TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES) (TIMES)
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|ClinicalTrials.gov Identifier: NCT02608411|
Recruitment Status : Terminated (Safety results (applied in METIV-HCC trial) have led early termination)
First Posted : November 18, 2015
Last Update Posted : June 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Small Cell||Drug: ARQ197||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES). Phase II Clinical Trial, Single Arm, Two Stage|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||February 2019|
ARQ-197 360 mg twice/day by mouth (PO), with meals, continuously as maintenance treatment until disease progression or unacceptable toxicity.
Other Name: Tivantinib
- Progression free survival (PFS) [ Time Frame: Approximately 48 months ]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.
- Overall survival (OS) [ Time Frame: Approximately 48 months ]The survival status will be assessed every 12 weeks (±14 days) until 48 months. Patients alive at the time of analysis will be censored at the date of last assessment.
- Disease control rate (DCR) [ Time Frame: Approximately 48 months ]The DCR will be defined as the percentage of patients with complete response (CR), partial response (PR) and stable disease (SD) at enrollment until the final visit
- Occurrence of all grade toxicity events assessed by CTCAE v4.0 [ Time Frame: Toxicity will be recorded during the treatment, until 30 days after the last dose of study medication, and graded according to the NCI‐ Common Terminology Criteria for Adverse Events (CTCAE) v.4. ]Toxicity will be analyzed in an "as treated" population, provided patients had received at least one dose of therapy.
- Quality of Life [ Time Frame: Approximately 48 months ]The instruments used for assessing the quality of life are the EORTC QLQ‐C30 and QLQ‐LC13 questionnaires. Quality of Life will be assessed from the date of enrollment until the end of treatment visit, that is anticipated after maximum 48 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608411
|Istituto Oncologico Veneto|
|Padova, Italy, 35128|
|Principal Investigator:||Giulia Pasello, MD||Istituto Oncologico Veneto IRCCS|