Status:
UNKNOWN
A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors
Lead Sponsor:
Petra Pharma
Conditions:
Breast Cancer
Endometrial Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 advanc...
Detailed Description
This study aims to test the hypothesis that controlling the glucose/insulin feedback will enhance the efficacy of PI3K inhibition in treating solid tumors. The treatment consists of serabelisib, a PI3...
Eligibility Criteria
Inclusion
- Have histologically or cytologically confirmed locally advanced or metastatic solid tumors.
- Have a tumor harboring a mutation in PIK3CA or KRAS genes.
- Have received prior therapy and have recurrent or persistent disease without standard therapies available, or are ineligible to receive standard therapies.
- Have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Have Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤2
- Have adequate organ function.
- Have adequate birth control during the course of the study.
- 12\. Are able to receive canagliflozin
Exclusion
- Diagnosis of primary brain tumor
- Untreated brain metastasis or history of leptomeningeal disease
- Have received prior chemotherapy within 28 days or other anticancer agents within 28 days of 5 half lives (whichever is the shorter duration) before the first administration of study drug. The exception is patients in Cohort 4 (PIK3CA-mutated breast cancer) are allowed to receive ongoing endocrine therapy.
- Have diabetes mellitus requiring insulin therapy
- Have diabetes mellitus requiring insulin secretagogue therapy
- Have poorly controlled diabetes mellitus defined as glycosylated hemoglobin A1c (HbA1c) \>7.5%
- Have a secondary malignancy requiring therapy or are unstable without therapy.
- Known impaired cardiac function or clinically significant cardiac disease.
- Myocardial infarction or unstable angina within 6 months before the first administration of study drug.
- Pregnant (positive serum pregnancy test) or breastfeeding
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04073680
Start Date
September 1 2020
End Date
December 30 2021
Last Update
May 21 2020
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