Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST)

Related Clinical Trial
Ripretinib Used for Resectable Metastatic GIST After Failure of Imatinib Therapy Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST) Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten) 68Ga-NOTA-RM26 PET/CT for the Detection of Gastrointestinal Stromal Tumor Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors A Drug-drug Interaction Study of Avapritinib and Midazolam Study for Patients Previously Treated in Avapritinib Clinical Trials Oncogenetic Panel and Integrated Clinical Data Registration Study for Wild Type Gastrointestinal Stromal Tumor Patients Gastrointestinal Anastomosis Using MonoPlus® Suture NIR Fluorescence Imaging With ICG for the Intraoperative Identification of Gastrointestinal Stromal Cell Tumours DNX-2440 for Resectable Colorectal Liver Metastasis EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors A Study to Assess the Efficacy and Safety of DCC-2618 and Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib Testing the Anti-cancer Drug, Rogaratinib (BAY 1163877), for Treatment of Advanced Sarcoma With Alteration in Fibroblast Growth Factor Receptor (FGFR 1-4), and in Patients With SDH-deficient Gastrointestinal Stromal Tumor (GIST) Study in Low Risk Gastrointestinal Stromal Tumor (GISTs) Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics Preventing Viral Pandemic Associated Risk of Cancer Death Using Less Invasive Diagnostic Tests- Liquid Biopsies A Drug-Drug Interaction Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate in Patients With Advanced GIST Efficacy and Safety of Famitini Versus Sunitinib in the Treatment of Advanced Gastrointestinal Stromal Tumour Patients After Failure of Imatinib Collection of Biospecimen & Clinical Information in Patients w/ Gastrointestinal Cancers Vaccine Therapy in Treating Patients With Metastatic Solid Tumors Quick Skin Sealant in Closure of Surgical Wound After Laparoscopic Surgery Permission to Collect Blood Over Time for Research A Clinical Trial With a New Needle Device Comparing Two Needles for EUS_FNA of Solid Lesions. Ipilimumab and Imatinib Mesylate in Advanced Cancer Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors EUS-guided Fine Needle Biopsy With a New Core Histology Needle Versus Conventional Fine Needle Aspiration Ph II of Capecitabine, Carboplatin & Bevacizumab for Gastroesophageal Junction & Gastric Carcinoma Perifosine + Sunitinib Malate for Patients With Advanced Cancers Advanced Gastrointestinal Endoscopic Imaging Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies The Oncopanel Pilot (TOP) Study Evaluation of a New EUS-guided Needle (ProCore) Comparing to EUS-TCB Needle (Quick-Core) Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle The Effects of Preoperative and Postoperative Oral Nutritional Supplements in Malnourished Post-gastrectomy Patients A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors Cytochrom p450 3A4 and 1A2 Phenotyping for the Individualization of Treatment With Sunitinib or Erlotinib in Cancer Patients Doxorubicin Hydrochloride and Alvocidib in Treating Patients With Metastatic or Recurrent Sarcoma That Cannot Be Removed By Surgery Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST) Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects Study of the Immunoresponse in Patients Treated With a Tyrosine Kinase Inhibitor Nilotinib Roll-over Protocol for Patients in Novartis-sponsored Nilotinib Study and Benefiting From Nilotinib Treatment SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas Impact of the Inhibitors of Tyrosine Kinase on the Male Fertility Evaluation of Cognitive Function of Patients With Sunitinib or Sorafenib A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I) Caphosol in Oral Mucositis Due to Targeted Therapy EUS-FNB vs. Single-incision Needle-knife (SINK) Biopsy for Gastrointestinal SELs Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene To Compare the Efficacy of Surgery Followed by Sunitinib With Surgery Followed by Imatinib in GIST Patients With Progression on Imatinib. Prospective Database of Gastrointestinal Stromal Cell Tumors (GISTs) Long Term Effects of Tyrosine Kinase Inhibitor Therapy on Ovarian Reserve and Fertility in Patients With Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumor Study on the Influence of Sunitinib and Sorafenib on Fatigue, QoL, Depression in Patients With Metastatic RCC or GIST CCI-779 in Treating Patients With Soft Tissue Sarcoma or Gastrointestinal Stromal Tumor Early Access Program (EAP) for Avapritinib in Patients With Locally Advanced Unresectable or Metastatic GIST Distress, Medication Adherence and Care Needs in Patients With CML and GIST Receiving Oral Targeted Therapy Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination The Effects of the Proton Pump Inhibitor Esomeprazole on the Bioavailability of Regorafenib Long-term Surival of GIST Patients ≥ 10 Years on Imatinib Influence of an Acidic Beverage on the Imatinib Exposure After Major Gastrectomy Chromosome Abnormalities in Chronic Myeloid Leukemia (CML) on Imatinib. GIST Patients on Imatinib Trial of Tasigna (Nilotinib) 400 mg Twice Daily Alone or With Gleevec (Imatinib Mesylate) 400 mg Daily for Patients With Advanced Gastrointestinal Stromal Tumor (GIST) A Study of HQP1351 in Patients With GIST or Other Solid Tumors PDR001 Plus Imatinib for Metastatic or Unresectable GIST Laparoscopic Resection of Large Gastric Stromal Tumors Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies Imatinib Dose Escalation to 800 mg/Day in Korean Patients With Metastatic or Unresectable GIST Harboring KIT Exon 9 Mutation: KENEDI Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR] Single Agent Regorafenib in First-line for Metastatic/Unresectable KIT/PDGFR