Veliparib and Irinotecan Hydrochloride in Treating Patients With Cancer That Is Metastatic or Cannot Be Removed by Surgery

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00576654
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Solid Neoplasm
  • Triple-Negative Breast Carcinoma
  • Unresectable Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan Hydrochloride — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Veliparib — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and best dose of veliparib when given together with irinotecan hydrochloride in treating patients with cancer that has spread to other parts of the body or that cannot be removed by surgery. Irinotecan hydrochloride can kill cancer cells by damaging the deoxyribonucleic acid (DNA) that is needed for cancer cell survival and growth. Veliparib may block proteins that repair the damaged DNA and may help irinotecan hydrochloride to kill more tumor cells. Giving irinotecan hydrochloride together with veliparib may kill more cancer cells.

Key Dates

Start date
Mar 18, 2008
Status verified
Apr 2025
Primary completion
Jan 16, 2020
Completion
Jan 16, 2020

Study Design

Enrollment
73 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation (irinotecan hydrochloride and veliparib)
    Patients receive irinotecan hydrochloride IV over 90 minutes on days 1 and 8 and veliparib PO BID on days -1 to 14 (days 3-14 of course 1 only). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Expansion portion (irinotecan hydrochloride and veliparib)
    Patients receive irinotecan hydrochloride IV over 90 minutes on days 1 and 8 and veliparib PO BID on days 1-15 (days 2-15 of course 1 only). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Intermittent dose escalation (irinotecan, ABT-888)
    Patients receive irinotecan hydrochloride IV over 90 minutes on days 3 and 10 and veliparib PO BID on days 1 to 4 and 8-11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Optimal biologic dose (OBD) [ Time Frame: Up to day 9 of course 1 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06520-
University of Maryland/Greenebaum Cancer CenterBaltimoreMaryland21201-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
Covenant Medical Center HarrisonSaginawMichigan48602-

Find similar trials in New Haven, CT

By research site
Yale University· New Haven, CTUniversity of Maryland/Greenebaum Cancer Center· Baltimore, MDDana-Farber Cancer Institute· Boston, MAWayne State University/Karmanos Cancer Institute· Detroit, MICovenant Medical Center Harrison· Saginaw, MI

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