NCT03158103 is a Phase 1 clinical trial of MEK162 in Gastrointestinal Stromal Tumor (GIST), sponsored by Memorial Sloan Kettering Cancer Center.

Who is sponsoring NCT03158103?

NCT03158103 is sponsored by Memorial Sloan Kettering Cancer Center.

What drugs are being tested in NCT03158103?

Interventions in NCT03158103: MEK162, Pexidartinib.

What condition does NCT03158103 study?

NCT03158103 studies Gastrointestinal Stromal Tumor (GIST).

Is NCT03158103 still recruiting?

NCT03158103 is currently completed. Last updated 30 April 2021.

Last reviewed 2021-04-30 · How we verify

NCT03158103

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of MEK162 (Binimetinib) in Combination With Pexidartinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

Completed Phase 1 Last updated 30 April 2021

What this trial tests

Phase 1 trial testing MEK162 in Gastrointestinal Stromal Tumor (GIST) in 3 participants. Completed in 28 April 2021.

Timeline

15 April 2017

Primary endpoint
28 April 2021

28 April 2021

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	15 April 2017
Primary completion	28 April 2021
Estimated completion	28 April 2021
Sites	1 location across United States

Drugs / interventions tested

MEK162 (mek162) — full drug profile →
Pexidartinib — full drug profile →

Conditions studied

Gastrointestinal Stromal Tumor (GIST) — all drugs for Gastrointestinal Stromal Tumor (GIST) →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Gastrointestinal Stromal Tumor (GIST). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to test the safety and tolerability of the combination of pexidartinib and MEK162. This study tests different doses of pexidartinib in combination with different doses of MEK162 to see which dose combination of these drugs is safe and best tolerated in people.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting Tumor Microenvironment for Cancer Therapy.
Roma-Rodrigues C, Mendes R, Baptista PV, Fernandes AR. · · 2019 · cited 865× · PMID 30781344 · DOI 10.3390/ijms20040840
Targeting macrophages in cancer immunotherapy.
Duan Z, Luo Y. · · 2021 · cited 462× · PMID 33767177 · DOI 10.1038/s41392-021-00506-6
Tumor microenvironment signaling and therapeutics in cancer progression.
Goenka A, Khan F, Verma B, Sinha P, et al · · 2023 · cited 203× · PMID 37005490 · DOI 10.1002/cac2.12416
Tissue macrophages: origin, heterogenity, biological functions, diseases and therapeutic targets.
Guan F, Wang R, Yi Z, Luo P, et al · · 2025 · cited 155× · PMID 40055311 · DOI 10.1038/s41392-025-02124-y
Pexidartinib: First Approval.
Lamb YN. · · 2019 · cited 155× · PMID 31602563 · DOI 10.1007/s40265-019-01210-0
Pexidartinib, a Novel Small Molecule CSF-1R Inhibitor in Use for Tenosynovial Giant Cell Tumor: A Systematic Review of Pre-Clinical and Clinical Development.
Benner B, Good L, Quiroga D, Schultz TE, et al · · 2020 · cited 138× · PMID 32440095 · DOI 10.2147/dddt.s253232
CSF1R inhibitors are emerging immunotherapeutic drugs for cancer treatment.
Wen J, Wang S, Guo R, Liu D. · · 2023 · cited 115× · PMID 36335744 · DOI 10.1016/j.ejmech.2022.114884
Small-molecule agents for cancer immunotherapy.
Wang F, Fu K, Wang Y, Pan C, et al · · 2024 · cited 41× · PMID 38486980 · DOI 10.1016/j.apsb.2023.12.010

Verify or expand the search:

Other trials of MEK162

Trials testing the same drug.

NCT02631447 — Sequential Combo Immuno and Target Therapy (SECOMBIT) Study · Phase 2 · completed
NCT02285439 — Study of MEK162 for Children With Low-Grade Gliomas · Phase 1, PHASE2 · completed
NCT02276027 — A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advance · Phase 2 · completed
NCT02159066 — LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma · Phase 2 · completed
NCT01859026 — A Phase I/IB Trial of MEK162 in Combination With Erlotinib in NSCLC Harboring KRAS or EGFR Mutation · Phase 1 · completed

Other recruiting trials for Gastrointestinal Stromal Tumor (GIST)

Currently open trials in the same condition.

NCT07072143 — An International Study on Pediatric Patients With Rare Tumors. · recruiting
NCT05489237 — First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors · Phase 1 · recruiting
NCT04557969 — Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis · recruiting

Other Memorial Sloan Kettering Cancer Center trials

Trials by the same sponsor.

NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT07507643 — A Study of Methylprednisolone in People Having Liver Surgery · Phase 3 · recruiting
NCT07483307 — A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer · Phase 2 · recruiting
NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term · Phase 2 · recruiting
NCT07449195 — A Study Comparing Two Optical Coherence Tomography Devices in People With Ocular Tumors · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03158103 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center
Last refreshed: 30 April 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03158103.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing