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TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES) (TIMES)

Primary Purpose

Carcinoma, Small Cell

Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
ARQ197
Sponsored by
Istituto Oncologico Veneto IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Small Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Oncologico Veneto

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARQ-197

Arm Description

ARQ-197 360 mg twice/day by mouth (PO), with meals, continuously as maintenance treatment until disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Progression free survival (PFS)
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

Overall survival (OS)
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)
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
Toxicity will be analyzed in an "as treated" population, provided patients had received at least one dose of therapy.
Quality of Life
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.

Full Information

First Posted
November 10, 2015
Last Updated
October 12, 2023
Sponsor
Istituto Oncologico Veneto IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT02608411
Brief Title
TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES)
Acronym
TIMES
Official Title
TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES). Phase II Clinical Trial, Single Arm, Two Stage
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Safety results (applied in METIV-HCC trial) have led early termination
Study Start Date
February 19, 2016 (Actual)
Primary Completion Date
February 21, 2017 (Actual)
Study Completion Date
February 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Oncologico Veneto IRCCS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Small Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARQ-197
Arm Type
Experimental
Arm Description
ARQ-197 360 mg twice/day by mouth (PO), with meals, continuously as maintenance treatment until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
ARQ197
Other Intervention Name(s)
Tivantinib
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
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.
Time Frame
Approximately 48 months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
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.
Time Frame
Approximately 48 months
Title
Disease control rate (DCR)
Description
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
Time Frame
Approximately 48 months
Title
Occurrence of all grade toxicity events assessed by CTCAE v4.0
Description
Toxicity will be analyzed in an "as treated" population, provided patients had received at least one dose of therapy.
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.
Title
Quality of Life
Description
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.
Time Frame
Approximately 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giulia Pasello, MD
Organizational Affiliation
Istituto Oncologico Veneto IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Oncologico Veneto
City
Padova
ZIP/Postal Code
35128
Country
Italy

12. IPD Sharing Statement

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TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES)

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