Combining pimitespib with imatinib for treating gastrointestinal stromal tumors
A Phase 1 Study of TAS-116 (Pimitespib) in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumor
This study is testing if combining the drugs pimitespib and imatinib can help people with gastrointestinal stromal tumors who haven't improved with imatinib alone.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Taiho Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | imatinib, sunitinib |
| Locations | 14 sites (Adelaide and 13 other locations) |
| Trial ID | NCT05245968 on ClinicalTrials.gov |
What this trial studies
This study investigates the combination of pimitespib and imatinib in patients with gastrointestinal stromal tumors (GIST) who have not responded to imatinib alone. It consists of a dose escalation phase to determine the maximum tolerated dose and an expansion phase with three arms to evaluate the efficacy and safety of the combination therapy, pimitespib monotherapy, and sunitinib as a reference. The study aims to assess safety, pharmacokinetics, and antitumor effects in this patient population.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed GIST who have shown radiographic progression after imatinib treatment.
Not a fit: Patients who have undergone total gastrectomy or have received other lines of therapy for advanced GIST may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with GIST who are refractory to standard imatinib therapy.
How similar studies have performed: While this approach is novel in combining these specific therapies, similar studies have shown promise in targeting GIST with alternative treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provided written informed consent * Histologically confirmed GIST * Has radiographic progression based on RECIST 1.1 during or within 6 months of the last imatinib administration at enrollment. If surgery/radiotherapy has been performed, radiographic progression based on RECIST 1.1 with imatinib must have been observed after the last surgery /radiotherapy * Has at least one measurable lesion based on the RECIST version 1.1, except lymph nodes (not dependent on size), which should be chosen as nontarget lesions; * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Exclusion Criteria: * Corrected visual acuity \< 0.5 (using the International Visual Acuity Measurement Standard) for both eyes * Received treatment with any other line of therapy besides imatinib for advanced GIST * History of total gastrectomy and/or whole resection of the small intestine * A serious illness or medical condition * Previous or concurrent cancer that is distinct in primary disease or histology from cancer that is being evaluated in this study. However, any previous cancer curatively treated \> 5 years before the enrollment can be eligible * Pregnancy or lactation (including lactation interruption)
Where this trial is running
Adelaide and 13 other locations
- Flinders Medical Center — Adelaide, Australia (Recruiting)
- Alfred Health — Melbourne, Australia (Recruiting)
- Beijing Cancer Hospital — Beijing, China (Recruiting)
- Fudan University, Shanghai Cancer Center — Shanghai, China (Recruiting)
- National Cancer Center Hospital East — Chiba, Japan (Recruiting)
- Hokkaido University Hospital — Hokkaido, Japan (Recruiting)
- Kumamoto University Hospital — Kumamoto, Japan (Recruiting)
- Osaka University Hospital — Osaka, Japan (Recruiting)
- National Cancer Center Hospital — Tokyo, Japan (Recruiting)
- The Cancer Institute Hospital of JFCR — Tokyo, Japan (Recruiting)
- National University Cancer Institute — Singapore, Singapore (Recruiting)
- Kaohsiung Medical University Hospital — Kaohsiung, Taiwan (Recruiting)
- Linkou Chang Gung Memorial Hospital — Linkou, Taiwan (Recruiting)
- Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Drug Information Center
- Email: n-arimura@taiho.co.jp
- Phone: +81-3-3294-4527
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.