NCT01233505

Brief Summary

This phase I trial is studying the side effects and the best dose of veliparib when given together with capecitabine and oxaliplatin in treating patients with advanced solid tumors. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving veliparib together with capecitabine and oxaliplatin may kill more tumor cells.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

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

October 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Last Updated

April 2, 2014

Status Verified

October 1, 2013

Enrollment Period

3 years

First QC Date

November 2, 2010

Last Update Submit

April 1, 2014

Conditions

Adenocarcinoma of the PancreasAdenocarcinoma of the StomachBRCA1 Mutation CarrierBRCA2 Mutation CarrierOvarian Mucinous CystadenocarcinomaRecurrent Breast CancerRecurrent Colon CancerRecurrent Gastric CancerRecurrent Ovarian Epithelial CancerRecurrent Ovarian Germ Cell TumorRecurrent Pancreatic CancerRecurrent Rectal CancerStage IA Breast CancerStage IB Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Breast CancerStage IV Colon CancerStage IV Gastric CancerStage IV Ovarian Epithelial CancerStage IV Ovarian Germ Cell TumorStage IV Pancreatic CancerStage IV Rectal CancerUnspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

  • Maximum-tolerated (MTD) dose of veliparib in combination with oxaliplatin and capecitabine as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    MTD defined as the dose level at which less than one-third of patients experience a dose-limiting toxicity (DLT).

    28 days

  • Dose-limiting toxicities of veliparib in combination with oxaliplatin and capecitabine as assessed by NCI CTCAE version 4.0

    28 days

Secondary Outcomes (3)

  • Pharmacokinetics of veliparib administered concomitantly with oxaliplatin and capecitabine

    At baseline, at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours of days 1 and 7

  • Safety and tolerability as assessed by NCI CTCAE version 4.0

    Up to 30 days

  • Anti-tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST)

    Up to 30 days

Study Arms (1)

Treatment (veliparib, capecitabine, oxaliplatin)

EXPERIMENTAL

Patients receive veliparib PO twice daily and capecitabine PO twice daily on 1-7 and 15-21, and oxaliplatin IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: veliparibDrug: capecitabineDrug: oxaliplatinOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

veliparibDRUG

Given PO

Also known as: ABT-888
Treatment (veliparib, capecitabine, oxaliplatin)
capecitabineDRUG

Given PO

Also known as: CAPE, Ro 09-1978/000, Xeloda
Treatment (veliparib, capecitabine, oxaliplatin)
oxaliplatinDRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Treatment (veliparib, capecitabine, oxaliplatin)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (veliparib, capecitabine, oxaliplatin)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (veliparib, capecitabine, oxaliplatin)

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed solid tumors that fulfill ≥ 1 of the following criteria:
  • BRCA1/2 mutation and a BRCA-related malignancy
  • Patients without a known BRCA mutation must have a probability of harboring a BRCA gene mutation as assessed by BRCAPRO computer program
  • Patients with a probability of having genetic mutation ≥ 20% or a BRCA mutation based on a non-Myriad test, must have a formal BRCA testing by Myriad Genetic Laboratories
  • Patients with known deleterious BRCA 1 or 2 mutation or a mutation of uncertain significance
  • Patients who refuse BRCA testing not allowed unless they have another acceptable histology
  • First- or second-line metastatic colorectal cancer
  • Any-line metastatic mucinous ovarian cancer
  • Any line of other metastatic gastrointestinal malignancies in which oxaliplatin has shown some activity (i.e., gastric or pancreatic adenocarcinoma)
  • Patients with uncontrolled CNS metastasis are not eligible; patients with CNS metastases who have had them treated and are stable for \> 3 months will be eligible; patients must be off steroid treatment prior to study enrollment
  • Measurable disease
  • Patients with ovarian cancer who have a pre-treatment CA 125 level of at least twice the upper limit of normal allowed
  • ECOG performance status (PS) 0-2 (Karnofsky 60-100%)
  • Life expectancy \> 3 months
  • ANC ≥ 1,500/mm³
  • +33 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsColonic NeoplasmsStomach NeoplasmsCarcinoma, Ovarian EpithelialPancreatic NeoplasmsRectal Neoplasms

Interventions

veliparibCapecitabineOxaliplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesStomach DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination ComplexesOrganic Chemicals

Study Officials

  • William Schelman

    University of Wisconsin, Madison

    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

November 2, 2010

First Posted

November 3, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2013

Last Updated

April 2, 2014

Record last verified: 2013-10

Locations

US(1)