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Recruiting NCT07618377

Study of DCC-2618 in Patients With GIST After at Least 3 Prior Treatments

Phase I Interventional Gastrointestinal Stromal Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DCC-2618.
Who it may be relevant to
Registry conditions: Gastrointestinal Stromal Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1 Study to Evaluate the Safety of DCC-2618 in Patients With Unresectable, Metastatic, or Recurrent Gastrointestinal Stromal Tumor (GIST) Who Are Refractory or Intolerant to at Least 3 Prior Therapies

Overview

To evaluate the safety of DCC-2618 in patients with unresectable, metastatic, or recurrent gastrointestinal stromal tumor (GIST) who have received three or more prior therapies

Interventions

  • Drug DCC-2618
    DCC-2618 150 mg, administered orally once daily

Primary outcome measures

  • Adverse event (AE) [Time frame: Up to 2 years]

Eligibility criteria

Inclusion criteria

  • Participants with a histologically confirmed diagnosis of GIST.
  • Participants who are refractory or intolerant to treatment with at least imatinib, sunitinib, and regorafenib.
  • Participants with at least one measurable lesion per the modified Response Evaluation Criteria in Solid Tumors (mRECIST) within 28 days prior to the first administration of the investigational product.
  • Participants with an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

Exclusion criteria

  • Participants with a concomitant or prior history of severe hypersensitivity reactions to other tyrosine kinase inhibitors.
  • Participants with uncontrolled diabetes mellitus.
  • Participants with a systemic infection requiring treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Japan · 2 centers
  • National Cancer Center Hospital East — Kashiwa
  • National Cancer Center Hospital — Tokyo

Identifiers

NCT: NCT07618377 · DCC-2618-01 · jRCT2031260153

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