Trial Outcomes & Findings for Phase I Combination Ixabepilone + Cisplatin (NCT NCT00832117)
NCT ID: NCT00832117
Last Updated: 2020-10-28
Results Overview
DLT=any of the following treatment-related events:Grade(Gr)3/4 diarrhea despite the use of adequate/maximal medical intervention and/or prophylaxis;other Gr3 or greater nonhematological toxicity requiring removal from further study therapy;delayed recovery from treatment-related toxicity delaying scheduled retreatment for \>3 weeks;Gr4 neutropenia (absolute neutrophil count \<500 cells/mm\^3) for \>=5 consecutive days or Gr3/4 neutropenia of any duration with sepsis or fever \>38.5°C;thrombocytopenia \<25,000 cells/mm\^3 or bleeding requiring platelet transfusion. Grades defined in Outcome Measure 7.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Within the first 21 days of first cycle
Results posted on
2020-10-28
Participant Flow
A total of 30 participants were enrolled; 29 were treated (1 participant no longer met study criteria).
Participant milestones
| Measure |
All Enrolled Participants
Participants received both ixabepilone (ixa) 32 mg/m\^2+ cisplatin (cis) 60 mg/m\^2 and ixa 32mg/m\^2+cis 80mg/m\^2, administered intravenously on Day 1 of a 21 day cycle.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
All Enrolled Participants
Participants received both ixabepilone (ixa) 32 mg/m\^2+ cisplatin (cis) 60 mg/m\^2 and ixa 32mg/m\^2+cis 80mg/m\^2, administered intravenously on Day 1 of a 21 day cycle.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Disease Progression
|
11
|
Baseline Characteristics
Phase I Combination Ixabepilone + Cisplatin
Baseline characteristics by cohort
| Measure |
Ixa 32 mg/m^2+Cis 60 mg/m^2
n=24 Participants
6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m\^2+ cisplatin (cis) 60 mg/m\^2 administered intravenously on Day 1 of a 21 day cycle
|
32mg/m^2+Cis 80mg/m^2
n=5 Participants
5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m\^2+cis 80mg/m\^2, administered intravenously on Day 1 of a 21 day cycle
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=93 Participants
|
54 years
n=4 Participants
|
63 years
n=27 Participants
|
|
Age, Customized
< 65 years
|
12 participants
n=93 Participants
|
5 participants
n=4 Participants
|
17 participants
n=27 Participants
|
|
Age, Customized
>= 65 years
|
12 participants
n=93 Participants
|
0 participants
n=4 Participants
|
12 participants
n=27 Participants
|
|
Age, Customized
< 50 years
|
3 participants
n=93 Participants
|
2 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Age, Customized
>= 50 years
|
21 participants
n=93 Participants
|
3 participants
n=4 Participants
|
24 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Karnofsky Performance Status
80 - Activity with effort; some signs of disease
|
9 participants
n=93 Participants
|
2 participants
n=4 Participants
|
11 participants
n=27 Participants
|
|
Karnofsky Performance Status
90 - Normal activity; minor signs of disease
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Karnofsky Performance Status
100 - Normal no complaints; no evidence of disease
|
13 participants
n=93 Participants
|
2 participants
n=4 Participants
|
15 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Within the first 21 days of first cyclePopulation: all treated participants
DLT=any of the following treatment-related events:Grade(Gr)3/4 diarrhea despite the use of adequate/maximal medical intervention and/or prophylaxis;other Gr3 or greater nonhematological toxicity requiring removal from further study therapy;delayed recovery from treatment-related toxicity delaying scheduled retreatment for \>3 weeks;Gr4 neutropenia (absolute neutrophil count \<500 cells/mm\^3) for \>=5 consecutive days or Gr3/4 neutropenia of any duration with sepsis or fever \>38.5°C;thrombocytopenia \<25,000 cells/mm\^3 or bleeding requiring platelet transfusion. Grades defined in Outcome Measure 7.
Outcome measures
| Measure |
Ixa 32 mg/m^2+Cis 60 mg/m^2
n=24 Participants
6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m\^2+ cisplatin (cis) 60 mg/m\^2 administered intravenously on Day 1 of a 21 day cycle
|
32mg/m^2+Cis 80mg/m^2
n=5 Participants
5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m\^2+cis 80mg/m\^2, administered intravenously on Day 1 of a 21 day cycle
|
|---|---|---|
|
Participants Experiencing Dose Limiting Toxicity (DLT)
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Within the first 21 days of first cyclePopulation: All subjects who received at least 1 dose of either ixabepilone or carboplatin
The MTD is defined as the highest dose level in which dose limiting toxicities (DLTs) during the first 21 days of the first treatment cycle are observed in less than 1 out of 3 or less than 2 out of 6 treated subjects with at least 2 subjects experiencing DLT at the next higher dose level.
Outcome measures
| Measure |
Ixa 32 mg/m^2+Cis 60 mg/m^2
n=29 Participants
6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m\^2+ cisplatin (cis) 60 mg/m\^2 administered intravenously on Day 1 of a 21 day cycle
|
32mg/m^2+Cis 80mg/m^2
5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m\^2+cis 80mg/m\^2, administered intravenously on Day 1 of a 21 day cycle
|
|---|---|---|
|
Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Cisplatin in Combination With Ixabepilone, 32 mg/m^2
|
60 mg/m^2
|
—
|
SECONDARY outcome
Timeframe: At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm.Population: All treated participants
Complete Response(CR):Disappearance of all clinical/radiological evidence of target lesions (TL) \& all nontarget lesions (NTL) + no new lesions (NWL). Partial Response(PR):CR of TL + persistence of \>=1 NTL (NonCR/NonPD) + no NWL; OR \>=30% decrease in sum of longest diameter(LD) of all TL + CR or NonCR/NonPD in NTL + no NWL. Progressive Disease (PD):\>=20% increase in sum of LD of TL regardless of NTL \& NWL status; or unequivocal progression of NTL regardless of TL \& NWL status; or NWL regardless of TL \& NTL status. Stable Disease(SD): Neither PD nor PR in TL + CR or NonCR/NonPD in NTL + no NWL.
Outcome measures
| Measure |
Ixa 32 mg/m^2+Cis 60 mg/m^2
n=24 Participants
6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m\^2+ cisplatin (cis) 60 mg/m\^2 administered intravenously on Day 1 of a 21 day cycle
|
32mg/m^2+Cis 80mg/m^2
n=5 Participants
5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m\^2+cis 80mg/m\^2, administered intravenously on Day 1 of a 21 day cycle
|
|---|---|---|
|
Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
Complete Response
|
0 participants
|
0 participants
|
|
Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
Partial Response
|
8 participants
|
0 participants
|
|
Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
Stable Disease
|
10 participants
|
2 participants
|
|
Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
Disease Progression
|
5 participants
|
2 participants
|
|
Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
Not Assessed
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm.Population: This outcome measure was not analyzed as the indication for NSCLC is no longer being pursued.
Response in participants with non-small cell lung cancer (NSCLC) was defined as the number of subjects in whose best response is partial response (PR) or complete response (CR) (see Outcome Measure 3 for definitions) divided by the total number of response evaluable subjects.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The duration of response is measured from the time (in months) measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented progressive disease or death. (Duration of study was approximately 21 months.)Population: This outcome measure was not analyzed as the indication for NSCLC is no longer being pursued.
The duration of response will be computed for all treated subjects whose best response is either partial response (PR) or complete response (CR). The duration of response is measured from the time (in months) measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented progressive disease or death. Subjects who neither relapse nor die will be censored on the date of their last tumor assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2.Population: All treated participants
AE=any new untoward medical occurrence/worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical event that results in death, persistent/significant incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires/prolongs inpatient hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. Grade 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening.
