Trial Outcomes & Findings for Cisplatin With or Without Veliparib in Treating Patients With Recurrent or Metastatic Triple-Negative and/or BRCA Mutation-Associated Breast Cancer With or Without Brain Metastases (NCT NCT02595905)
NCT ID: NCT02595905
Last Updated: 2026-04-08
Results Overview
Veliparib will be compared to no veliparib in the BRCA mutation-carriers, BRCA mutation-negative BRCAness-like group, and BRCA mutation-negative non-BRCA-like group. A stratified log-rank test will be used to compare PFS between the two arms in an intention to treat (ITT) analysis where stratification is by line of therapy. A stratified log-rank test will be used to compare PFS between the two arms in an ITT analysis where stratification is by Modified Breast-Graded Prognostic Assessment (GPA) and prior systemic therapies. Progression is defined as radiologic progression of disease by RECIST criteria or unequivocal progression of nonmeasurable disease in the opinion of the treating physician. Progression in the brain metastases cohort is defined as the first detection of radiologic progression of intracranial, extracranial or both intracranial and extracranial disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
344 participants
Primary outcome timeframe
Time from registration (randomization) to progression or death due to any cause, assessed up to 5 years
Results posted on
2026-04-08
Participant Flow
Participant milestones
| Measure |
Arm I (Cisplatin and Placebo)
Patients receive cisplatin IV over 1 hour on day 1 and placebo PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
|
Arm II (Cisplatin and Veliparib)
Patients receive cisplatin IV over 1 hour on day 1 and veliparib PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Veliparib: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
170
|
174
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
170
|
174
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cisplatin With or Without Veliparib in Treating Patients With Recurrent or Metastatic Triple-Negative and/or BRCA Mutation-Associated Breast Cancer With or Without Brain Metastases
Baseline characteristics by cohort
| Measure |
Arm I (Cisplatin and Placebo)
n=158 Participants
Patients receive cisplatin IV over 1 hour on day 1 and placebo PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
|
Arm II (Cisplatin and Veliparib)
n=162 Participants
Patients receive cisplatin IV over 1 hour on day 1 and veliparib PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Veliparib: Given PO
|
Total
n=320 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=527 Participants
|
56 years
n=527 Participants
|
56 years
n=1054 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=527 Participants
|
162 Participants
n=527 Participants
|
319 Participants
n=1054 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
1 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
White
|
116 Participants
n=527 Participants
|
129 Participants
n=527 Participants
|
245 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Black
|
28 Participants
n=527 Participants
|
23 Participants
n=527 Participants
|
51 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=527 Participants
|
6 Participants
n=527 Participants
|
11 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
9 Participants
n=527 Participants
|
4 Participants
n=527 Participants
|
13 Participants
n=1054 Participants
|
PRIMARY outcome
Timeframe: Time from registration (randomization) to progression or death due to any cause, assessed up to 5 yearsPopulation: Participants were only analyzed for this endpoint if they were able to be assigned to one of these three cohorts.
Veliparib will be compared to no veliparib in the BRCA mutation-carriers, BRCA mutation-negative BRCAness-like group, and BRCA mutation-negative non-BRCA-like group. A stratified log-rank test will be used to compare PFS between the two arms in an intention to treat (ITT) analysis where stratification is by line of therapy. A stratified log-rank test will be used to compare PFS between the two arms in an ITT analysis where stratification is by Modified Breast-Graded Prognostic Assessment (GPA) and prior systemic therapies. Progression is defined as radiologic progression of disease by RECIST criteria or unequivocal progression of nonmeasurable disease in the opinion of the treating physician. Progression in the brain metastases cohort is defined as the first detection of radiologic progression of intracranial, extracranial or both intracranial and extracranial disease.
