NCT01282333

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Last Updated

July 2, 2013

Status Verified

July 1, 2013

Enrollment Period

2.1 years

First QC Date

January 22, 2011

Last Update Submit

July 1, 2013

Conditions

Advanced Adult Primary Liver CancerLocalized Unresectable Adult Primary Liver CancerMetastatic Transitional Cell Cancer of the Renal Pelvis and UreterRegional Transitional Cell Cancer of the Renal Pelvis and UreterStage III Bladder CancerStage III Pancreatic CancerStage IIIA Non-small Cell Lung CancerStage IIIB Non-small Cell Lung CancerStage IV Bladder CancerStage IV Non-small Cell Lung CancerStage IV Pancreatic CancerTransitional Cell Carcinoma of the BladderUnresectable Extrahepatic Bile Duct CancerUnresectable Gallbladder Cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum-tolerated dose of veliparib in combination with cisplatin and gemcitabine

    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).

    21 days

Secondary Outcomes (2)

  • Dose-limiting and other toxicities according to CTCAE v4.0

    Up to 4 weeks post-treatment

  • Recommended phase II dose

    Up to 4 weeks post-treatment

Study Arms (1)

Treatment (veliparib, gemcitabine hydrochloride, cisplatin)

EXPERIMENTAL

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.

Drug: gemcitabine hydrochlorideDrug: veliparibOther: diagnostic laboratory biomarker analysisOther: pharmacological studyDrug: cisplatin

Interventions

gemcitabine hydrochlorideDRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Treatment (veliparib, gemcitabine hydrochloride, cisplatin)
veliparibDRUG

Given orally

Also known as: ABT-888
Treatment (veliparib, gemcitabine hydrochloride, cisplatin)
diagnostic laboratory biomarker analysisOTHER

Correlative studies

Treatment (veliparib, gemcitabine hydrochloride, cisplatin)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (veliparib, gemcitabine hydrochloride, cisplatin)
cisplatinDRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP
Treatment (veliparib, gemcitabine hydrochloride, cisplatin)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsPancreatic NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

GemcitabineveliparibCisplatin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Leonard Appleman

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2011

First Posted

January 25, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2013

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations

US(3)