A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04073680|
Recruitment Status : Unknown
Verified May 2020 by Petra Pharma.
Recruitment status was: Not yet recruiting
First Posted : August 29, 2019
Last Update Posted : May 21, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Endometrial Cancer Lung Cancer Colo-rectal Cancer Head and Neck Cancer||Drug: Serabelisib Drug: Canagliflozin 300mg||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors With PIK3CA or KRAS Mutations|
|Estimated Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||July 15, 2021|
|Estimated Study Completion Date :||December 30, 2021|
Part 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
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
Other Name: Invokana
- Rate of Adverse Events [ Time Frame: 30 days after last dose ]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.
- Rate of Laboratory Abnormalities [ Time Frame: 30 days after last dose ]Safety of serabelisib in combination with canagliflozin as evaluated by incidence of clinical laboratory abnormalities
- Dose confirmation [ Time Frame: 6 months ]To confirm the appropriate dose of serabelisib to be coadministered with canagliflozin
- Tumor Assessments by RESIST [ Time Frame: 2 years ]To assess efficacy of serabelisib in combination with canagliflozin in patients with solid tumors with PIK3CA or KRAS mutations
- Cmax Pharmacokinetic assessment [ Time Frame: 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 ]Maximum observed plasma concentration (Cmax) of serabelisib
- Tmax Pharmacokinetic assessment [ Time Frame: 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 ]Time of maximum observed plasma concentration (Tmax) of serabelisib
- AUC Pharmacokinetic assessment [ Time Frame: 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 ]Area under the plasma concentration time curve in the dosing interval AUC of serabelisib
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073680
|Contact: Albert Yu, MDemail@example.com|
|Contact: Peggy Siemon-Hryczyk, MSfirstname.lastname@example.org|
|Study Director:||Albert Yu, MD||Petra Pharma|
|Responsible Party:||Petra Pharma|
|Other Study ID Numbers:||
|First Posted:||August 29, 2019 Key Record Dates|
|Last Update Posted:||May 21, 2020|
|Last Verified:||May 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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