Outcome measures
| Measure |
Ixa 32 mg/m^2+Cis 60 mg/m^2
n=24 Participants
6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m\^2+ cisplatin (cis) 60 mg/m\^2 administered intravenously on Day 1 of a 21 day cycle
|
32mg/m^2+Cis 80mg/m^2
n=5 Participants
5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m\^2+cis 80mg/m\^2, administered intravenously on Day 1 of a 21 day cycle
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
Death
|
4 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
SAEs
|
7 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
Drug-Related SAEs
|
4 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
AEs Leading to Discontinuation
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
Drug-Related AEs Leading to Discontinuation
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
Overall AEs
|
24 participants
|
5 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
Grade 3/4 AEs
|
14 participants
|
3 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
Drug-Related AEs
|
24 participants
|
5 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
Grade 3/4 Drug-Related AEs
|
11 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Assessed at screening and weekly during treatment. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2.Population: All treated participants
Grade (Gr) 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening. Hemoglobin Gr1 \<LLN - 10.0 g/dL; Gr2 \<10.0 - 8.0 g/dL; Gr3 \<8.0 - 6.5 g/dL; Gr4 \<6.5 g/dL. White Blood Cell Count (WBC) Gr1 \<lower limit of normal (LLN) - 3000/mm\^3; Gr2 \<3000 - 2000/mm\^3; Gr3 \<2000 - 1000/mm\^3; Gr4 \<1000/mm\^3. Absolute Neutrophil Count (ANC) Gr 1 \<LLN - 1500/mm\^3; Gr 2 \<1500 - 1000/mm\^3; Gr3 \<1000 - 500/mm\^3; Gr 4 \<500/mm\^3. Platelets Gr1 \<LLN - 75,000/mm\^3; Gr2 \<75,000 - 50,000/mm\^3; Gr3 \<50,000 - 25,000/mm\^3; Gr4 \<25,000/mm\^3. Normal ranges vary by local laboratory.
Outcome measures
| Measure |
Ixa 32 mg/m^2+Cis 60 mg/m^2
n=24 Participants
6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m\^2+ cisplatin (cis) 60 mg/m\^2 administered intravenously on Day 1 of a 21 day cycle
|
32mg/m^2+Cis 80mg/m^2
n=5 Participants
5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m\^2+cis 80mg/m\^2, administered intravenously on Day 1 of a 21 day cycle
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
WBC, Grade 1-4
|
19 participants
|
5 participants
|
|
Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
WBC, Grade 3-4
|
6 participants
|
3 participants
|
|
Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
ANC, Grade 1-4
|
18 participants
|
5 participants
|
|
Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
ANC, Grade 3-4
|
12 participants
|
4 participants
|
|
Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
Platelet Count, Grade 1-4
|
9 participants
|
3 participants
|
|
Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
Platelet Count, Grade 3-4
|
0 participants
|
1 participants
|
|
Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
Hemoglobin, Grade 1-4
|
22 participants
|
5 participants
|
|
Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
Hemoglobin, Grade 3-4
|
1 participants
|
0 participants
|
Adverse Events
Ixa 32 mg/m2 + Cis 60 mg/m2
Serious events: 7 serious events
Other events: 24 other events
Deaths: 0 deaths
Ixa 32 mg/m2 +Cis 80 mg/m2
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixa 32 mg/m2 + Cis 60 mg/m2
n=24 participants at risk
6 participants with solid tumor (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) for NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m\^2+ cisplatin (cis) 60 mg/m\^2 administered intravenously on Day 1 of a 21 day cycle
|
Ixa 32 mg/m2 +Cis 80 mg/m2
n=5 participants at risk
5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m\^2+cis 80mg/m\^2, administered intravenously on Day 1 of a 21 day cycle
|
|---|---|---|
|
Infections and infestations
BACTERAEMIA
|
4.2%
1/24
|
0.00%
0/5
|
|
Gastrointestinal disorders
NAUSEA
|
4.2%
1/24
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
4.2%
1/24
|
0.00%
0/5
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
4.2%
1/24
|
0.00%
0/5
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/24
|
20.0%
1/5
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
4.2%
1/24
|
0.00%
0/5
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
0.00%
0/24
|
20.0%
1/5
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
4.2%
1/24
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
4.2%
1/24
|
0.00%
0/5
|
|
Gastrointestinal disorders
VOMITING
|
8.3%
2/24
|
0.00%
0/5
|
Other adverse events
| Measure |
Ixa 32 mg/m2 + Cis 60 mg/m2
n=24 participants at risk
6 participants with solid tumor (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) for NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m\^2+ cisplatin (cis) 60 mg/m\^2 administered intravenously on Day 1 of a 21 day cycle
|
Ixa 32 mg/m2 +Cis 80 mg/m2
n=5 participants at risk
5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m\^2+cis 80mg/m\^2, administered intravenously on Day 1 of a 21 day cycle
|
|---|---|---|
|
Ear and labyrinth disorders
EAR PRURITUS
|
0.00%
0/24
|
20.0%
1/5
|
|
General disorders
MUCOSAL INFLAMMATION
|
12.5%
3/24
|
0.00%
0/5
|
|
Gastrointestinal disorders
NAUSEA
|
66.7%
16/24
|
60.0%
3/5
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/24
|
20.0%
1/5
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
8.3%
2/24
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.00%
0/24
|
20.0%
1/5
|
|
Infections and infestations
RESPIRATORY MONILIASIS
|
0.00%
0/24
|
20.0%
1/5
|
|
Investigations
TYMPANOMETRY ABNORMAL
|
0.00%
0/24
|
20.0%
1/5
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
8.3%
2/24
|
20.0%
1/5
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/24
|
40.0%
2/5
|
|
Nervous system disorders
DIZZINESS
|
8.3%
2/24
|
20.0%
1/5
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/24
|
20.0%
1/5
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/24
|
20.0%
1/5
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/24
|
20.0%
1/5
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
4.2%
1/24
|
20.0%
1/5
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/24
|
20.0%
1/5
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
12.5%
3/24
|
0.00%
0/5
|
|
Investigations
PLATELET COUNT DECREASED
|
4.2%
1/24
|
20.0%
1/5
|
|
General disorders
PYREXIA
|
12.5%
3/24
|
20.0%
1/5
|
|
Psychiatric disorders
ANXIETY
|
4.2%
1/24
|
20.0%
1/5
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
0.00%
0/24
|
20.0%
1/5
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/24
|
20.0%
1/5
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/24
|
20.0%
1/5
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
12.5%
3/24
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
33.3%
8/24
|
40.0%
2/5
|
|
General disorders
OEDEMA PERIPHERAL
|
12.5%
3/24
|
0.00%
0/5
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/24
|
20.0%
1/5
|
|
Cardiac disorders
TACHYCARDIA
|
8.3%
2/24
|
20.0%
1/5
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/24
|
40.0%
2/5
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
4.2%
1/24
|
20.0%
1/5
|
|
Nervous system disorders
HEADACHE
|
8.3%
2/24
|
20.0%
1/5
|
|
Metabolism and nutrition disorders
HYPERMAGNESAEMIA
|
0.00%
0/24
|
20.0%
1/5
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
12.5%
3/24
|
20.0%
1/5
|
|
General disorders
OEDEMA
|
0.00%
0/24
|
20.0%
1/5
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/24
|
20.0%
1/5
|
|
Investigations
WEIGHT DECREASED
|
8.3%
2/24
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
ANAEMIA
|
16.7%
4/24
|
20.0%
1/5
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.7%
4/24
|
40.0%
2/5
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/24
|
20.0%
1/5
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
0.00%
0/24
|
20.0%
1/5
|
|
General disorders
PAIN
|
12.5%
3/24
|
0.00%
0/5
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/24
|
20.0%
1/5
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
33.3%
8/24
|
60.0%
3/5
|
|
General disorders
ASTHENIA
|
20.8%
5/24
|
20.0%
1/5
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/24
|
20.0%
1/5
|
|
Gastrointestinal disorders
DIARRHOEA
|
25.0%
6/24
|
0.00%
0/5
|
|
Nervous system disorders
DYSGEUSIA
|
20.8%
5/24
|
20.0%
1/5
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/24
|
20.0%
1/5
|
|
Vascular disorders
FLUSHING
|
0.00%
0/24
|
20.0%
1/5
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/24
|
20.0%
1/5
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
12.5%
3/24
|
0.00%
0/5
|
|
Nervous system disorders
NEUROTOXICITY
|
16.7%
4/24
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
RASH
|
12.5%
3/24
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
4.2%
1/24
|
20.0%
1/5
|
|
Investigations
BLOOD CREATININE INCREASED
|
4.2%
1/24
|
20.0%
1/5
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
8.3%
2/24
|
20.0%
1/5
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
8.3%
2/24
|
0.00%
0/5
|
|
Infections and infestations
HERPES VIRUS INFECTION
|
0.00%
0/24
|
20.0%
1/5
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/24
|
20.0%
1/5
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
4.2%
1/24
|
40.0%
2/5
|
|
Gastrointestinal disorders
CONSTIPATION
|
29.2%
7/24
|
80.0%
4/5
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
25.0%
6/24
|
0.00%
0/5
|
|
Ear and labyrinth disorders
EAR CANAL ERYTHEMA
|
0.00%
0/24
|
20.0%
1/5
|
|
General disorders
FATIGUE
|
41.7%
10/24
|
80.0%
4/5
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/24
|
20.0%
1/5
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
4.2%
1/24
|
40.0%
2/5
|
|
Gastrointestinal disorders
VOMITING
|
33.3%
8/24
|
20.0%
1/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER