GIST - Gastrointestinal Stromal TumorNCT04148092
Expanded Access Program of Ripretinib (DCC-2618) for the Treatment of Patients With Advanced GIST
A study testing ripretinib in people with GIST - Gastrointestinal Stromal Tumor, run by Deciphera Pharmaceuticals, LLC.
Trial summary
This is an open-label, single-arm, multicenter expanded access study to provide patients who have locally advanced unresectable or metastatic gastrointestinal stromal tumor (GIST) and have received treatment with at least 2 prior Food and Drug Administration (FDA)-approved therapies early access to ripretinib until… 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
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Male or female patients, ≥ 18 years of age at the time of informed consent
- Histologic diagnosis of GIST
- Patients must have received prior treatment with at least 2 of the FDA-approved drugs for GIST: imatinib, sunitinib, and regorafenib.
- Female patients of childbearing potential must have a negative pregnancy test at Screening.
- Patients of reproductive potential must agree to follow the contraception requirements.
- Patient is capable of understanding and complying with the protocol and has signed the ICF. A signed ICF must be obtained before any study specific procedures are performed.
- Adequate organ function and bone marrow reserve as determined by the Investigator at Screening.
- Resolution to Grade 1 or baseline of all serious toxicities from prior therapy prior to initiating treatment with ripretinib
Who cannot join
- Eligible to participate in another ongoing clinical study in which the patient may have access to ripretinib
- Received treatment with anticancer therapy, including investigational therapy, or investigational procedures within 7 days or 5 × the half-life (whichever is longer) prior to the first dose of ripretinib. For prior biological therapies (eg, monoclonal antibodies with a half-life longer than 3 days), the interval must be at least 28 days prior to the first dose of ripretinib.
- Received prior treatment with ripretinib
- Known active central nervous system metastases
- With a concurrent malignancy for which treatment is being received that may interfere with the potential benefits of ripretinib to the patient
- Undergone major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of ripretinib. Following major surgeries, > 4 weeks prior to the first dose of ripretinib, all surgical wounds must be healed and free of infection or dehiscence.
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- Any other clinically significant comorbidities which in the judgment of the Investigator, could predispose the patient to safety risks
- Known human immunodeficiency virus or hepatitis C infection only if the patient is taking medications that must be avoided or taken with caution per protocol, active hepatitis B, or active hepatitis C infection
- If female, the patient is pregnant or lactating.
- Known allergy or hypersensitivity to any component of the investigational product. Patients with a history of Stevens-Johnson syndrome on a prior tyrosine kinase inhibitor are excluded.
- Gastrointestinal abnormalities including but not limited to:
- inability to take oral medication
- malabsorption syndromes
- requirement for intravenous alimentation
- Any active bleeding excluding hemorrhoidal or gum bleeding
About this study
Official title: Expanded Access Program for Ripretinib in Patients With Locally Advanced Unresectable or Metastatic GIST Who Have Received Treatment With Prior Therapies
This is an open-label, single-arm, multicenter expanded access study to provide patients who have locally advanced unresectable or metastatic gastrointestinal stromal tumor (GIST) and have received treatment with at least 2 prior Food and Drug Administration (FDA)-approved therapies early access to ripretinib until such time that ripretinib becomes commercially available or the Sponsor chooses to discontinue the program.
Read the detailed description
The EAP is no longer enrolling patients in the United States.
- Conditions
- GIST - Gastrointestinal Stromal Tumor
- Being tested
- ripretinib
- 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 DCC-2618
orally administered solid dosage form
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
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.
- More trials run by Deciphera Pharmaceuticals, LLCThe sponsor's other registered studies.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Deciphera Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148092
- Sponsor's protocol ID
- DCC-2618-99-001
- Status last verified
- May 2020
- First submitted
- 30 Oct 2019
- Last updated
- 29 May 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program for Ripretinib in Patients With Locally Advanced Unresectable or Metastatic GIST Who Have Received Treatment With Prior Therapies
- ClinicalTrials.gov ID
- NCT04148092
- Acronym / sponsor ID
- DCC-2618-99-001
- Conditions
- GIST - Gastrointestinal Stromal Tumor
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Deciphera Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- First posted
- 1 Nov 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 is an open-label, single-arm, multicenter expanded access study to provide patients who have locally advanced unresectable or metastatic gastrointestinal stromal tumor (GIST) and have received treatment with at least 2 prior Food and Drug Administration (FDA)-approved therapies early access to ripretinib until such time that ripretinib becomes commercially available or the Sponsor chooses to discontinue the program.
Detailed description
The EAP is no longer enrolling patients in the United States.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients, ≥ 18 years of age at the time of informed consent
- Histologic diagnosis of GIST
- Patients must have received prior treatment with at least 2 of the FDA-approved drugs for GIST: imatinib, sunitinib, and regorafenib.
- Female patients of childbearing potential must have a negative pregnancy test at Screening.
- Patients of reproductive potential must agree to follow the contraception requirements.
Key exclusion criteria (15 listed)
- Eligible to participate in another ongoing clinical study in which the patient may have access to ripretinib
- Received treatment with anticancer therapy, including investigational therapy, or investigational procedures within 7 days or 5 × the half-life (whichever is longer) prior to the first dose of ripretinib. For prior biological therapies (eg, monoclonal antibodies with a half-life longer than 3 days), the interval must be at least 28 days prior to the first dose of ripretinib.
- Received prior treatment with ripretinib
- Known active central nervous system metastases
- With a concurrent malignancy for which treatment is being received that may interfere with the potential benefits of ripretinib to the patient
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: DCC-2618orally administered solid dosage form | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Ripretinib EAP WebpageLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing ripretinib in people with GIST - Gastrointestinal Stromal Tumor, run by Deciphera Pharmaceuticals, LLC.
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 15 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 29 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 29 May 2020.