PARP Inhibitor BMN-673 and Temozolomide or Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT02049593
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Cancer
  • Unspecified Adult Solid Tumor

Eligibility Criteria

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

Interventions

  • PARP inhibitor BMN-673 — DRUG
    Given PO
  • temozolomide — DRUG
    Given PO
  • irinotecan hydrochloride — DRUG
    Given IV
  • pharmacological study — OTHER
    Correlative studies
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This phase I trial studies the side effects and the best dose of poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor BMN-673 when given together with temozolomide or irinotecan hydrochloride in treating patients with locally advanced or metastatic solid tumors. PARP inhibitor BMN-673 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may help temozolomide and irinotecan hydrochloride work better by making tumor cells more sensitive to the drug. Drugs used in chemotherapy, such as temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving PARP inhibitor BMN-673 with temozolomide or irinotecan hydrochloride may be an effective treatment for patients with advanced solid tumors.

Key Dates

Start date
Jun 12, 2014
Status verified
Nov 2019
Primary completion
Oct 7, 2019
Completion
Oct 7, 2019

Study Design

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

Arms

  • Experimental: Arm A (PARP inhibitor BMN-673, temozolomide)
    Patients receive PARP inhibitor BMN-673 PO QD on days 1-28 and temozolomide PO daily on days1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm B (PARP inhibitor BMN-673, irinotecan hydrochloride)
    Patients receive PARP inhibitor BNM-673 as in Arm A and irinotecan hydrochloride IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Dose Limiting Toxicity graded using the NCI CTCAE v. 4.03 [ Time Frame: Up to 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095-

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By research site
Jonsson Comprehensive Cancer Center· Los Angeles, CA

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