A Study of APG-115 in Patients With Salivary Gland Carcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Malignant Salivary Gland Cancer
- Salivary Gland Cancer
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Part 1: Arm A: APG-115 Monotherapy, APG-115 (PO): dose= 150 mg, Cycle length: 21 days Arm B: APG-115 + Carboplatin, APG-115 (PO): dose= 150 mg, Cycle length: 21 days Carboplatin (IV): dose= AUC 4.5, day= 1, cycle length: 21 days Part 2: One of the regimens in Arm A or Arm B based on emerging data from Part 1.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is an open label multi-institution phase I/II study with an initial randomized component then followed by a planned single-arm phase. Arms will be monitored using the time-to-event continual reassessment method (TITE-CRM). In the initial randomized phase, patients will be randomized to one of t...
This is an open label multi-institution phase I/II study with an initial randomized component then followed by a planned single-arm phase. Arms will be monitored using the time-to-event continual reassessment method (TITE-CRM). In the initial randomized phase, patients will be randomized to one of two arms: Arm A (APG-115 alone) or Arm B (APG-115 + Carboplatin) at a ratio of 1:2. After 14 patients have been accrued in Arm A and 28 patients have been accrued to Arm B, responses will be tabulated. The outcomes of the arms will be considered, and a single arm will be selected for further study in part 2 of the study. Response rate (defined as CR or PR after cycle 2) will be the foremost consideration for deciding on the most promising arm; in addition, a comprehensive evaluation of the available data including toxicity and pharmacokinetic (PK) data will also be considered. After an arm has been chosen to advance an additional 20 patients will be accrued.
Tracking Information
- NCT #
- NCT03781986
- Collaborators
- University of Michigan
- Investigators
- Study Chair: Yifan Zhai, MD, PhD Ascentage Pharma Group Inc.
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