A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDeciphera Pharmaceuticals, LLC
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any participant with histologically or cytologically confirmed advanced/unresectable or metastatic GIST with documented KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation, who has progressed on or was intolerant to at least 1 approved tyrosine kinase inhibitor (TKI) regimen in the advanced/metastatic setting
Have at least 1 measurable lesion as defined by mRECIST, v1.1
Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
Adequate organ function, bone marrow function, and electrolytes
Disqualifiers
Received systemic anticancer therapy or radiotherapy within 14 days prior to first dose of study drug
Prior or concurrent malignancy that requires treatment or is expected to require treatment for active cancer
Has known active central nervous system (CNS) metastases or an active primary CNS cancer
History or presence of clinically relevant cardiovascular abnormalities
Trial design
Design model
Single group
Treatments tested in this trial
DCC-3009
DrugAdministered orally
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: DCC-3009 Module AExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation)
DLTs assessed for each dose level.
Time frame
Cycle 1 (28 Days)2
Objective Response Rate (ORR) (Part 2 Expansion)
ORR is the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST), v1.1.
Time frame
Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)Secondary outcomes
1
Objective Response Rate (ORR) (Part 1 Escalation)
ORR is the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) based on mRECIST, v1.1.
Time frame
Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)2
Duration of Response (DOR)
DOR for participants with confirmed CR or confirmed PR based on mRECIST, v1.1, defined as the time interval from the time that the measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that the disease progression is objectively documented or death, whichever occurs first.
Time frame
First Recorded CR or PR until PD or Death (Estimated up to 24 months)3
Progression-Free Survival (PFS)
PFS is the time from initiation of treatment until documented disease progression per mRECIST, v1.1, or death, whichever occurs first.
Time frame
Initiation of Treatment to PD or Death (Estimated up to 24 months)4
Overall Survival (OS)
OS is the time from initiation of treatment to the date of death from any cause.
Time frame
Initiation of Treatment to Death from Any Cause (Estimated up to 24 months)Sponsors and contacts
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Source ClinicalTrials.gov