Clinical trial NCT02608411: TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES)
Official title: TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES). Phase II Clinical Trial, Single Arm, Two Stage
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Small Cell
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
First posted: 2015-11-18
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: Approximately 48 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Approximately 48 months
measure: Disease control rate (DCR)
timeFrame: Approximately 48 months
measure: Occurrence of all grade toxicity events assessed by CTCAE v4.0
timeFrame: 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.
measure: Quality of Life
timeFrame: Approximately 48 months
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
Study officials:
affiliation: Istituto Oncologico Veneto IRCCS
name: Giulia Pasello, MD
role: PRINCIPAL_INVESTIGATOR
References: