Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST

Arog Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: GIST With D842V Mutated PDGFRA Gene

Treatments: Drug: Crenolanib; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02847429

ARO-012

2015-000287-34 (EudraCT Number)

Details and patient eligibility

About

This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral crenolanib versus oral placebo in combination with best supportive care in subjects with advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120 subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching placebo orally (PO) 3 times daily (TID) in combination with best supportive care.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically or cytologically-confirmed advanced or metastatic GIST with a D842V mutation in the PDGFRA gene as determined by central laboratory testing

2. Measurable disease as per modified RECIST 1.1

   • A lesion in an area that was previously treated with local therapy (e.g. radiation, surgery, or cryotherapy) can be considered measurable disease as long as there is objective evidence of progression of the lesion prior to randomization

3. Subjects (male or female) ≥ 18 years of age

4. Female subjects with reproductive potential must have negative serum or urine pregnancy test

5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Exclusion criteria

1. Severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis)
2. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
3. Female subject who is pregnant or breastfeeding, or planning to become pregnant within 30 days after ending treatment
4. Systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents) or investigational device within 3 weeks or 5 half-lives (if the drug's half-life in subject is known) prior to randomization, whichever is shorter

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Crenolanib Arm

Experimental group

Description:

Investigational product (crenolanib)

Treatment:

Drug: Crenolanib

Placebo Arm

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo