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

NCT02608411 | Terminated Phase 2

• 2 other identifiers: IOV-SCLC-1-2014 TIMES2014-002497-37
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Small Cell

Outcome Measures

Primary Outcomes (1)

• 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.

  Approximately 48 months

Secondary Outcomes (4)

• Overall survival (OS)

  Approximately 48 months

• Disease control rate (DCR)

  Approximately 48 months

• Occurrence of all grade toxicity events assessed by CTCAE v4.0

  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.

• Quality of Life

  Approximately 48 months

Study Arms (1)

ARQ-197

EXPERIMENTAL

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

Drug: ARQ197

Interventions

ARQ197 DRUG

Also known as: Tivantinib

ARQ-197

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous therapies with Tivantinib or other known c-MET inhibitor
• 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

Sponsors & Collaborators

• Istituto Oncologico Veneto IRCCS: lead

Study Sites (1)

Istituto Oncologico Veneto

Padua, 35128, Italy

Location

MeSH Terms

Conditions

Carcinoma, Small Cell

Interventions

ARQ 197

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Giulia Pasello, MD

  Istituto Oncologico Veneto IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 18, 2015
• Study Start: February 19, 2016
• Primary Completion: February 21, 2017
• Study Completion: February 21, 2017
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

IT (1)