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Veliparib, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Biliary, Pancreatic, Urothelial, or Non-Small Cell Lung Cancer

NCT01282333 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2013-07-02

No results posted yet for this study

Summary

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

  • Advanced Adult Primary Liver Cancer
  • Localized Unresectable Adult Primary Liver Cancer
  • Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Stage III Bladder Cancer
  • Stage III Pancreatic Cancer
  • Stage IIIA Non-small Cell Lung Cancer
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IV Bladder Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Stage IV Pancreatic Cancer
  • Transitional Cell Carcinoma of the Bladder
  • Unresectable Extrahepatic Bile Duct Cancer
  • Unresectable Gallbladder Cancer

Interventions

DRUG

gemcitabine hydrochloride

Given IV

DRUG

veliparib

Given orally

OTHER

diagnostic laboratory biomarker analysis

Correlative studies

OTHER

pharmacological study

Correlative studies

DRUG

cisplatin

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Leonard Appleman · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01282333 on ClinicalTrials.gov