Clinical trial · Interventional
TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES)
TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES). Phase II Clinical Trial, Single Arm, Two Stage
NCT02608411CI-TRIAL-00070483TIMESterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Safety results (applied in METIV-HCC trial) have led early termination
Summary
Brief summary (as posted)
This study aims to assess the role of MET inhibitors as maintenance treatment in adult patients with extensive stage small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Small Cell | Small Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARQ197 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ARQ-197
- description
- ARQ-197 360 mg twice/day by mouth (PO), with meals, continuously as maintenance treatment until disease progression or unacceptable toxicity.
- interventionNames
- Drug: ARQ197
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- Approximately 48 months
- description
- PFS will be assessed From the date of enrollment to the date of first documented disease progression or to the date of death from any cause or to the date of a new anti-cancer therapy, whichever occurs first. Patients without a PFS event at the time of analysis will be censored at the date of last assessment.
Secondary outcomes (4)
- measure
- Overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed extensive-stage SCLC * Disease control after the first line platinum/etoposide treatment * ECOG performance status of 0 or 1 * Measurable disease according to RECIST Version 1.1 criteria * Adequate bone marrow, liver, and renal function. * Formalin Fixed Paraffin Embedded (FFPE) or frozen tumor tissue material must be available. * Resolution of any toxic effects of prior therapy according to NCI CTCAE, v 4.0 * Full recovery from significant complications of the surgery * If childbearing age, use of double-barrier contraceptive measures, oral or abstaining from sexual intercourse during the study and up to 90 days after the last dose of chemotherapy * Negative pregnancy test within 72 hours prior to the initiation of study treatment, if of childbearing potential * Signed informed consent prior to beginning protocol specific procedures * Patients must be available for treatment and follow-up Exclusion Criteria: * Previous therapies with Tivantinib or other known c-MET inhibitor * Radiotherapy for target lesions and major surgical procedure within 4 weeks, prior to the inclusion in the study * Palliative radiotherapy within 2 weeks prior to the inclusion in the study * History of malignancy in the past five years, excluding basal cell the cervix, prostate cancer with a value of prostate-specific antigen \<0.2 ng / mL * History of cardiac disease * Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infections * Pregnant or lactating women or childbearing/reproductive potential not using adequate contraception * Need for breastfeeding during or within 12 weeks of completion of the study * Gastrointestinal disorders that may interfere with the absorption of Tivantinib * Inability or unwillingness to swallow the complete doses of Tivantinib * Any known contraindication to treatment and other significant comorbid conditions which could jeopardize participation in the study
References
Publications (0)
Data not yet available
No reference posted for this study.