A Drug-drug Interaction Study of Avapritinib and Midazolam

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Observational Registry Data on GIST Patients DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST) Unifying Advanced Treatment With Advanced Imaging Current Management of Gastrointestinal Stromal Tumors (GIST) in the Region of Coquimbo Imatinib Mesylate in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumor Sarcopenia in Patients With Gastrointestinal Stromal Tumours Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST) Symptom Inventory for Gastrointestinal Stromal Tumors A Randomised Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST) A Study to Evaluate the Safety of Intuvax Administered Intra-tumorally in Patients With Gastrointestinal Stromal Tumors Gastrointestinal Stromal Tumors (GIST) Registry Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study 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Brief Title

A Drug-drug Interaction Study of Avapritinib and Midazolam

Official Title

A Drug-drug Interaction Study to Investigate the Effect of Avapritinib on the Pharmacokinetics of Midazolam in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)

Brief Summary

      A Drug-drug Interaction Study to Investigate the Effect of Avapritinib on the
      Pharmacokinetics of Midazolam in Patients with Unresectable or Metastatic Gastrointestinal
      Stromal Tumors (GIST)
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

maximum plasma concentration (Cmax) of midazolam

Secondary Outcome

 Number of adverse events (AEs), serious AEs (SAEs),

Condition

Gastrointestinal Stromal Tumors

Intervention

Avapritinib

Study Arms / Comparison Groups

 Patients with metastatic, unresectable GIST
Description:  Patients will receive 5 mg of midazolam orally on Day 1 and Day 18. Patients will receive avapritinib 300 mg, orally on Day 3 through Day 19.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

July 2021

Completion Date

June 2023

Primary Completion Date

May 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Must be ≥18 years of age at the time of signing the informed consent

          2. Must have histologically confirmed metastatic or unresectable GIST that has recurred
             or progressed after at least 4 lines of prior systemic SOC therapy or the Investigator
             has determined that treatment with SOC therapy is not appropriate for patients who
             failed at least 2 lines of prior SOC

          3. Patient's tumor must have known KIT mutation

          4. Must be able to swallow an oral medication

          5. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

          6. Patient agrees to use contraception consistent with local regulations

          7. Must provide signed informed consent to participate in the study

        Exclusion Criteria:

          1. Patient's tumor has known PDGFRA mutation

          2. Known hypersensitivity to avapritinib, midazolam, or any of their excipients

          3. Have received previous therapy with avapritinib

          4. Have any of the following laboratory abnormalities before the first dose of study
             drug:

               -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >3 × upper
                  limit of normal (ULN) if no hepatic metastases are present; >5 × ULN if hepatic
                  metastases are present

               -  Total bilirubin >1.5 × ULN; >3 × ULN in the presence of Gilbert's Disease

               -  Estimated (Cockcroft-Gault formula) or measured creatinine clearance <60 mL/min

               -  Platelet count <90 × 109/L

               -  Absolute neutrophil count (ANC) <1.0 × 109/L

               -  Hemoglobin <9 g/dL. Transfusion and erythropoietin may be used to reach at least
                  9 g/dL but must have been administered at least 2 weeks before the first dose of
                  the study drug.

          5. Require therapy with a concomitant medication that is a strong and moderate CYP3A4
             inhibitors or inducers

          6. Consumption of any nutrients known to modulate CYP3A4 enzymes activity (eg, grapefruit
             or grapefruit juice, pomelo juice, star fruit, or Seville [blood] orange and
             derivative products, cruciferous vegetables [eg, broccoli, cauliflower, cabbage,
             brussel sprouts]) within 14 days before screening and during the study until the end
             of the Main Treatment Period

          7. Have received a prior anticancer drug less than 5 half-lives or 14 days (whichever is
             shorter) before screening

          8. Have had a major surgical procedure within 14 days of the first dose of study drug or
             have significant traumatic injury within 28 days before screening

          9. Have history of a seizure disorder (eg, epilepsy) or requirement for anticonvulsant
             medications

         10. Have history of a cerebrovascular accident or transient ischemic attacks within 1 year
             before screening

         11. Have known risk of intracranial bleeding, such as a brain aneurysm or history of
             subdural or subarachnoid bleeding

         12. Have primary brain malignancy or metastases to the brain

         13. Have corrected QT interval using Fridericia's formula (QTcF) >450 msec

         14. Have clinically significant, uncontrolled, cardiovascular disease, including
             congestive heart failure Grades 2, 3, or 4 according to the New York Heart Association
             classification, myocardial infarction, or unstable angina within the previous 6
             months, or uncontrolled hypertension

         15. Have experienced any hemorrhage or bleeding event National Cancer Institute Common
             Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade ≥3 within 4
             weeks before screening

         16. Patients who have a symptomatic nonhealing wound, ulcer, GI perforation, or bone
             fracture

         17. Have received organ or allogenic bone marrow or peripheral blood stem cell transplant

         18. Have known diagnosis of human immunodeficiency virus infection or active viral
             hepatitis; viral testing is not required

         19. History of alcohol consumption exceeding 2 standard drinks per day on average (1
             standard drink = 14 grams of alcohol). Alcohol consumption will be prohibited 48 hours
             before screening and throughout the entire the Main Treatment Period

         20. Use of tobacco- or nicotine-containing products within 3 months of enrollment

         21. Is a female patient who is unwilling, if not postmenopausal or surgically sterile, to
             abstain from sexual intercourse or employ highly effective contraception from the time
             of informed consent and for until at least 6 months after the last dose of study drug.
             Males who are unwilling, if not surgically sterile, to abstain from sexual intercourse
             or employ highly effective contraception from the time of informed consent and for at
             least 90 days after the last dose of study drug.

         22. Is a female patient who is pregnant, as documented by a serum beta human chorionic
             gonadotropin (β-hCG) pregnancy test consistent with pregnancy obtained within 7 days
             before the first dose of study drug. Patients with β-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
             nonchildbearing potential (postmenopausal for more than 12 months, bilateral tubal
             ligation, bilateral oophorectomy, or hysterectomy) do not require a serum β-hCG test.

         23. Female who is breastfeeding

         24. Have a prior or ongoing clinically significant illness, medical condition, surgical
             history, physical finding, or laboratory abnormality that, in the Investigator's
             opinion, could affect the safety of the patient, alter the absorption, distribution,
             metabolism or excretion of the study drugs, or impair the assessment of study results.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 617-714-6707, [email protected]



Administrative Informations


NCT ID

NCT04908176

Organization ID

BLU-285-1107


Responsible Party

Sponsor

Study Sponsor

Blueprint Medicines Corporation


Study Sponsor

, , 


Verification Date

May 2021