NCT01827384

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

Molecular Profiling-Based Assignment of Cancer Therapy for Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. Evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers. OUTLINE: Patients are assigned to 1 of 4 treatment regimens corresponding to one of their mutation/amplification categories. REGIMEN I: Patients receive veliparib orally (PO) twice daily (BID) on days 1-7 and temozolomide PO once daily (QD) on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. REGIMEN II: Patients receive adavosertib PO BID for 5 doses starting on day 1 and carboplatin intravenously (IV) over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. (No longer an active study drug as of March 2018) REGIMEN III: Patients receive everolimus PO every day (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (No longer an active study drug as of March 2018) REGIMEN IV: Patients receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (No longer an active study drug as of March 2018) After completion of study treatment, patients are followed up for 30 days. Patients with unacceptable toxicities that have not resolved by day 30 are followed up biweekly until stabilization or resolution.

Conditions

• Advanced Malignant Solid Neoplasm

Interventions

Type	Name	Description
DRUG	Adavosertib	Given by mouth (PO)
DRUG	Carboplatin	Given intravenous (IV)
DRUG	Everolimus	Given by mouth (PO)
DRUG	Temozolomide	Given by mouth (PO)
DRUG	Trametinib	Given by mouth (PO)
DRUG	Veliparib	Given by mouth (PO)

Timeline

• Start date: 2014-01-07
• Primary completion: 2021-06-19
• Completion: 2021-10-08
• First posted: 2013-04-09
• Last updated: 2023-09-29
• Results posted: 2022-05-10

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study