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

Istituto Oncologico Veneto IRCCS

Status and phase: Terminated; Phase 2

Conditions: Carcinoma, Small Cell

Treatments: Drug: ARQ197

Study type: Interventional

Funder types: Other

Identifiers

NCT02608411

IOV-SCLC-1-2014 TIMES

2014-002497-37 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

ARQ-197

Experimental group

Description:

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

Treatment:

Drug: ARQ197