Selumetinib and Cyclosporine in Treating Patients With Advanced Solid Tumors or Advanced or Metastatic Colorectal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 46
Summary
- Conditions
- Recurrent Colorectal Carcinoma
- Solid Neoplasm
- Stage IIIA Colorectal Cancer AJCC v7
- Stage IIIB Colorectal Cancer AJCC v7
- Stage IIIC Colorectal Cancer AJCC v7
- Stage IVA Colorectal Cancer AJCC v7
- Stage IVB Colorectal 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 determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combination of AZD6244 (selumetinib) and cyclosporin A (cyclosporine) in adult patients with advanced solid tumors. SECONDARY OBJECTIVES: I. To determine the safety profile and tolerability o...
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combination of AZD6244 (selumetinib) and cyclosporin A (cyclosporine) in adult patients with advanced solid tumors. SECONDARY OBJECTIVES: I. To determine the safety profile and tolerability of this regimen in this patient population. II. To determine the pharmacokinetics of the combination. III. To evaluate the selected biomarkers of drug effect in patients with advanced solid tumors or refractory metastatic colorectal cancer (CRC). IV. Evaluate the activity of the combination in terms of objective response rate (per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1), progression-free survival (PFS). OUTLINE: This is a phase I, dose-escalation study of selumetinib followed by a phase Ib study. Patients receive selumetinib orally (PO) twice daily (BID) on day -7 of course 1 and then on days 1-28 (one dose on day 1 only). Patients also receive cyclosporine PO BID on day -3 of course 1 and then on days 1-28 (one dose on day 1 only). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Tracking Information
- NCT #
- NCT02188264
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Christopher H Lieu University of Texas MD Anderson Cancer Center LAO