A Randomized Phase 2 Study of Erlotinib + ARQ 197 Versus Erlotinib + Placebo in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ArQule
ClinicalTrials.gov Identifier:
NCT00777309
First received: October 21, 2008
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

This is a randomized, placebo-controlled, double blind phase 2 study designed to compare treatment with ARQ 197 plus erlotinib to erlotinib plus placebo in patients with non-small cell lung cancer. The study will enroll patients who have had one prior chemotherapy regimen (other than erlotinib) for NSCLC.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: ARQ 197
Drug: Erlotinib
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Study of Erlotinib Plus ARQ 197 Versus Erlotinib Plus Placebo in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by ArQule:

Primary Outcome Measures:
  • Evaluate progression free survival (PFS) in patients treated with erlotinib plus ARQ 197 versus erlotinib plus placebo

Secondary Outcome Measures:
  • Evaluate overall survival (OS)
  • Overall response rate (ORR)
  • Safety of ARQ 197 in combination with erlotinib in patients with NSCLC

Enrollment: 167
Study Start Date: September 2008
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Erlotinib (150 mg) once daily plus ARQ 197 (360 mg) twice daily.
Drug: ARQ 197
360 mg administered twice daily until disease progression, unacceptable toxicity or other discontinuation criterion is met
Other Name: Tivantinib
Drug: Erlotinib
Erlotinib is a white, film coated tablet in strengths of 25, 100 and 150 mg administered once daily until disease progression, unacceptable toxicity or other discontinuation criterion is met.
Other Name: Tarceva
Active Comparator: 2
Erlotinib (150 mg) once daily plus ARQ 197 placebo twice daily
Drug: Erlotinib
Erlotinib is a white, film coated tablet in strengths of 25, 100 and 150 mg administered once daily until disease progression, unacceptable toxicity or other discontinuation criterion is met.
Other Name: Tarceva
Drug: Placebo
The placebo is provided as a capsule

Detailed Description:

This is a randomized, placebo-controlled, double blind phase 2 study designed to compare treatment with ARQ 197 plus erlotinib to erlotinib plus placebo in patients with non-small cell lung cancer. The study will enroll patients who have had one prior chemotherapy regimen (other than erlotinib) for NSCLC. The study will evaluate progression-free survival between the two arms.

A total of 154 patients will be enrolled.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide signed and dated informed consent prior to study-specific screening procedures
  2. ≥ 18 years old
  3. Histologically or cytologically confirmed inoperable locally advanced or metastatic (stage IIIB/IV) NSCLC
  4. ≥ one prior chemotherapy regimen (including adjuvant chemotherapy)(not to have included erlotinib or other EGFR inhibiting agent)
  5. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  7. Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment
  8. Females of childbearing potential must have a negative serum pregnancy test
  9. Good organ function
  10. Confirmed availability of archival pathology samples (10 unstained paraffin-embedded slides) or tissue block suitable for subsequent analysis of KRAS, EGFR, and c-Met

Exclusion Criteria:

  1. Previous receipt of erlotinib or other EGFR inhibiting therapy
  2. Receipt of any anti-tumor treatment for NSCLC within 4 weeks (2 weeks for radiotherapy) prior to the start of designated treatment
  3. Documented major surgical procedure within 4 weeks prior to randomization.
  4. Symptomatic central nervous system metastases either considered in the opinion of investigator to be clinically unstable or which require steroids, anti-epileptics, or other symptom-relieving medications
  5. Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives or avoidance of pregnancy measures
  6. Significant gastrointestinal disorder that, in opinion of Investigator, could interfere with the absorption of ARQ 197 and/or erlotinib (e.g. Crohn's disease, small or large bowel resection, malabsorbtion syndrome)
  7. Unable or unwilling to swallow the complete dose of erlotinib or ARQ 197
  8. Any known contraindication to treatment with ARQ 197 or erlotinib
  9. Any known hypersensitivity to any of component of ARQ 197 or erlotinib
  10. Other malignancy within 5 years of randomization, with the exception of adequately treated intraepithelial carcinoma of the cervix uteri, prostate carcinoma with a PSA value < 0.2 ng/ml or basal or squamous cell carcinoma of the skin
  11. Previously diagnosed grade 3 or 4 (CTCAE) bradycardia or other heart arrhythmia
  12. Any other significant co-mormid condition that, in opinion of the Investigator, would impair study participation or cooperation
  13. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777309

  Show 38 Study Locations
Sponsors and Collaborators
ArQule
  More Information

No publications provided

Responsible Party: ArQule
ClinicalTrials.gov Identifier: NCT00777309     History of Changes
Other Study ID Numbers: ARQ 197-209
Study First Received: October 21, 2008
Last Updated: February 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ArQule:
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014