Carcinoma, Small CellPhase 2TIMESNCT02608411
TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES)
A Phase 2 study testing ARQ197 in people with Carcinoma, Small Cell, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Small Cell
- What is being tested?
- ARQ197
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- 19 Feb 2016to 21 Feb 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES). Phase II Clinical Trial, Single Arm, Two Stage
This study aims to assess the role of MET inhibitors as maintenance treatment in adult patients with extensive stage small cell lung cancer.
- Conditions
- Carcinoma, Small Cell
- Being tested
- ARQ197
- Medical subject headings
- Carcinoma, Small Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ197Drug
Also called Tivantinib
| Study group | Role | What they receive |
|---|---|---|
| ARQ-197 | Experimental | ARQ-197 360 mg twice/day by mouth (PO), with meals, continuously as maintenance treatment until disease progression or unacceptable toxicity. Receives: Drug: ARQ197 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 48 months
Secondary outcomes (4)
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.
Measured: Approximately 48 months
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
Measured: Approximately 48 months
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.
Measured: 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.
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.
Measured: Approximately 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study start19 Feb 2016
- Primary completion21 Feb 2017
- Study completion21 Feb 2017
Why it stopped: Safety results (applied in METIV-HCC trial) have led early termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Small CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giulia Pasello, MD, Principal investigator, Istituto Oncologico Veneto IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608411
- Sponsor's protocol ID
- IOV-SCLC-1-2014 TIMES
- Other IDs
- 2014-002497-37, 2014
- Acronym
- TIMES
- Status last verified
- Oct 2023
- First submitted
- 10 Nov 2015
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES). Phase II Clinical Trial, Single Arm, Two Stage
- ClinicalTrials.gov ID
- NCT02608411
- Acronym / sponsor ID
- TIMES / IOV-SCLC-1-2014 TIMES
- Conditions
- Carcinoma, Small Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety results (applied in METIV-HCC trial) have led early termination
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Study start
- 19 Feb 2016 (actual)
- Primary completion
- 21 Feb 2017 (actual)
- Study completion
- 21 Feb 2017 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the role of MET inhibitors as maintenance treatment in adult patients with extensive stage small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARQ-197 | Experimental | Drug: ARQ197ARQ-197 360 mg twice/day by mouth (PO), with meals, continuously as maintenance treatment until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARQ197Also: Tivantinib | Drug | ARQ-197 |
Primary outcome
Progression free survival (PFS)
Time frame: Approximately 48 months
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.
4 secondary outcomes
Overall survival (OS)
Time frame: Approximately 48 months
Disease control rate (DCR)
Time frame: Approximately 48 months
Occurrence of all grade toxicity events assessed by CTCAE v4.0
Time frame: 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.
Quality of Life
Time frame: Approximately 48 months
Results and safety
The study was stopped early (reason given: Safety results (applied in METIV-HCC trial) have led early termination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giulia Pasello, MD principal investigator
Istituto Oncologico Veneto IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARQ197 in people with Carcinoma, Small Cell, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Safety results (applied in METIV-HCC trial) have led early termination). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: Approximately 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.