GIST - Gastrointestinal Stromal TumorPhase 1NCT04530981
A Drug-Drug Interaction Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate in Patients with Advanced GIST
A Phase 1 study testing Ripretinib and Repaglinide in people with GIST - Gastrointestinal Stromal Tumor, run by Deciphera Pharmaceuticals, LLC at 3 sites in United States.
Trial summary
Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Substrate Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GIST - Gastrointestinal Stromal Tumor
- What is being tested?
- Ripretinib and Repaglinide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Sep 2021to 29 Jul 2024
- Phase
- Phase 1
- 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
- Patients ≥18 years of age.
- Patients must have a histologic diagnosis of GIST.
- Patients must have GIST that has progressed on or have intolerance to at least 2 lines of prior TKI therapies.
- Patients must have an Eastern Cooperative Oncology Group performance score of ≤ 2.
- If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements.
- Adequate organ and bone marrow function.
Who cannot join
- Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose.
- Prior treatment with ripretinib.
- Patients who have had prior repaglinide treatment within 14 days prior to Cycle 1 Day 1.
- History or presence of clinically relevant cardiovascular abnormalities.
- Gastrointestinal abnormalities including but not limited to:
- inability to take oral medication,
Show all 9Show fewer
- malabsorption syndromes,
- requirement for intravenous alimentation.
- Patients who have type 1 or type 2 diabetes.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic Florida
Jacksonville, Florida, 32224
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: A Phase 1 Open-label, Multicenter Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate (Repaglinide) in Patients with Advanced Gastrointestinal Stromal Tumors (GIST)
Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Substrate
- Conditions
- GIST - Gastrointestinal Stromal Tumor
- Being tested
- Ripretinib, Repaglinide
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RipretinibDrug
Also called QINLOCK
Oral KIT/PDGFRA kinase inhibitor
RepaglinideDrug
Oral antihyperglycemic agent
| Study group | Role | What they receive |
|---|---|---|
| Repaglinide 0.5 mg + Ripretinib 150 mg QD | Experimental | A single dose of repaglinide 0.5 mg (1 × 0.5-mg tablet) will be administered orally on Cycle 1 Day 1 and Cycle 1 Day 15. Ripretinib 150 mg QD (3 × 50-mg tablets) will be administered orally from Day 2 through Day 28 for Cycle 1 and will be administered continuously from Cycle 2 until disease progression as assessed by the Investigator, unacceptable toxicity, or withdrawal of consent. Receives: Drug: Ripretinib; Drug: Repaglinide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration for Repaglinide
Measure the Cmax
Measured: Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
Area under the concentration-time curve (AUC) from time 0 up to time t (AUC0-t) for Repaglinide
Measure the AUC0-t
Measured: Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
AUC from time 0 and extrapolated to infinity (AUC0-∞)
Measure the AUC0-∞
Measured: Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
Secondary outcomes (1)
Incidence of Adverse Events
Adverse events [TEAEs, SAEs], dose reduction, dose interruption, or discontinuation, vital signs (heart rate [beats/min], and changes in laboratory parameters (chemistry, hematology, urinalysis, coagulation).
Measured: Cycle 1 through study completion (~ 12 months). Each cycle is 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start22 Sep 2021
- Primary completion16 Nov 2023
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GIST - Gastrointestinal Stromal TumorStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deciphera Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530981
- Sponsor's protocol ID
- DCC-2618-01-007
- Status last verified
- Sep 2024
- First submitted
- 24 Aug 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label, Multicenter Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate (Repaglinide) in Patients with Advanced Gastrointestinal Stromal Tumors (GIST)
- ClinicalTrials.gov ID
- NCT04530981
- Acronym / sponsor ID
- DCC-2618-01-007
- Conditions
- GIST - Gastrointestinal Stromal Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Deciphera Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 28 Aug 2020 (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.
Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Substrate
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Repaglinide 0.5 mg + Ripretinib 150 mg QD | Experimental | Drug: Ripretinib, Drug: RepaglinideA single dose of repaglinide 0.5 mg (1 × 0.5-mg tablet) will be administered orally on Cycle 1 Day 1 and Cycle 1 Day 15. Ripretinib 150 mg QD (3 × 50-mg tablets) will be administered orally from Day 2 through Day 28 for Cycle 1 and will be administered continuously from Cycle 2 until disease progression as assessed by the Investigator, unacceptable toxicity, or withdrawal of consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients ≥18 years of age.
- Patients must have a histologic diagnosis of GIST.
- Patients must have GIST that has progressed on or have intolerance to at least 2 lines of prior TKI therapies.
- Patients must have an Eastern Cooperative Oncology Group performance score of ≤ 2.
- If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements.
Key exclusion criteria (9 listed)
- Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose.
- Prior treatment with ripretinib.
- Patients who have had prior repaglinide treatment within 14 days prior to Cycle 1 Day 1.
- History or presence of clinically relevant cardiovascular abnormalities.
- Gastrointestinal abnormalities including but not limited to:
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 |
|---|---|---|
| RipretinibAlso: QINLOCKOral KIT/PDGFRA kinase inhibitor | Drug | Repaglinide 0.5 mg + Ripretinib 150 mg QD |
| RepaglinideOral antihyperglycemic agent | Drug | Repaglinide 0.5 mg + Ripretinib 150 mg QD |
Primary outcome
Maximum Observed Plasma Concentration for Repaglinide
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
Measure the Cmax
Area under the concentration-time curve (AUC) from time 0 up to time t (AUC0-t) for Repaglinide
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
Measure the AUC0-t
AUC from time 0 and extrapolated to infinity (AUC0-∞)
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
Measure the AUC0-∞
1 secondary outcome
Incidence of Adverse Events
Time frame: Cycle 1 through study completion (~ 12 months). Each cycle is 28 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ripretinib and Repaglinide in people with GIST - Gastrointestinal Stromal Tumor, run by Deciphera Pharmaceuticals, LLC at 3 sites in United States.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration for Repaglinide (time frame: Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.). The study lists 3 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 19 Sep 2024.