Clinical trial · Interventional
Phase 2 Study in Patients With MiT Tumors
A Phase 2 Study of ARQ 197 in Patients With Microphthalmia Transcription Factor Associated Tumors
NCT00557609CI-TRIAL-00009372completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multi-center, single arm intended to evaluate the anti-tumor effect of ARQ 197 in patients with microphthalmia transcription factor associated (MiT) tumors. MiT tumors include clear cell sarcoma, alveolar soft parts sarcoma, and translocation associated renal cell carcinoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alveolar Soft Part Sarcoma (ASPS) | Alveolar Soft Part Sarcoma | ONTOLOGY_EXACT | 0.85 |
| Clear Cell Sarcoma (CCS) | Clear Cell Sarcoma of Soft Tissue | ALIAS | 0.85 |
| Renal Cell Carcinoma (RCC) | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARQ 197 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine the overall response rate (ORR) in patients treated with ARQ 197
Secondary outcomes (3)
- measure
- Evaluate progression-free survival (PFS) time in patients treated with ARQ 197
- measure
- Evaluate 6-month and 1-year overall survival (OS) rates in patients treated with ARQ 197
- measure
- Further characterize the safety of ARQ 197 in adolescent and young adult patients with MiT tumors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed unresectable locally advanced or metastatic alveolar soft part sarcoma, clear cell sarcoma, or translocation associated renal cell carcinoma 2. ≥13 years old 3. Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives or avoidance of pregnancy measures during the study and for 30 days after the last ARQ 197 dose 4. Females of childbearing potential must have a negative serum pregnancy test Exclusion Criteria: 1. Central nervous system metastasis unless it has been stable for ≥ 3 months after treatment and patient has no neural symptoms 2. Pregnant or lactating 3. Significant gastrointestinal disorder(s), in the opinion of a Investigator, could interfere with the absorption of ARQ 197 (e.g., Crohn's disease, ulcerative colitis, extensive gastric or small bowel resection) 4. Unable or unwilling to swallow ARQ 197 capsules twice daily 5. Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 6. Bradycardia at baseline or known history of arrhythmia 7. Received ARQ 197 previously
References
Publications (1)
- DERIVEDWagner AJ, Goldberg JM, Dubois SG, Choy E, Rosen L, Pappo A, Geller J, Judson I, Hogg D, Senzer N, Davis IJ, Chai F, Waghorne C, Schwartz B, Demetri GD. Tivantinib (ARQ 197), a selective inhibitor of MET, in patients with microphthalmia transcription factor-associated tumors: results of a multicenter phase 2 trial. Cancer. 2012 Dec 1;118(23):5894-902. doi: 10.1002/cncr.27582. Epub 2012 May 17. PMID 22605650