- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02608411
TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES) (TIMES)
October 12, 2023 updated by: Istituto Oncologico Veneto IRCCS
TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES). Phase II Clinical Trial, Single Arm, Two Stage
This study aims to assess the role of MET inhibitors as maintenance treatment in adult patients with extensive stage small cell lung cancer.
Study Overview
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Padova, Italy, 35128
- Istituto Oncologico Veneto
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ARQ-197
ARQ-197 360 mg twice/day by mouth (PO), with meals, continuously as maintenance treatment until disease progression or unacceptable toxicity.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival (PFS)
Time Frame: Approximately 48 months
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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.
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Approximately 48 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: Approximately 48 months
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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.
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Approximately 48 months
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Disease control rate (DCR)
Time Frame: Approximately 48 months
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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
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Approximately 48 months
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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.
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Toxicity will be analyzed in an "as treated" population, provided patients had received at least one dose of therapy.
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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.
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Quality of Life
Time Frame: Approximately 48 months
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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.
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Approximately 48 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Giulia Pasello, MD, Istituto Oncologico Veneto IRCCS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 19, 2016
Primary Completion (Actual)
February 21, 2017
Study Completion (Actual)
February 21, 2017
Study Registration Dates
First Submitted
November 10, 2015
First Submitted That Met QC Criteria
November 16, 2015
First Posted (Estimated)
November 18, 2015
Study Record Updates
Last Update Posted (Actual)
October 13, 2023
Last Update Submitted That Met QC Criteria
October 12, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IOV-SCLC-1-2014 TIMES
- 2014-002497-37 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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