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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-19

Study Completion Date

2017-02-21

Brief Summary

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

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Detailed Description

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Conditions

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Carcinoma, Small Cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ARQ-197

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

Group Type EXPERIMENTAL

ARQ197

Intervention Type DRUG

Interventions

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ARQ197

Intervention Type DRUG

Other Intervention Names

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Tivantinib

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No