Breast CancerPhase 1/2NCT04073680
A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors
A Phase 1/2 study testing Serabelisib and Canagliflozin 300mg in people with Breast Cancer and Endometrial Cancer, run by Petra Pharma.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Endometrial Cancer, Lung Cancer
- What is being tested?
- Serabelisib and Canagliflozin 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 30 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors With PIK3CA or KRAS Mutations
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.
Read the 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 PI3K alpha isoform (PI3Kα) inhibitor, combined with the sodium-glucose cotransporter-2 (SGLT2) inhibitor canagliflozin. The study will assess the safety and efficacy of the combination in adult patients with advanced solid tumors harboring mutations that may be dependent on PI3Kα activity: PIK3CA mutations and KRAS mutations.
- Being tested
- Serabelisib, Canagliflozin 300mg
- Medical subject headings
- Breast Neoplasms, Endometrial Neoplasms, Lung Neoplasms, Colonic Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerabelisibDrug
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
Canagliflozin 300mgDrug
Also called Invokana
All subjects will be dosed with 300 mg canagliflozin in combination with serabelisib
| Study group | Role | What they receive |
|---|---|---|
| Serabelisib | Experimental | 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 Receives: Drug: Serabelisib; Drug: Canagliflozin 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after last dose
Rate of Laboratory Abnormalities
Safety of serabelisib in combination with canagliflozin as evaluated by incidence of clinical laboratory abnormalities
Measured: 30 days after last dose
Dose confirmation
To confirm the appropriate dose of serabelisib to be coadministered with canagliflozin
Measured: 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
Measured: 2 years
Secondary outcomes (3)
Cmax Pharmacokinetic assessment
Maximum observed plasma concentration (Cmax) of serabelisib
Measured: 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
Time of maximum observed plasma concentration (Tmax) of serabelisib
Measured: 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
Area under the plasma concentration time curve in the dosing interval AUC of serabelisib
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start1 Sep 2020 (estimated)
- Primary completion15 Jul 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Petra Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Albert Yu, MD, Study director, Petra Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073680
- Sponsor's protocol ID
- PT06-01
- Status last verified
- May 2020
- First submitted
- 26 Aug 2019
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors With PIK3CA or KRAS Mutations
- ClinicalTrials.gov ID
- NCT04073680
- Acronym / sponsor ID
- PT06-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Petra PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 29 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 PI3K alpha isoform (PI3Kα) inhibitor, combined with the sodium-glucose cotransporter-2 (SGLT2) inhibitor canagliflozin. The study will assess the safety and efficacy of the combination in adult patients with advanced solid tumors harboring mutations that may be dependent on PI3Kα activity: PIK3CA mutations and KRAS mutations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serabelisib | Experimental | Drug: Serabelisib, Drug: Canagliflozin 300mgPart 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SerabelisibSubjects 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 | Serabelisib |
| Canagliflozin 300mgAlso: InvokanaAll subjects will be dosed with 300 mg canagliflozin in combination with serabelisib | Drug | Serabelisib |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Yu, MD study director
Petra Pharma
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Serabelisib and Canagliflozin 300mg in people with Breast Cancer and Endometrial Cancer, run by Petra Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Albert Yu, MD (646-440-9218, ayu@petrapharmacorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Adverse Events (time frame: 30 days after last dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.