Gastrointestinal Stromal Tumors

Oncology
15
Pipeline Programs
11
Companies
15
Clinical Trials
1 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
4
2
5
0
2
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
8100%
+ 8 programs with unclassified modality

On Market (1)

Approved therapies currently available

Blueprint Medicines
AYVAKITApproved
avapritinib
Blueprint Medicines
Kinase Inhibitor [EPC]oral2020

Competitive Landscape

11 companies ranked by most advanced pipeline stage

Blueprint Medicines
Blueprint MedicinesMA - Cambridge
3 programs
1
1
1
AvapritinibPhase 4Small Molecule1 trial
CS3007Phase 1/21 trial
AvapritinibPhase 1Small Molecule1 trial
Active Trials
NCT04908176Completed10Est. May 2024
NCT04254939Completed65Est. Apr 2023
NCT04825574Completed2Est. Nov 2023
AS
AB ScienceFrance - Paris
2 programs
2
MasitinibPhase 3Small Molecule1 trial
MasitinibPhase 3Small Molecule1 trial
Active Trials
NCT00812240TerminatedEst. Jul 2018
NCT01694277CompletedEst. Dec 2020
Cogent Biosciences
2 programs
1
1
Bezuclastinib in combination with sunitinibPhase 2Small Molecule1 trial
CGT9486Phase 1/21 trial
Active Trials
NCT02401815Completed51Est. May 2020
NCT06208748Active Not Recruiting40Est. Jun 2027
Alliance Pharmaceuticals
2 programs
2
Bezuclastinib in combination with sunitinibPhase 2Small Molecule
PazopanibPhase 2Small Molecule1 trial
Active Trials
NCT02342600Withdrawn0
Zai Lab
Zai LabCA - South SF
1 program
1
DCC-2618Phase 21 trial
Active Trials
NCT04282980Completed39Est. Aug 2022
Pfizer
PfizerNEW YORK, NY
1 program
1
SU011248Phase 21 trial
Active Trials
NCT00137449Completed60Est. Apr 2008
DS
Daiichi SankyoChina - Shanghai
1 program
1
DS-6157aPhase 11 trial
Active Trials
NCT04276415Terminated34Est. Mar 2022
NN
Novelty NobilityKorea - Seongnam
1 program
1
NN3201Phase 11 trial
Active Trials
NCT06805825Recruiting67Est. Dec 2027
CT
1 program
1
Sunitinib malate capsules generic productPhase 11 trial
Active Trials
NCT05800106CompletedEst. Jan 2019
Novartis
NovartisBASEL, Switzerland
1 program
GIST RegistryN/A1 trial
Active Trials
NCT00507273Completed1,800Est. Dec 2010
Bayer
BayerLEVERKUSEN, Germany
1 program
RegorafenibN/ASmall Molecule1 trial
Active Trials
NCT01646593No Longer Available

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Blueprint MedicinesAvapritinib
AB ScienceMasitinib
AB ScienceMasitinib
Cogent BiosciencesBezuclastinib in combination with sunitinib
Zai LabDCC-2618
Alliance PharmaceuticalsPazopanib
PfizerSU011248
Blueprint MedicinesCS3007
Cogent BiosciencesCGT9486
Novelty NobilityNN3201
Blueprint MedicinesAvapritinib
Daiichi SankyoDS-6157a
Chia Tai TianQing Pharmaceutical GroupSunitinib malate capsules generic product
NovartisGIST Registry

Clinical Trials (15)

Total enrollment: 2,168 patients across 15 trials

NCT04825574Blueprint MedicinesAvapritinib

Study for Patients Previously Treated in Avapritinib Clinical Trials

Start: May 2021Est. completion: Nov 20232 patients
Phase 4Completed
NCT01694277AB ScienceMasitinib

Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

Start: Apr 2012Est. completion: Dec 2020
Phase 3Completed
NCT00812240AB ScienceMasitinib

Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Start: Jan 2009Est. completion: Jul 2018
Phase 3Terminated
NCT06208748Cogent BiosciencesBezuclastinib in combination with sunitinib

SARC044: A Phase II Trial of Bezuclastinib in Combination With Sunitinib in Patients With GIST

Start: Aug 2024Est. completion: Jun 202740 patients
Phase 2Active Not Recruiting
NCT04282980Zai LabDCC-2618

A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)

Start: Apr 2020Est. completion: Aug 202239 patients
Phase 2Completed
NCT02342600Alliance PharmaceuticalsPazopanib

SARC029: Trametinib and Pazopanib in Patients With GIST (Gastrointestinal Stromal Tumor)

Start: Jan 20170
Phase 2Withdrawn
NCT00137449PfizerSU011248

Study Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor

Start: Sep 2005Est. completion: Apr 200860 patients
Phase 2Completed
NCT04254939Blueprint MedicinesCS3007

A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor

Start: Aug 2019Est. completion: Apr 202365 patients
Phase 1/2Completed
NCT02401815Cogent BiosciencesCGT9486

CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors

Start: Mar 2015Est. completion: May 202051 patients
Phase 1/2Completed
NCT06805825Novelty NobilityNN3201

A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Express c-Kit

Start: Feb 2025Est. completion: Dec 202767 patients
Phase 1Recruiting
NCT04908176Blueprint MedicinesAvapritinib

A Drug-drug Interaction Study of Avapritinib and Midazolam

Start: Aug 2022Est. completion: May 202410 patients
Phase 1Completed
NCT04276415Daiichi SankyoDS-6157a

DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST)

Start: May 2020Est. completion: Mar 202234 patients
Phase 1Terminated
NCT05800106Chia Tai TianQing Pharmaceutical GroupSunitinib malate capsules generic product

A Bioequivalence Study of Sunitinib Malate Capsules.

Start: Dec 2018Est. completion: Jan 2019
Phase 1Completed
NCT01646593BayerRegorafenib

Regorafenib in Subjects With Gastrointestinal Stromal Tumors (GIST) Who Have Progressed After Standard Therapy

N/ANo Longer Available
NCT00507273NovartisGIST Registry

Gastrointestinal Stromal Tumors (GIST) Registry

Start: Aug 2005Est. completion: Dec 20101,800 patients
N/ACompleted

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 2,168 patients
11 companies competing in this space

Related Indications

Breast Cancer(530)Non-small Cell Lung Cancer(373)Prostate Cancer(371)Multiple Myeloma(244)Advanced Solid Tumors(221)Acute Myeloid Leukemia(204)Cancer(187)Neoplasms(173)Colorectal Cancer(166)Advanced Solid Tumor(165)