Wild Type GIST Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan). Expanded Access Program of Ripretinib (DCC-2618) for the Treatment of Patients With Advanced GIST Efficiency of Imatinib Treatment Maintenance or Interruption After 3 Years of Adjuvant Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib Salvage Surgery for Patients With Metastatic GIST With Rego Non-Interventional Retrospective Correlation Of Tumor Mutational Status To Clinical Benefit Of GIST Patients Treated With Sunitinib Selinexor in Combination With Imatinib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors. Patients Completing Core Protocol (CAMN107A2103), Exhibiting Stable Disease (SD), Partial Response (PR) or Complete Response (CR) to Nilotinib in Combination With Imatinib A Retrospective Clinical Records Review of Patients Diagnosed With Gastrointestinal Stromal Tumour at Two Tertiary Institutes in Singapore A Study to Investigate the Safety and Efficacy of AT13387, Alone or in Combination With Imatinib, in Patients With GIST PLX9486 as a Single Agent and in Combination With PLX3397 or PLX9486 With Sunitinib in Patients With Advanced Solid Tumors Clinical Outcome of Female Non-gastric Gastrointestinal Stromal Tumor A Retrospective Pharmacokinetics and Pharmacogenomics Research of Imatinib in Gastrointestinal Stromal Tumor Treatment Comparative Bioequivalence Study in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions Dasatinib and Ipilimumab in Treating Patients With Gastrointestinal Stromal Tumors or Other Sarcomas That Cannot Be Removed by Surgery or Are Metastatic Dovitinib in Combination With Imatinib in Patients With Gastrointestinal Stromal Tumors Epacadostat and Pembrolizumab in Patients With GIST Efficacy of Pazopanib in Gastrointestinal Stromal Tumors (GIST) MITIGATE-NeoBOM: A Study to Evaluate 68Ga- NeoBOMB1 in Patients With Advanced TKI-treated GIST Using PET/CT Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients Prospective Cohort Study of the Clinical Applications for the Pathologic Type, Staging, and Grading of GIST Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor A Study of Avelumab In Combination With Axitinib in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumor After Failure of Standard Therapy An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST) Prospective Multicentric Randomized Study of Glivec® in Advanced GIST Expressing C-kit: Interruption After 5 Years vs Maintenance Ph II CABOGIST in GIST Expanded Access to Everolimus, for an Individual Patient With GIST (Gastrointestinal Stromal Tumors)(CTMS#18-0019) Sorafenib for Imatinib/Sunitinib-failed GIST A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor Regorafenib in GIST With Secondary C-KIT Exon 17 Mutation Paclitaxel in Patients With GIST With Low P-glycoprotein Expression After Failure of at Least Imatinib and Sunitinib, and Regorafenib. Study Evaluating IPI-504 in Patients With Gastrointestinal Stromal Tumors (GIST) Following Failure of at Least Imatinib and Sunitinib A Study of MEK162 (Binimetinib) in Combination With Pexidartinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST) Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study) Rechallenge of Imatinib in GIST Having no Effective Treatment: RIGHT Treatment of Patients With Everolimus and Imatinib Mesylate Who Have Progressive Gastro Intestinal Stromal Tumors (GIST) and Are Resistant to Imatinib Mesylate Multicentre Placebo-controlled Double-blinded Phase II Study of Lenvatinib Efficacy in Patients With Locally Advanced or Metastatic GIST (Gastrointestinal Stromal Tumor) After Imatinib/Sunitinib Failure Regorafenib Post-marketing Surveillance in Japan A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST) Oblimersen and Imatinib Mesylate in Treating Patients With Advanced Gastrointestinal Stromal Tumors That Cannot Be Removed By Surgery A Clinical Trial Evaluating the Efficacy and Safety of Dasatinib in Refractory Metastatic GIST (VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST Imatinib Mesylate With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor Nilotinib in Advanced Gastrointestinal Stromal Tumors (GIST) A Study of BBI503 in Adult Patients With Advanced Gastrointestinal Stromal Tumors Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate (NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors Regorafenib in Subjects With Gastrointestinal Stromal Tumors (GIST) Who Have Progressed After Standard Therapy Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors BGJ398 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST) Study of Imatinib and Peginterferon α-2b in Gastrointestinal Stromal Tumor (GIST) Patients A Study of Nilotinib Versus Imatinib in GIST Patients Nilotinib Pharmacokinetics (PK) in Gastrointestinal Stromal Tumor (GIST): Nilotinib PK Paclitaxel in Patients With Metastatic or Advanced Gastrointestinal Stromal Tumors (GIST) After Failure to Imatinib and Sunitinib Nivolumab With or Without Ipilimumab in Treating Patients With Gastrointestinal Stromal Tumor That Is Metastatic or Cannot Be Removed by Surgery Efficacy and Safety of Anlotinib in Patients With Advanced Gastrointestinal Stromal Tumor After Failure of Imatinib: a Prospective, Single Arm and Multicenter Trial Study Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib. Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST) Regorafenib in Subjects With Gastrointestinal Stromal Tumors (GIST) Who Have Progressed After Standard Therapy (Managed Access Program) A Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to Imatinib and/or Sunitinib A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST) Entacapone Combination With Imatinib for Treatment of GIST Masitinib in Patients With Localized, Primary GIST After Complete Surgery and With High Risk of Recurrence Dovitinib for Imatinib/Sumitinib-failed Gastrointestinal Stromal Tumors (GIST): TKI258 Management of Imatinib-associated Severe Skin Rash in Patients With Gastrointestinal Stromal Tumor Nilotinib 800 Mg And Imatinib 800 Mg For The Treatment Of Patients With Gastrointestinal Stromal Tumors (Gist) Refractory To Imatinib 400 Mg Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib Adjuvant Imatinib in High-risk Gastrointestinal Stromal Tumor (GIST) With C-kit Mutation Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor Temozolomide (TMZ) In Advanced Succinate Dehydrogenase (SDH)-Mutant/Deficient Gastrointestinal Stromal Tumor (GIST) SSG XXV: The Stop-GIST Trial; Discontinuation of Imatinib in Patients With Oligo-metastatic GIST Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST) L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors Study of Hsp90 Inhibitor AUY922 for the Treatment of Patients With Refractory Gastrointestinal Stromal Tumor Gleevec Administered Preoperatively to Reduce Gastrointestinal Stromal Tumor (GIST) Efficacy and Safety of Dovitinib in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib SARC029: Trametinib and Pazopanib in Patients With GIST (Gastrointestinal Stromal Tumor) Phase II Study of Regorafenib Continuous Dosing of Regorafenib in Patients With GISTs A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST) Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib A Study of Intermittent Dosing Schedule of Imatinib in Patients With Tyrosine Kinase Inhibitor Refractory GISTs Treatment Patterns in Gastrointestinal Stromal Tumors in the Community Oncology Setting Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib A Prospective, Multicenter Study on Best Clinical Use of Imatinib in the Advanced Gastrointestinal Stromal Tumors Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor Everolimus in Combination With Imatinib in Patients With Glivec Refractory/Resistant Gastrointestinal Stromal Tumors Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST) Masitinib in Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST) Phase II Study Aiming to Evaluate the Efficacy and Safety of Nilotinib Patients With Gastrointestinal Stromal Tumors (GIST) Resistant or Intolerant to Imatinib and or to 2nd Line Tyrosine Kinas (TK) Inhibitor MEK162 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST) Surgery for Locally Unresectable Advanced GISTs Without Metastasis After Imatinib Therapy Imatinib Mesylate in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed By Surgery Preoperative and Postoperative Imatinib Mesylate Study in Patients With c-Kit Positive GIST Phase Ib Study of SUnitinib Alternating With REgorafenib in Patients With Metastatic and/or Unresectable GIST Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST) A Study of Olaratumab (IMC-3G3) in Previously Treated Participants With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors Circulating Cell-free Tumor DNA in the Plasma of Patients With Gastrointestinal Stromal Tumors (GIST) A Study of AUY922 for GIST(Gastrointestinal Stromal Tumor) Patients Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor Detection of CF-DNA in Patients With Gastrointestinal Stromal Tumors (GIST) Long Outcome of Endoscopic Submucosal Dissection for Small Gastrointestinal Stromal Tumors ( Ph II Study of Perifosine Plus Gleevec for Patients With GIST Pazopanib in Imatinib Refractory or Intolerant Gastrointestinal Stromal Tumors (GIST) Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor Efficacy of Imatinib in Patients With Intermediate-risk Gastrointestinal Stromal Tumor With a High-risk Genomic Grade Index Serum Dickkopf-4 as a Biomarker for the Diagnosis and Treatment of Gastrointestinal Stromal Tumor Imatinib Mesylate and Sunitinib in Treating Patients With Gastrointestinal Stromal Tumors Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST) Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors A Study of DCC-2618 (Ripretinib) Evaluating Efficacy, Safety, and Pharmacokinetics In Patients With Advanced Gastrointestinal Stromal Tumors (GIST) S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line With Nilotinib A Study of Famitinib in Patients With Gastrointestinal Stromal Tumor Open-label Trial of GlivecWith Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors Imatinib Mesylate With or Without Surgery in Treating Patients With Metastatic Gastrointestinal Stromal Tumor That is Responding to Imatinib Mesylate Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal Tumors Role of Surgery in Patients With Focally Progressive Gastrointestinal Stromal Tumors (GISTs) After Imatinib Treatment WB-DWI for Early Prediction of Therapy Response in Patients With Advanced Metastatic GIST Treated With Regorafenib Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST) Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor Study of Tumor Samples in Patients Undergoing Treatment for Gastrointestinal Stromal Tumors on Clinical Trial ACOSOG-Z9001 Observational Registry Data on GIST Patients DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST) Unifying Advanced Treatment With Advanced Imaging Current Management of Gastrointestinal Stromal Tumors (GIST) in the Region of Coquimbo Imatinib Mesylate in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumor Sarcopenia in Patients With Gastrointestinal Stromal Tumours Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST) Symptom Inventory for Gastrointestinal Stromal Tumors A Randomised Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST) A Study to Evaluate the Safety of Intuvax Administered Intra-tumorally in Patients With Gastrointestinal Stromal Tumors Gastrointestinal Stromal Tumors (GIST) Registry Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor

