PH 2 Pemigatinib in SDH-deficient GIST

Conditions

• Gastrointestinal Stromal Tumor
• SDH Gene Mutation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pemigatinib — DRUG
  A selective Fibroblast Growth Factor Receptors inhibitor * Tablet taken orally

Study Details

The purpose of this study is to determine how effective the drug pemigatinib is as a treatment option for advanced succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors(GIST). This study will also assess the side effects associated with pemigatinib and evaluate its tolerability. The name of the study drug involved in this study is: • Pemigatinib (INCB054828)

Key Dates

Start date

May 19, 2026

Status verified

May 2026

Primary completion

Oct 1, 2028

Completion

Apr 1, 2029

Study Design

Enrollment

24 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: PEMIGATINIB
  Pemigatinib will be taken orally 1x daily on Days 1-14, not taken days 15-21 of each 21-day study cycle (2 weeks on, 1 week off). Cycles will continue until disease progression, unacceptable toxicity, or other protocol-defined criteria

Primary Outcome Measure

Objective radiographic response rate [ Time Frame: From first dose of pemigatinib until the date of objective response per RECIST 1.1 through study completion, an average of 1 year ]

Central Contacts

• Suzanne George, MD
  617-632-5204
  [email protected]

Locations (1)

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