CLINICAL TRIALS PROFILE FOR RIPRETINIB
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All Clinical Trials for RIPRETINIB
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02571036 ↗ | A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies | Active, not recruiting | Deciphera Pharmaceuticals LLC | Phase 1 | 2015-10-01 | This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of DCC-2618, administered orally (PO), in adult patients with advanced malignancies. The study consists of 2 parts, a dose-escalation phase, and an expansion phase. All active patients (from both dose-escalation and expansion phases) will then transition into an extension phase. |
| NCT03353753 ↗ | Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies | Active, not recruiting | Deciphera Pharmaceuticals LLC | Phase 3 | 2018-02-27 | This is a 2-arm, randomized, placebo-controlled, double-blind, international, multicenter study comparing the efficacy of ripretinib (DCC-2618) to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients were randomized in a 2:1 ratio to ripretinib 150 mg QD or placebo |
| NCT03673501 ↗ | A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib | Active, not recruiting | Deciphera Pharmaceuticals LLC | Phase 3 | 2019-02-11 | This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off). |
| NCT04282980 ↗ | A Study of DCC-2618 (Ripretinib) Evaluating Efficacy, Safety, and Pharmacokinetics In Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Active, not recruiting | Zai Lab (Shanghai) Co., Ltd. | Phase 2 | 2020-04-23 | The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review.This study will enroll approximately 35 subjects in up to 10 sites in China mainland, and all subjects will be receiving DCC-2618 after enrollment as treatment. |
| NCT04530981 ↗ | A Drug-Drug Interaction Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate in Patients With Advanced GIST | Recruiting | Deciphera Pharmaceuticals LLC | Phase 1 | 2021-09-01 | Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Substrate |
| NCT04633122 ↗ | A Study to Assess the Efficacy and Safety of DCC-2618 and Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib | Recruiting | Zai Lab (Shanghai) Co., Ltd. | Phase 2 | 2020-11-25 | the primary objective of this study is to assess the efficacy (progression-free survival,PFS) of DCC-2618 (ripretinib, ZL-2307) and sunitinib in patients with advanced gastrointestinal stromal tumors after treatment with imatinib. This study will enroll approximately 98 subjects in around 18 sites in China mainland, and all subjects will be receiving DCC-2618 or Sunitinib in equal chance as treatment. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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