Brief Title

Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST)

Official Title

A Phase 1b/2, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST)

Brief Summary

      Multicenter, open-label Phase 1b/2 study of ripretinib in combination with binimetinib in
      patients with gastrointestinal stromal tumor (GIST). There will be 2 distinct parts in this
      study: Dose Escalation (Phase 1) and Expansion (Phase 2).
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Safety/tolerability of oral ripretinib in combination with binimetinib: incidence of adverse events

Secondary Outcome

 Determine the time to maximum observed concentration (tmax) profile of oral ripretinib in combination with binimetinib

Condition

Gastrointestinal Stromal Tumors

Intervention

Ripretinib

Study Arms / Comparison Groups

 Escalation
Description:  Escalation Phase: Increasing doses of ripretinib in combination with increase doses of binimetinib in patients with advanced GIST who have progressed on at least imatinib or are intolerant to imatinib and are ripretinib naïve in repeated 28-day cycles.
Participants may remain on treatment until disease progression, unacceptable toxicity, or withdrawal of consent

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

93

Start Date

November 2021

Completion Date

May 2027

Primary Completion Date

November 2025

Eligibility Criteria

        Inclusion Criteria:

          1. Patients ≥18 years of age with advanced GIST (unresectable or metastatic).

          2. Must have at least progressed on imatinib or have documented intolerance to imatinib.

          3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status
             (PS) of 0 or 1.

          4. Patients must have a histologic diagnosis of GIST.

          5. If a female of childbearing potential, must have a negative pregnancy test.

          6. Adequate organ function and bone marrow function

        Exclusion Criteria:

          1. Received prior anticancer therapy within 14 days or 5× the half-life whichever is
             longer) prior to the first dose.

          2. Ongoing or prior participation in the DCC-2618-03-002 study.

          3. Prior therapy with ripretinib.

          4. Prior therapy with MEK inhibitor.

          5. History of certain ocular disorders.

          6. History of clinically significant hepatobiliary disease.

          7. Known active central nervous system metastases.

          8. History or presence of clinically relevant cardiovascular abnormalities.

          9. Systemic arterial or venous thrombotic or embolic events within 6 months of first
             dose.

         10. History of acute or chronic pancreatitis

         11. History of chronic inflammatory bowel disease or Crohn's disease requiring
             intervention within 12 months of first dose.

         12. Gastrointestinal abnormalities including but not limited to:

               -  inability to take oral medication,

               -  malabsorption syndromes
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 785-830-2100, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT05080621

Organization ID

DCC-2618-01-008


Responsible Party

Sponsor

Study Sponsor

Deciphera Pharmaceuticals LLC


Study Sponsor

, , 


Verification Date

October 2021