Outcome measures
| Measure |
Arm I (Cisplatin and Placebo)
n=121 Participants
Patients receive cisplatin IV over 1 hour on day 1 and placebo PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
|
Arm II (Cisplatin and Veliparib)
n=126 Participants
Patients receive cisplatin IV over 1 hour on day 1 and veliparib PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Veliparib: Given PO
|
|---|---|---|
|
Progression-free Survival (PFS)
germline BRCA1/2-mutated
|
6.4 months
Interval 4.3 to 8.2
|
6.2 months
Interval 2.3 to 9.2
|
|
Progression-free Survival (PFS)
BRCA-like
|
4.2 months
Interval 2.3 to 5.0
|
5.9 months
Interval 4.3 to 7.8
|
|
Progression-free Survival (PFS)
non-BRCA-like
|
3.0 months
Interval 2.2 to 4.4
|
4.0 months
Interval 2.5 to 4.7
|
SECONDARY outcome
Timeframe: Time from registration to death due to any cause, assessed up to a minimum of 5 yearsPopulation: Only participants who were assigned to one of these three sub-groups.
Veliparib will be compared to no veliparib in the BRCA mutation-carriers, BRCA mutation-negative BRCAness-like group, and BRCA mutation-negative non-BRCA-like group. A stratified log-rank test will be used to compare OS between the two arms in an ITT analysis where stratification is line by line. In the Progressive Brain Metastases Cohort, veliparib will be compared to no veliparib in patients with active brain metastases that are progressive after prior intracranial therapy. A stratified log-rank test will be used to compare OS between the two arms in an ITT analysis where stratification is by Modified Breast-GPA and prior systemic therapies.
Outcome measures
| Measure |
Arm I (Cisplatin and Placebo)
n=121 Participants
Patients receive cisplatin IV over 1 hour on day 1 and placebo PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
|
Arm II (Cisplatin and Veliparib)
n=126 Participants
Patients receive cisplatin IV over 1 hour on day 1 and veliparib PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Veliparib: Given PO
|
|---|---|---|
|
Overall Survival (OS)
BRCA-like
|
12.1 months
Interval 9.0 to 15.9
|
14.0 months
Interval 10.3 to 20.2
|
|
Overall Survival (OS)
germline BRCA1/2-mutated
|
15.6 months
Interval 12.6 to 21.4
|
14.2 months
Interval 8.1 to 21.0
|
|
Overall Survival (OS)
non-BRCA
|
11.1 months
Interval 8.2 to 16.1
|
10.9 months
Interval 8.5 to 13.1
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Only patients with measurable disease in the BRCA-like and non-BRCA groups were analyzed for response rate.
Response rate will be analyzed for patients with measurable disease. Patients who achieve complete or partial response will be classified as having a response. The primary analyses will be conducted using these binary responses using Fisher's exact test and logistic regression. Complete Response: Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below). No new lesions. No disease related symptoms. Partial Response: Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.
Outcome measures
| Measure |
Arm I (Cisplatin and Placebo)
n=79 Participants
Patients receive cisplatin IV over 1 hour on day 1 and placebo PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
|
Arm II (Cisplatin and Veliparib)
n=94 Participants
Patients receive cisplatin IV over 1 hour on day 1 and veliparib PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Veliparib: Given PO
|
|---|---|---|
|
Response Rate (Measurable Disease Only)
germline BRCA-like
|
12 Participants
|
21 Participants
|
|
Response Rate (Measurable Disease Only)
non-BRCA
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Only patients with measurable disease in the BRCA-like and non-BRCA groups were analyzed for clinical benefit.
Clinical benefit will be assessed in patients with measurable disease. The primary analyses will be conducted using these binary responses using Fisher's exact test and logistic regression.
Outcome measures
| Measure |
Arm I (Cisplatin and Placebo)
n=79 Participants
Patients receive cisplatin IV over 1 hour on day 1 and placebo PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
|
Arm II (Cisplatin and Veliparib)
n=94 Participants
Patients receive cisplatin IV over 1 hour on day 1 and veliparib PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Veliparib: Given PO
|
|---|---|---|
|
Clinical Benefit Rate
BRCA-like
|
20 Participants
|
26 Participants
|
|
Clinical Benefit Rate
non-BRCA
|
21 Participants
|
23 Participants
|
Adverse Events
Arm I (Cisplatin and Placebo)
Serious events: 53 serious events
Other events: 140 other events
Deaths: 135 deaths
Arm II (Cisplatin and Veliparib)
Serious events: 47 serious events
Other events: 150 other events
Deaths: 133 deaths
Serious adverse events
| Measure |
Arm I (Cisplatin and Placebo)
n=158 participants at risk
Patients receive cisplatin IV over 1 hour on day 1 and placebo PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given PO
|
Arm II (Cisplatin and Veliparib)
n=162 participants at risk
Patients receive cisplatin IV over 1 hour on day 1 and veliparib PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Veliparib: Given PO
|
|---|---|---|
|
Psychiatric disorders
Depression
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Blood and lymphatic system disorders
Anemia
|
2.5%
4/158 • 5 years or until death.
