(NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors

Completed · Phase 1

Conditions studied: Gastrointestinal Stromal Tumors (GIST), Other Relapsed or Refractory Solid Tumors

In brief

This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of avapritinib (formerly BLU-285), administered orally (PO), in adult patients with unresectable GIST or other relapsed or refractory solid tumors. The study consists of 2 parts, a dose-escalation part (Part 1) and an expansion part (Part 2).

Key facts

Study ID

NCT02508532

Run by

Blueprint Medicines Corporation

People needed

250

Starts

2015-08-01

Expected to finish

2021-06-03

Last updated by the study team

2022-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For Part 1: Histologically- or cytologically-confirmed diagnosis of unresectable GIST or another advanced solid tumor. Patients with unresectable GIST must have disease that has progressed following imatinib and at least 1 of the following: sunitinib, regorafenib, sorafenib, dasatinib, pazopanib or an experimental kinase-inhibitor agent, or disease with a D842 mutation in the PDGFRα gene. Patients with an advanced solid tumor other than GIST must have relapsed or refractory disease without an available effective therapy.
• OR For Part 2:
• Group 1: Patients must have a confirmed diagnosis of unresectable GIST that has progressed following imatinib and at least 1 of the following: sunitinib, regorafenib, sorafenib, dasatinib, pazopanib, or an experimental kinase-inhibitor agent, and the patient does not have a D842V mutation in PDGFRα.
• Group 2: Patients must have a confirmed diagnosis of unresectable GIST with a D842V mutation in the PDGFRα gene. The PDGFRα mutation will be identified by local or central assessment, either in an archival tissue sample or a new tumor biopsy obtained prior to treatment with avapritinib.
• Group 3: Patients must have a confirmed diagnosis of unresectable GIST that has progressed and/or patients must have experienced intolerance to imatinib and not received additional kinase-inhibitor therapy. Patients must not have a known D842V mutation in PDGFRα.
• Groups 1, 2 and 3: At least 1 measurable lesion defined by mRECIST 1.1 for patients with GIST.
• Groups 1 and 2: A tumor sample (archival tissue or a new tumor biopsy) has been submitted for mutational testing.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

You may not qualify if…

• QT interval corrected using Fridericia's formula (QTcF) >450 milliseconds
• Platelet count <90,000/mL
• Absolute neutrophil count <1000/mL
• Hemoglobin <9 g/dL
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 x the 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 with direct bilirubin, >1.5 × ULN in the presence of Gilbert's Disease
• Estimated (Cockroft-Gault formula) or measured creatinine clearance <40 mL/min Brain malignancy or metastases to the brain
• History of a seizure disorder or requirement for anti-seizure medication
• Group 3: Patients known to be KIT wild type.

Where it is running

• Scottsdale Healthcare Hospitals DBA HonorHealth — Scottsdale, Arizona, United States
• Sarcoma Oncology Center — Santa Monica, California, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Cancer Treatment Centers of America — Atlanta, Georgia, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Leuven Cancer Institute University Hospitals Leuven — Leuven, Belgium
• Centre Leon Berard — Lyon, France
• Institut Gustave Roussy — Paris, France
• University of Duisburg-Essen — Essen, Germany
• Fondazione IRCCS - Istituto Nazinale dei Tumori — Milan, Italy
• Erasmus MC Cancer Institute — Rotterdam, Netherlands
• Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie w Warszawie — Warsaw, Poland
• Asan Medical Center — Seoul, South Korea
• Vall d' Hebron Institute of Oncology (VHIO) — Barcelona, Spain
• Royal Marsden Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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