9%
5/42 • Up to 16 months
|
9.5%
2/21 • Up to 16 months
|
|
Vascular disorders
Hypotension
|
4.8%
2/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
2/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Increased alkaline phosphatase
|
45.2%
19/42 • Up to 16 months
|
23.8%
5/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Increased ALT
|
97.6%
41/42 • Up to 16 months
|
95.2%
20/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Increased AST
|
97.6%
41/42 • Up to 16 months
|
95.2%
20/21 • Up to 16 months
|
|
Investigations
Increased creatinine
|
4.8%
2/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Investigations
Increased PTT (Partial Thromboplastin time)
|
0.00%
0/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Infections and infestations
Infection - other
|
19.0%
8/42 • Up to 16 months
|
9.5%
2/21 • Up to 16 months
|
|
Psychiatric disorders
Insomnia
|
19.0%
8/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Musculoskeletal and connective tissue disorders
Joint-effusion
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Musculoskeletal and connective tissue disorders
Lower extremity muscle weakness
|
2.4%
1/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Blood and lymphatic system disorders
Lymphatics - other
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
35.7%
15/42 • Up to 16 months
|
19.0%
4/21 • Up to 16 months
|
|
Metabolism and nutrition disorders
Metabolic/laboratory - other
|
11.9%
5/42 • Up to 16 months
|
9.5%
2/21 • Up to 16 months
|
|
Gastrointestinal disorders
Mucositis (oral cavity)
|
2.4%
1/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Gastrointestinal disorders
Nausea
|
100.0%
42/42 • Up to 16 months
|
100.0%
21/21 • Up to 16 months
|
|
Nervous system disorders
Neurology - other
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Nervous system disorders
Neuropathy: cranial
|
4.8%
2/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Nervous system disorders
Neuropathy: sensory
|
19.0%
8/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Gastrointestinal disorders
Obstruction, GI (Ileum)
|
0.00%
0/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Eye disorders
Ocular/visual - other
|
4.8%
2/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
General disorders
Pain
|
97.6%
41/42 • Up to 16 months
|
95.2%
20/21 • Up to 16 months
|
|
Cardiac disorders
Palpitations
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Gastrointestinal disorders
Perforation, GI (small bowel NOS)
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Cardiac disorders
Pericardial effusion
|
4.8%
2/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Eye disorders
Photophobia
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
97.6%
41/42 • Up to 16 months
|
95.2%
20/21 • Up to 16 months
|
|
Skin and subcutaneous tissue disorders
Rash: Eythema multiforme
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
7.1%
3/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Cardiac disorders
Sinus tachycardia
|
4.8%
2/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Nervous system disorders
Somnolence
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Nervous system disorders
Speech impairment
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
General disorders
Sweating (diaphoresis)
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Vascular disorders
Thrombosis
|
4.8%
2/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Ear and labyrinth disorders
Tinnitus
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Nervous system disorders
Tremor
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
Musculoskeletal and connective tissue disorders
Upper extremity muscle weakness
|
0.00%
0/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes
|
4.8%
2/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
Gastrointestinal disorders
Vomiting
|
97.6%
41/42 • Up to 16 months
|
95.2%
20/21 • Up to 16 months
|
|
Eye disorders
Watery eye
|
2.4%
1/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
|
General disorders
Weight gain
|
0.00%
0/42 • Up to 16 months
|
4.8%
1/21 • Up to 16 months
|
|
General disorders
Weight loss
|
4.8%
2/42 • Up to 16 months
|
0.00%
0/21 • Up to 16 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place