DCC-3009 for GIST

Recruiting at 8 trial locations

Overseen By Clinical Team

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Deciphera Pharmaceuticals, LLC

Must not be taking: Systemic anticancer, Radiotherapy

Disqualifiers: CNS metastases, Cardiovascular abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this Phase 1/2 master protocol study is to evaluate if DCC-3009 is safe, tolerable and works effectively in the treatment of GIST. The study will use a modular approach with each module being defined according to therapy: DCC-3009 alone or DCC-3009 in combination with other anticancer therapies. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). Participants will be treated in 28-day treatment cycles with an estimated duration of up to 2 years.

Will I have to stop taking my current medications?

The trial requires that you have not received any systemic anticancer therapy or radiotherapy within 14 days before starting the study drug. It does not specify about other medications, so you should discuss your current medications with the trial team.

Who Is on the Research Team?

Clinical Team

Principal Investigator

Deciphera Pharmaceuticals, LLC

Are You a Good Fit for This Trial?

This trial is for people with advanced or metastatic GIST who've had a previous treatment fail. They should have a life expectancy over 3 months, at least one measurable tumor, be relatively active (ECOG PS of 0 or 1), and have good organ and bone marrow function.

Inclusion Criteria

Have at least 1 measurable lesion as defined by mRECIST, v1.1

All participants agree to comply with the contraception requirements

Have a life expectancy of more than 3 months

Exclusion Criteria

Known allergy or hypersensitivity to any component of the study drug

I have significant heart problems.

Any other clinically significant comorbidities

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DCC-3009 in 28-day cycles, including Part 1 (Dose Escalation) and Part 2 (Dose Expansion)

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DCC-3009

Trial Overview DCC-3009's safety and effectiveness are being tested in patients with GIST. The study has two parts: finding the right dose and then expanding that dose to more patients. It involves cycles of treatment lasting up to two years.

How Is the Trial Designed?

Group I: DCC-3009 Module A Experimental Treatment 1 Intervention

Participants will receive DCC-3009 in 28 day cycles in Module A Part 1 dose escalation and Part 2 dose expansion.

Who Is Running the Clinical Trial?

Deciphera Pharmaceuticals, LLC

Lead Sponsor

Trials

19

Recruited

2,100+