Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Neoplasm Metastasis

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

All Drugs and Chemicals

Antineoplastic Agents

Tin Fluorides

Sunitinib

Growth Inhibitors

Angiogenesis Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Participants will receive both CGT9486 and sunitinib orally until study stopping rules are met.

CGT9486 plus sunitinib

Participants will receive CGT9486 until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.

CGT9486

Participants will receive sunitinib until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.

Participants will receive sunitinib orally until study stopping rules are met.

Cogent Biosciences

Jessica Sachs, MD

This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 426 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner.

This is a multi-part study: Part 1a is a single-arm design, Part 1b is a two-arm parallel design drug-drug interaction evaluation in the first treatment cycle and single-arm design in subsequent treatment cycles, and Part 2 is a randomized two-arm parallel comparator study

(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors

Area under the plasma concentration-time curve (AUC)

Time to maximum observed plasma concentration (Tmax)

Time from first dose to documented disease progression or death due to any cause, whichever occurs first

Incidence and severity of Adverse Events from first dose of study drug

Incidence and severity of Serious Adverse Events from first dose of study drug

Incidence of Adverse Events leading to dose modifications from first dose of study drug

Change from baseline in laboratory results

Time from first dose to death due to any cause

Percentage of subjects who achieved documented complete response (CR) + confirmed partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Percentage of subjects who achieved CR + PR + stable disease (SD) at 16 weeks

Time from first dose to first documented response based on modified Response Evaluation Criteria in Solid Tumors Version 1.1

Time from first response (CR or PR) to the date of progression or death from any cause, whichever occurs first

Change in individual scores in patients with locally advanced, unresectable, or metastatic GIST treated with CGT9486 in combination with sunitinib compared with patients treated with sunitinib monotherapy. The scale comprises 30 questions, 24 of which are aggregated into 9 multi-item scales, to include 5 functioning scales (physical, role, cognitive, emotional and social), 3 symptom scales (fatigue, pain and nausea/vomiting) and 1 global health status scale. The remaining 6 single-item scales assess symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea and the financial impact). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning, while higher scores on the symptom and single-item scales indicate a higher level of symptoms.

Spots Global Cancer Trial Database for cgt9486 plus sunitinib