A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors
1 other identifier
interventional
60
0 countries
N/A
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 advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 breast-cancer
Started Sep 2020
Shorter than P25 for phase_1 breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2019
CompletedFirst Posted
Study publicly available on registry
August 29, 2019
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedMay 21, 2020
May 1, 2020
11 months
August 26, 2019
May 20, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Rate of Adverse Events
Safety of serabelisib in combination with canagliflozin as evaluated by incidence of drug-related adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities.
30 days after last dose
Rate of Laboratory Abnormalities
Safety of serabelisib in combination with canagliflozin as evaluated by incidence of clinical laboratory abnormalities
30 days after last dose
Dose confirmation
To confirm the appropriate dose of serabelisib to be coadministered with canagliflozin
6 months
Tumor Assessments by RESIST
To assess efficacy of serabelisib in combination with canagliflozin in patients with solid tumors with PIK3CA or KRAS mutations
2 years
Secondary Outcomes (3)
Cmax Pharmacokinetic assessment
Day 1 and 8 of Cycle 1: pre-dose and then post-dose at 1.5 hours, 3 hours, 6 hours, 9 hours, 12 hours, and 24 hours
Tmax Pharmacokinetic assessment
Day 1 and 8 of Cycle 1: pre-dose and then post-dose at 1.5 hours, 3 hours, 6 hours, 9 hours, 12 hours, and 24 hours
AUC Pharmacokinetic assessment
Day 1 and 8 of Cycle 1: pre-dose and then post-dose at 1.5 hours, 3 hours, 6 hours, 9 hours, 12 hours, and 24 hours
Study Arms (1)
Serabelisib
EXPERIMENTALPart 1 is dose escalation of Serabelisib Cohort 1 = 600mg; Cohort 2 = 900mg; Cohort 3 = 1200mg Part 2 is expansion of mutational cohorts with selected dose as follows: Cohort 4 = PIK3CA-mutated breast cancer; Cohort 5 = PIK3CA-mutated Non breast cancer; Cohort 6 = KRAS mutated
Interventions
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
All subjects will be dosed with 300 mg canagliflozin in combination with serabelisib
Eligibility Criteria
You may qualify if:
- 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.
- \. Are able to receive canagliflozin
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Petra Pharmalead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Albert Yu, MD
Petra Pharma
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2019
First Posted
August 29, 2019
Study Start
September 1, 2020
Primary Completion
July 15, 2021
Study Completion
December 30, 2021
Last Updated
May 21, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share