MPACT Study to Compare Effects of Targeted Drugs on Tumor Gene Variations

Part of paid clinical trials in Aurora, Colorado.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01827384
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Malignant Solid Neoplasm

Eligibility Criteria

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

Interventions

  • Adavosertib — DRUG
    Given by mouth (PO)
  • Carboplatin — DRUG
    Given intravenous (IV)
  • Everolimus — DRUG
    Given by mouth (PO)
  • Temozolomide — DRUG
    Given by mouth (PO)
  • Trametinib — DRUG
    Given by mouth (PO)
  • Veliparib — DRUG
    Given by mouth (PO)

Study Details

This phase II trial studies molecular profiling-based assignment of cancer therapy (MPACT) in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Adavosertib, everolimus, and trametinib are drugs that each target a specific variation in tumors by blocking different proteins needed for cell growth. Veliparib blocks an enzyme that helps repair deoxyribonucleic acid (DNA) damaged by chemotherapy, which may help chemotherapy drugs work better. It is not yet known whether testing patients for variations in their tumor and assigning treatment targeting the variation is more effective than standard non-targeted therapy in treating advanced solid tumors.

Key Dates

Start date
Jan 7, 2014
Status verified
Sep 2023
Primary completion
Jun 19, 2021
Completion
Oct 8, 2021

Study Design

Enrollment
208 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen I (veliparib, temozolomide)
    Patients receive veliparib by mouth (PO) twice a day (BID) on days 1-7 and temozolomide PO every day (QD) on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Regimen II (adavosertib, carboplatin)
    Patients receive adavosertib by mouth (PO) twice a day (BID) for 5 doses starting on day 1 and carboplatin intravenous (IV) over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Regimen III (everolimus)
    Patients receive everolimus by mouth (PO) every day (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Regimen IV (trametinib)
    Patients receive trametinib by mouth (PO) every day (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With an Objective Response [ Time Frame: Up to 30 days after completion of study treatment, up to 75 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536-
National Cancer Institute Developmental Therapeutics ClinicBethesdaMaryland20892-
Washington University School of MedicineSt LouisMissouri63110-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Aurora, CO

By research site
University of Colorado Hospital· Aurora, COEmory University Hospital/Winship Cancer Institute· Atlanta, GAUniversity of Kentucky/Markey Cancer Center· Lexington, KYNational Cancer Institute Developmental Therapeutics Clinic· Bethesda, MDWashington University School of Medicine· St Louis, MORutgers Cancer Institute of New Jersey· New Brunswick, NJ

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