Clinical Trial Extension Study with Avapritinib for Patients with Gastrointestinal Stromal Tumors
- Conditions
- ocally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)MedDRA version: 21.1Level: PTClassification code 10051066Term: Gastrointestinal stromal tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-005751-21-FR
- Lead Sponsor
- Blueprint Medicines
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 5
1. Patient has histologically confirmed metastatic or unresectable GIST as established by entry in a previous avapritinib clinical trial and has been receiving treatment with avapritinib on one of these trials.
2. Patient continues to receive clinical benefit from avapritinib treatment, as assessed by the investigator.
3. Patient or legal guardian, if permitted by local regulatory authorities, provides informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3
1. Patient requires therapy with a concomitant medication that is a strong inhibitor or strong inducer of cytochrome P450 (CYP) 3A4.
2. Patient has a history of intracranial bleeding either prior to or during avapritinib treatment
3. Patients who have poor organ function, defined as Adverse Events of NCI CTCAE version 5.0 Grade 3 or higher at the time of enrollment must delay start of treatment until symptoms return to Grade 2 or baseline, or the start of treatment has been approved by the Sponsor.
4. Patients who have ongoing cognitive or mood effects Adverse Events of NCI CTCAE version 5.0 higher than Grade 1 must delay start of treatment until symptoms return to Grade 1 or baseline.
5. Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of enrollment and for at least 30 days after the last dose of avapritinib. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of first dose and for at least 90 days after the last dose of avapritinib.
6. Women who are pregnant, as documented by a serum beta human chorionic gonadotropin (ß-hCG) pregnancy test consistent with pregnancy, obtained within 7 days before the enrollment. Females with ß-hCG values that are within the range for pregnancy but are not pregnant (false-positives) may be enrolled with written consent of the Sponsor, after pregnancy has been ruled out. Females of non-childbearing potential (postmenopausal for more than 1 year; bilateral tubal ligation; bilateral oophorectomy; hysterectomy) do not require a serum ß-hCG test.
7. Women who are breast feeding.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To provide long term safety data for GIST patients who are deriving clinical benefit from avapritinib on an existing avapritinib clinical trial<br>- To further characterize the rate of SAEs and AESIs of avapritinib.;Secondary Objective: Not applicable;Primary end point(s): This is an open-label extension study to provide long term safety data for GIST patients who are deriving clinical benefit from avapritinib on an existing clinical trial that has met its primary endpoints;Timepoint(s) of evaluation of this end point: Disease response assessments should be performed per standard of care.<br>SAEs, AESIs and concomitant medications are to be collected from the date of the informed consent signature through end of treatment.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable