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

• Status: Terminated
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Oncologico Veneto IRCCS

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