|
3.7%
6/162 • 5 years or until death.
|
|
Cardiac disorders
Atrial fibrillation
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Cardiac disorders
Cardiac disorders-Other
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Cardiac disorders
Heart failure
|
1.3%
2/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Cardiac disorders
Pericardial effusion
|
1.3%
2/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Cardiac disorders
Pericardial tamponade
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/158 • 5 years or until death.
|
1.2%
2/162 • 5 years or until death.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Ear and labyrinth disorders
Vertigo
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Eye disorders
Blurred vision
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
2/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/158 • 5 years or until death.
|
1.2%
2/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Diarrhea
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Dysphagia
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
8/158 • 5 years or until death.
|
5.6%
9/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
7/158 • 5 years or until death.
|
5.6%
9/162 • 5 years or until death.
|
|
General disorders
Edema limbs
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
General disorders
Fatigue
|
1.9%
3/158 • 5 years or until death.
|
1.2%
2/162 • 5 years or until death.
|
|
General disorders
Fever
|
3.2%
5/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
General disorders
Flu like symptoms
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
General disorders
Infusion related reaction
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
General disorders
Pain
|
0.63%
1/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Infections and infestations
Infections and infestations-Other
|
2.5%
4/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Infections and infestations
Lung infection
|
2.5%
4/158 • 5 years or until death.
|
1.2%
2/162 • 5 years or until death.
|
|
Infections and infestations
Sepsis
|
0.00%
0/158 • 5 years or until death.
|
1.2%
2/162 • 5 years or until death.
|
|
Infections and infestations
Skin infection
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Infections and infestations
Upper respiratory infection
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Investigations
Alanine aminotransferase increased
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Investigations
Alkaline phosphatase increased
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
2/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Investigations
Creatinine increased
|
2.5%
4/158 • 5 years or until death.
|
1.2%
2/162 • 5 years or until death.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/158 • 5 years or until death.
|
1.2%
2/162 • 5 years or until death.
|
|
Investigations
Platelet count decreased
|
1.9%
3/158 • 5 years or until death.
|
1.9%
3/162 • 5 years or until death.
|
|
Investigations
Weight loss
|
0.00%
0/158 • 5 years or until death.
|
1.9%
3/162 • 5 years or until death.
|
|
Investigations
White blood cell decreased
|
0.00%
0/158 • 5 years or until death.
|
1.9%
3/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/158 • 5 years or until death.
|
1.2%
2/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
4/158 • 5 years or until death.
|
2.5%
4/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/158 • 5 years or until death.
|
1.2%
2/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.3%
2/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.5%
4/158 • 5 years or until death.
|
2.5%
4/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/158 • 5 years or until death.
|
1.2%
2/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.3%
2/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/158 • 5 years or until death.
|
1.9%
3/162 • 5 years or until death.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
2.5%
4/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Nervous system disorders
Dizziness
|
0.63%
1/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Nervous system disorders
Seizure
|
1.9%
3/158 • 5 years or until death.
|
1.9%
3/162 • 5 years or until death.
|
|
Nervous system disorders
Syncope
|
2.5%
4/158 • 5 years or until death.
|
1.2%
2/162 • 5 years or until death.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Psychiatric disorders
Confusion
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Psychiatric disorders
Psychiatric disorders-Other
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
3/158 • 5 years or until death.
|
1.2%
2/162 • 5 years or until death.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Renal and urinary disorders
Hematuria
|
0.63%
1/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Reproductive system and breast disorders
Breast pain
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.5%
4/158 • 5 years or until death.
|
4.3%
7/162 • 5 years or until death.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
3/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
3/158 • 5 years or until death.
