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

Carcinoma, Small Cell Clinical Trial

— TIMES  

Official title:

TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES). Phase II Clinical Trial, Single Arm, Two Stage

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02608411
• Other study ID #: IOV-SCLC-1-2014 TIMES
• Secondary ID: 2014-002497-37
• Status: Terminated
• Phase: Phase 2
• Start date: February 19, 2016
• Est. completion date: February 21, 2017

Study information

• Verified date: October 2023
• Source: Istituto Oncologico Veneto IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: February 21, 2017
• Est. primary completion date: February 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Small Cell
• Small Cell Lung Carcinoma

Intervention

Drug:
• ARQ197

Locations

Country	Name	City	State
Italy	Istituto Oncologico Veneto	Padova

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Oncologico Veneto IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Approximately 48 months
Secondary	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	Approximately 48 months
Secondary	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.	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.
Secondary	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.	Approximately 48 months