TIvantinib as Maintenance Treatment in Extended Small-cel... | NCT02608411

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

NCT02608411

Sponsor

Istituto Oncologico Veneto IRCCS

Status

Terminated

Last Update Posted

Oct 13, 2023Actual

Enrollment

5Actual

Phase

Phase 2

Conditions

Carcinoma, Small Cell

Interventions

ARQ197

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2014-002497-37	EudraCT Number

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Safety results (applied in METIV-HCC trial) have led early termination

Expanded Access Info

Start Date

Feb 19, 2016Actual

Primary Completion Date

Feb 21, 2017Actual

Completion Date

Feb 21, 2017Actual

First Submitted Date

Nov 10, 2015

First Submission Date that Met QC Criteria

Nov 16, 2015

First Posted Date

Nov 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2023

Last Update Posted Date

Oct 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Label	Type	Description	Intervention Names
ARQ-197	Experimental	ARQ-197 360 mg twice/day by mouth (PO), with meals, continuously as maintenance treatment until disease progression or unacceptable toxicity.	Drug: ARQ197

Name	Type	Description	Arm Group Labels	Other Names
ARQ197	Drug		ARQ-197	Tivantinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Disease control rate (DCR)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms