Akt Inhibitor MK2206 and Hydroxychloroquine in Treating Patients With Advanced Solid Tumors, Melanoma, Prostate or Kidney Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 36
Summary
- 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
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 h...
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.
Tracking Information
- NCT #
- NCT01480154
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jyoti Malhotra Rutgers Cancer Institute of New Jersey
Get Well Soon