NCT01480154

Akt Inhibitor MK2206 and Hydroxychloroquine in Treating Patients With Advanced Solid Tumors, Melanoma, Prostate or Kidney Cancer

A Phase I Trial of MK-2206 and Hydroxychloroquine in Solid Tumors, Melanoma, Renal and Prostate Cancer to Examine the Role of Autophagy in Tumorigenesis

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and the best dose of Akt inhibitor MK2206 together with hydroxychloroquine in treating patients with advanced solid tumors, melanoma, prostate or kidney cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as hydroxychloroquine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Akt inhibitor MK2206 together with hydroxychloroquine may kill more tumor cells than giving either drug alone.

Detailed description

PRIMARY OBJECTIVES: I. To define the maximum tolerated dose (MTD) of MK-2206 (Akt inhibitor MK2206) and hydroxychloroquine (HCQ) when used in combination. SECONDARY OBJECTIVES: I. To determine side effects and activity of MK-2206 and hydroxychloroquine when used in combination. II. To determine if hydroxychloroquine alters the pharmacokinetics of MK-2206 due to a drug-drug interaction. III. To validate biomarkers for autophagy detection. OUTLINE: This is a dose-escalation study of Akt inhibitor MK-2206. Patients receive Akt inhibitor MK2206 orally (PO) on days 1, 8, and 15. Beginning on cycle 2, patients also receive hydroxychloroquine PO twice daily (BID) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.

Conditions

• Advanced Malignant Solid Neoplasm
• Stage III Cutaneous Melanoma AJCC v7
• Stage III Prostate Cancer AJCC v7
• Stage III Renal Cell Cancer AJCC v7
• Stage IIIA Cutaneous Melanoma AJCC v7
• Stage IIIB Cutaneous Melanoma AJCC v7
• Stage IIIC Cutaneous Melanoma AJCC v7
• Stage IV Cutaneous Melanoma AJCC v6 and v7
• Stage IV Prostate Cancer AJCC v7
• Stage IV Renal Cell Cancer AJCC v7

Interventions

Type	Name	Description
DRUG	Akt Inhibitor MK2206	Given PO
DRUG	Hydroxychloroquine	Given PO

Timeline

• Start date: 2011-11-23
• Primary completion: 2020-02-14
• Completion: 2027-03-31
• First posted: 2011-11-28
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States