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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
Sponsor:
Information provided by (Responsible Party):
Istituto Oncologico Veneto IRCCS

Brief Summary:
This study aims to assess the role of MET inhibitors as maintenance treatment in adult patients with extensive stage small cell lung cancer.

Condition or disease Intervention/treatment Phase
Carcinoma, Small Cell Drug: ARQ197 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: ARQ-197
ARQ-197 360 mg twice/day by mouth (PO), with meals, continuously as maintenance treatment until disease progression or unacceptable toxicity.
Drug: ARQ197
Other Name: Tivantinib




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Italy
Istituto Oncologico Veneto
Padova, Italy, 35128
Sponsors and Collaborators
Istituto Oncologico Veneto IRCCS
Investigators
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Principal Investigator: Giulia Pasello, MD Istituto Oncologico Veneto IRCCS

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Responsible Party: Istituto Oncologico Veneto IRCCS
ClinicalTrials.gov Identifier: NCT02608411     History of Changes
Other Study ID Numbers: IOV-SCLC-1-2014 TIMES
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Small Cell Lung Carcinoma
Carcinoma, Small Cell
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type