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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01244191




Registration number
NCT01244191
Ethics application status
Date submitted
17/11/2010
Date registered
19/11/2010

Titles & IDs
Public title
Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of ARQ197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer (NSCLC)
Secondary ID [1] 0 0
2010-022365-10
Secondary ID [2] 0 0
ARQ197-A-U302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Squamous, Non-small-cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tivantinib
Treatment: Drugs - Placebo
Treatment: Drugs - Erlotinib

Experimental: Tivantinib and erlotinib - Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day

Active comparator: Placebo and erlotinib - Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day


Treatment: Drugs: Tivantinib
Tivantinib 720 mg daily as 3 x 120 mg oral tablets given twice a day

Treatment: Drugs: Placebo
Tivantinib Placebo tablets given twice a day

Treatment: Drugs: Erlotinib
Erlotinib 150 mg oral tablets, given once a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
Timepoint [1] 0 0
Date of randomization up to date of death, up to approximately 1 year 11 months postdose
Secondary outcome [1] 0 0
Progression-free Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
Timepoint [1] 0 0
Date of randomization to disease progression or death (whichever comes first), up to 1 year 11 months postdose
Secondary outcome [2] 0 0
Overall Survival in the Epidermal Growth Factor Receptor Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
Timepoint [2] 0 0
Date of randomization up to date of death, up to approximately 1 year 11 months postdose
Secondary outcome [3] 0 0
Progression-free Survival in the Epidermal Growth Factor Receptor (EGFR) Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants Non-Squamous NSCLC
Timepoint [3] 0 0
Date of randomization to disease progression or death (whichever comes first), up to 1 year 11 months postdose
Secondary outcome [4] 0 0
Best Overall Tumor Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
Timepoint [4] 0 0
From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to 1 year 11 months postdose
Secondary outcome [5] 0 0
Duration of Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
Timepoint [5] 0 0
From the date of first objective response (CR or PR) or SD to date of progressive disease, up to 1 year 11 months postdose
Secondary outcome [6] 0 0
Treatment-Emergent Adverse Events Reported in =5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Timepoint [6] 0 0
Baseline up to 30 days after last dose, up to 1 year 11 months postdose
Secondary outcome [7] 0 0
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by =5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
Timepoint [7] 0 0
Baseline up to 30 days after last dose, up to 1 year 11 months postdose

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous non-small-cell lung cancer.
* Measurable disease and documented disease progression following last prior therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, Version 1.1.
* Have received one or two prior lines of systemic anti-cancer therapy therapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy. Patients who received only adjuvant treatment will be eligible only if disease progression occurred <6 months after completion of adjuvant therapy. Prior maintenance therapy is allowed and will be considered as the same line of therapy when continued without discontinuation after initiation of a treatment regimen.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Resolution of any toxic effects of prior therapy (including radiotherapy) according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0, Grade =1 (with the exception of alopecia and =grade 2 neuropathy). Subject must have recovered from significant surgery-related complications.
* Demonstrate adequate bone marrow, liver, and renal functions, defined as:
* ALT, AST, and alkaline phosphatase = 2.5 × upper limit of normal (ULN) in subjects with no liver metastasis and =5.0 x ULN in subjects with liver metastasis.
* Total bilirubin = 1.5 × ULN (= 4 × ULN total and =1.5 × ULN direct bilirubin is acceptable for subjects with Gilbert's syndrome).
* ANC =1.5 × 10^9/L.
* Platelet count =100 × 10^9/L.
* Hemoglobin =9.0 g/dL (transfusion and/or growth factor support allowed).
* Serum creatinine =1.5 × ULN or creatinine clearance = 60 mL/min.
* Archival and/or fresh biopsy tissue sample must be available for biomarker determination. The status of the following biomarkers will be collected in this study: EGFR and KRAS mutation status prior to randomization, and MET status post randomization
* If of child-bearing/reproductive potential (female or male), must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received
* If female and of childbearing potential, must have a negative result of a pregnancy test (serum or urine) within 72 hours prior to initiating study treatment.
* Must have signed and dated an approved Informed Consent Form (Including HIPAA authorization, if applicable) before performance of any study-specific procedures or tests. Subjects must be fully informed about their illness and the investigational nature of the study protocol (including forseeable risks and possible side effects)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior therapy with an EGFR inhibitor and/or ARQ 197 (or other known c-MET inhibitor).
* Receipt of any systemic anti-tumor treatment for NSCLC within 3 weeks prior to randomization.
* Receipt of palliative radiotherapy within 2 weeks or radiotherapy for curative intent of target lesions within 3 weeks prior to randomization. Lesions subjected to radiotherapy within 3 weeks prior to randomization may not be used as target lesions.
* Major surgical procedure within 3 weeks prior to randomization.
* History of cardiac disease:

