Clinical trial · Interventional
Veliparib, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Biliary, Pancreatic, Urothelial, or Non-Small Cell Lung Cancer
Phase I Study of Veliparib (ABT-888) in Combination With Cisplatin Plus Gemcitabine in Advanced Biliary, Pancreatic, Urothelial, and Non-small Cell Lung Cancer
NCT01282333CI-TRIAL-00011170terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I clinical trial is studying the side effects and best dose of veliparib and gemcitabine hydrochloride when given with cisplatin in treating patients with advanced biliary, pancreatic, urothelial, or non-small cell lung cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Veliparib may help cisplatin and gemcitabine hydrochloride work better by making tumor cells more sensitive to the drugs.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Localized Unresectable Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter | — | UNRESOLVED | — |
| Regional Transitional Cell Cancer of the Renal Pelvis and Ureter | — | UNRESOLVED | — |
| Stage IIIA Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| diagnostic laboratory biomarker analysis | Other | — | UNRESOLVED |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
| veliparib | Drug | Veliparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (veliparib, gemcitabine hydrochloride, cisplatin)
- description
- Patients receive veliparib orally every 12 hours on days 1-12, gemcitabine hydrochloride IV over 30 minutes on days 3 and 10, and cisplatin IV over 60-120 minutes on day 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with suspected or known germline BRCA mutations may continue to receive single-agent veliparib continuously in the absence of disease progression or unacceptable toxicity. Patients may undergo blood, tumor tissue, and hair follicle sample collection periodically for pharmacokinetic and correlative studies.
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: veliparib
- Other: diagnostic laboratory biomarker analysis
- Other: pharmacological study
- Drug: cisplatin
Primary outcomes (1)
- measure
- Maximum-tolerated dose of veliparib in combination with cisplatin and gemcitabine
- timeFrame
- 21 days
- description
- The maximum toxicity for each category of interest that are determined to be possibly, probably or definitely related to study treatment will be recorded for each patient and the summary results will be tabulated (according to CTCAE v4.0).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically or cytologically confirmed advanced biliary/pancreatic cancer, urothelial cancer, or non-small cell lung cancer that is metastatic or unresectable * Patients with known CNS metastases should be excluded from this clinical trial * ECOG performance status ≤ 2 (Karnofsky ≥ 60%) * Life expectancy of greater than 12 weeks * Absolute neutrophil count ≥ 1,500/mcL * Platelets ≥ 100,000/mcL * Total bilirubin within normal institutional limits * AST/ALT ≤ 2.5 times institutional upper limit of normal * Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min * QTc interval on ECG ≤ 0.48 seconds by Bazett's calculation (≤ CTCAE v.4 grade 2) * Not pregnant or nursing * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation * Patients must be able to swallow pills and have no significant impairment in gastrointestinal absorption * Patients with known or suspected germline mutation in BRCA1 or BRCA2 are eligible to participate * Patients in study screening (primarily those with pancreatic cancer) who have a family history that is suspicious for BRCA1 or BRCA2 germline mutation should be assessed by the BRCAPRO computer program to quantitate the likelihood of harboring a deleterious BRCA mutation * Patients found to have a BRCAPRO probability score of ≥ 20% should undergo formal full-sequence BRCA testing * Patients in screening with a BRCAPRO probability of ≥ 20% who decline genetic testing are not eligible to participate in this trial due to the potential to confound safety assessment * No uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements * HIV-positive patients are eligible * No active seizure or history of seizure disorder * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib (ABT-888) or other agents used in this study * No peripheral neuropathy greater than grade1 * No prior systemic treatment * No prior cytotoxic chemotherapy (neoadjuvant, adjuvant, or metastatic setting) * At least 4 weeks since major surgery or radiation therapy * Patients may not be receiving any other investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.