A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors
NCT04073680 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2020-05-21
Summary
This study aims to test the hypothesis that combining serabelisib, a PI3K alpha isoform inhibitor, with an SGLT2 inhibitor, canagliflozin will improve efficacy in the treatment of patients with advanced solid tumors.
Conditions
- Breast Cancer
- Endometrial Cancer
- Lung Cancer
- Colo-rectal Cancer
- Head and Neck Cancer
Interventions
- DRUG
-
Serabelisib
Subjects will be dosed with Serabelisib on 3 consecutive days a week in a 28 day cycle until tumor progression. in combination with Canagliflozin 300mg, both are oral medications
- DRUG
-
Canagliflozin 300mg
All subjects will be dosed with 300 mg canagliflozin in combination with serabelisib
Sponsors & Collaborators
-
Petra Pharma
lead INDUSTRY
Principal Investigators
-
Albert Yu, MD · Petra Pharma
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-01
- Primary Completion
- 2021-07-15
- Completion
- 2021-12-30
- FDA Drug
- Yes
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