Congestive heart failure defined as Class II to IV per New York Heart Association classification; active coronary artery disease; previously diagnosed symptomatic bradycardia (subjects with asymptomatic bradycardia and heart rate above 50 bpm are allowed) or other cardiac arrhythmia defined as =Grade 2 according to NCI CTCAE, version 4.0, or uncontrolled hypertension; myocardial infarction that occurred within 6 months prior to study entry (myocardial infarction that occurred > 6 months prior to study entry is permitted).

* Clinically unstable central nervous system (CNS) metastasis (to be enrolled in the study, subjects must have confirmation of stable disease by MRI or computed tomography (CT) scan within 4 weeks of randomization and have CNS metastases well controlled by steroids, anti-epileptics or other symptom-relieving medications).
* Need to breastfeed a child during or within 12 weeks of completing the study.
* Significant gastrointestinal disorder that, in the opinion of the investigator, could interfere with absorption of ARQ 197 and/or erlotinib (eg, Crohn's disease, small or large bowel resection, malabsorption syndrome).
* Inability or unwillingness to swallow the complete doses of ARQ 197 or erlotinib.
* Any known contraindication to treatment with, including hypersensitivity to, ARQ 197 or erlotinib.
* History of malignancy other than NSCLC within the 5 years prior to randomization, with the exceptions of adequately treated intraepithelial carcinoma of the cervix uteri; prostate carcinoma with a prostate-specific antigen value <0.2 ng/mL; or basal or squamous-cell carcinoma of the skin.
* Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
* Any other significant co-morbid condition that, in opinion of the investigator, would impair study participation or cooperation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/12/2012
Sample size
Target
Accrual to date
Final
1048
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
- Greenslopes
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Perth
Recruitment hospital [5] 0 0
- St. Leonards
Recruitment hospital [6] 0 0
- Wollongong
Recruitment hospital [7] 0 0
- Woodville
Recruitment postcode(s) [1] 0 0
4120 - Greenslopes
Recruitment postcode(s) [2] 0 0
- Camperdown
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- Kogarah
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment postcode(s) [5] 0 0
2065 - St. Leonards
Recruitment postcode(s) [6] 0 0
- Wollongong
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- Woodville
Recruitment outside Australia
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Santa Fe
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Cordoba
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Viedma
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Pyatigorsk
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St Petersburg
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St. Petersburg
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Tula
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Coruna
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La Laguna
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Sevilla
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Valencia
Country [179] 0 0
Spain
State/province [179] 0 0
Zaragoza
Country [180] 0 0
Sweden
State/province [180] 0 0
Linkoping
Country [181] 0 0
Sweden
State/province [181] 0 0
Lund
Country [182] 0 0
United Kingdom
State/province [182] 0 0
Surrey
Country [183] 0 0
United Kingdom
State/province [183] 0 0
Aberdeen
Country [184] 0 0
United Kingdom
State/province [184] 0 0
Glasgow
Country [185] 0 0
United Kingdom
State/province [185] 0 0
London
Country [186] 0 0
United Kingdom
State/province [186] 0 0
Manchester
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Nottingham
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Daiichi Sankyo
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Leader
Address 0 0
Daiichi Sankyo
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01244191