|
1.9%
3/162 • 5 years or until death.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.63%
1/158 • 5 years or until death.
|
0.00%
0/162 • 5 years or until death.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
4/158 • 5 years or until death.
|
1.2%
2/162 • 5 years or until death.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Vascular disorders
Hypertension
|
0.00%
0/158 • 5 years or until death.
|
1.9%
3/162 • 5 years or until death.
|
|
Vascular disorders
Hypotension
|
0.00%
0/158 • 5 years or until death.
|
0.62%
1/162 • 5 years or until death.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/158 • 5 years or until death.
|
1.2%
2/162 • 5 years or until death.
|
|
Vascular disorders
Thromboembolic event
|
4.4%
7/158 • 5 years or until death.
|
2.5%
4/162 • 5 years or until death.
|
Other adverse events
| Measure |
Arm I (Cisplatin and Placebo)
n=158 participants at risk
Patients receive cisplatin IV over 1 hour on day 1 and placebo PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given PO
|
Arm II (Cisplatin and Veliparib)
n=162 participants at risk
Patients receive cisplatin IV over 1 hour on day 1 and veliparib PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Veliparib: Given PO
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.2%
24/158 • 5 years or until death.
|
22.2%
36/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
22.8%
36/158 • 5 years or until death.
|
25.9%
42/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.7%
20/158 • 5 years or until death.
|
10.5%
17/162 • 5 years or until death.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
9/158 • 5 years or until death.
|
9.9%
16/162 • 5 years or until death.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.1%
16/158 • 5 years or until death.
|
17.3%
28/162 • 5 years or until death.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.7%
9/158 • 5 years or until death.
|
9.3%
15/162 • 5 years or until death.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.6%
12/158 • 5 years or until death.
|
9.3%
15/162 • 5 years or until death.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.1%
16/158 • 5 years or until death.
|
14.2%
23/162 • 5 years or until death.
|
|
Nervous system disorders
Dizziness
|
14.6%
23/158 • 5 years or until death.
|
18.5%
30/162 • 5 years or until death.
|
|
Nervous system disorders
Dysgeusia
|
23.4%
37/158 • 5 years or until death.
|
13.6%
22/162 • 5 years or until death.
|
|
Nervous system disorders
Headache
|
25.3%
40/158 • 5 years or until death.
|
23.5%
38/162 • 5 years or until death.
|
|
Nervous system disorders
Paresthesia
|
7.6%
12/158 • 5 years or until death.
|
5.6%
9/162 • 5 years or until death.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
30.4%
48/158 • 5 years or until death.
|
30.2%
49/162 • 5 years or until death.
|
|
Psychiatric disorders
Anxiety
|
11.4%
18/158 • 5 years or until death.
|
16.0%
26/162 • 5 years or until death.
|
|
Psychiatric disorders
Depression
|
6.3%
10/158 • 5 years or until death.
|
8.0%
13/162 • 5 years or until death.
|
|
Psychiatric disorders
Insomnia
|
12.0%
19/158 • 5 years or until death.
|
11.7%
19/162 • 5 years or until death.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.0%
11/158 • 5 years or until death.
|
1.2%
2/162 • 5 years or until death.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.5%
4/158 • 5 years or until death.
|
4.9%
8/162 • 5 years or until death.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.1%
27/158 • 5 years or until death.
|
19.1%
31/162 • 5 years or until death.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.7%
28/158 • 5 years or until death.
|
23.5%
38/162 • 5 years or until death.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.5%
4/158 • 5 years or until death.
|
4.9%
8/162 • 5 years or until death.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.3%
21/158 • 5 years or until death.
|
13.0%
21/162 • 5 years or until death.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
6.3%
10/158 • 5 years or until death.
|
2.5%
4/162 • 5 years or until death.
|
|
Vascular disorders
Hot flashes
|
10.1%
16/158 • 5 years or until death.
|
6.2%
10/162 • 5 years or until death.
|
|
Vascular disorders
Hypertension
|
16.5%
26/158 • 5 years or until death.
|
17.3%
28/162 • 5 years or until death.
|
|
Investigations
Alanine aminotransferase increased
|
11.4%
18/158 • 5 years or until death.
|
7.4%
12/162 • 5 years or until death.
|
|
Investigations
Alkaline phosphatase increased
|
17.7%
28/158 • 5 years or until death.
|
13.6%
22/162 • 5 years or until death.
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
21/158 • 5 years or until death.
|
8.6%
14/162 • 5 years or until death.
|
|
Investigations
Creatinine increased
|
18.4%
29/158 • 5 years or until death.
|
16.7%
27/162 • 5 years or until death.
|
|
Investigations
Lymphocyte count decreased
|
25.9%
41/158 • 5 years or until death.
|
26.5%
43/162 • 5 years or until death.
|
|
Investigations
Neutrophil count decreased
|
42.4%
67/158 • 5 years or until death.
|
56.8%
92/162 • 5 years or until death.
|
|
Investigations
Platelet count decreased
|
23.4%
37/158 • 5 years or until death.
|
50.0%
81/162 • 5 years or until death.
|
|
Investigations
Weight loss
|
10.1%
16/158 • 5 years or until death.
|
12.3%
20/162 • 5 years or until death.
|
|
Investigations
White blood cell decreased
|
44.3%
70/158 • 5 years or until death.
|
51.2%
83/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Anorexia
|
23.4%
37/158 • 5 years or until death.
|
30.9%
50/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.1%
16/158 • 5 years or until death.
|
9.9%
16/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.0%
19/158 • 5 years or until death.
|
16.7%
27/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.8%
17/158 • 5 years or until death.
|
14.2%
23/162 • 5 years or until death.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.3%
21/158 • 5 years or until death.
|
14.8%
24/162 • 5 years or until death.
|
|
Blood and lymphatic system disorders
Anemia
|
55.1%
87/158 • 5 years or until death.
|
61.7%
100/162 • 5 years or until death.
|
|
Cardiac disorders
Sinus tachycardia
|
4.4%
7/158 • 5 years or until death.
|
6.8%
11/162 • 5 years or until death.
|
|
Ear and labyrinth disorders
Hearing impaired
|
8.2%
13/158 • 5 years or until death.
|
5.6%
9/162 • 5 years or until death.
|
|
Ear and labyrinth disorders
Tinnitus
|
33.5%
53/158 • 5 years or until death.
|
26.5%
43/162 • 5 years or until death.
|
|
Eye disorders
Blurred vision
|
5.1%
8/158 • 5 years or until death.
|
6.2%
10/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
15/158 • 5 years or until death.
|
11.7%
19/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Constipation
|
38.6%
61/158 • 5 years or until death.
|
35.2%
57/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Diarrhea
|
19.6%
31/158 • 5 years or until death.
|
23.5%
38/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.3%
10/158 • 5 years or until death.
|
10.5%
17/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.2%
5/158 • 5 years or until death.
|
6.8%
11/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Mucositis oral
|
8.2%
13/158 • 5 years or until death.
|
5.6%
9/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Nausea
|
60.1%
95/158 • 5 years or until death.
|
73.5%
119/162 • 5 years or until death.
|
|
Gastrointestinal disorders
Vomiting
|
36.1%
57/158 • 5 years or until death.
|
43.8%
71/162 • 5 years or until death.
|
|
General disorders
Chills
|
1.3%
2/158 • 5 years or until death.
|
5.6%
9/162 • 5 years or until death.
|
|
General disorders
Edema limbs
|
9.5%
15/158 • 5 years or until death.
|
8.0%
13/162 • 5 years or until death.
|
|
General disorders
Fatigue
|
60.1%
95/158 • 5 years or until death.
|
61.1%
99/162 • 5 years or until death.
|
|
General disorders
Fever
|
3.2%
5/158 • 5 years or until death.
|
5.6%
9/162 • 5 years or until death.
|
|
General disorders
Non-cardiac chest pain
|
5.1%
8/158 • 5 years or until death.
|
2.5%
4/162 • 5 years or until death.
|
|
General disorders
Pain
|
11.4%
18/158 • 5 years or until death.
|
13.6%
22/162 • 5 years or until death.
|
|
Infections and infestations
Urinary tract infection
|
5.1%
8/158 • 5 years or until death.
|
4.9%
8/162 • 5 years or until death.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60