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)

Non Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777309
• Other study ID #: ARQ 197-209
• Status: Completed
• Phase: Phase 2
• First received: October 21, 2008
• Last updated: February 22, 2013
• Start date: September 2008
• Est. completion date: August 2011

Study information

• Verified date: February 2013
• Source: ArQule
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• ARQ 197
360 mg administered twice daily until disease progression, unacceptable toxicity or other discontinuation criterion is met
• 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.
• Placebo
The placebo is provided as a capsule

Locations

Country	Name	City	State
Russian Federation	Central Clinical Hospital #1	Moscow
Russian Federation	Central Clinical Hospital #2	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
ArQule

Countries where clinical trial is conducted

United States,  Germany,  Latvia,  Poland,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate progression free survival (PFS) in patients treated with erlotinib plus ARQ 197 versus erlotinib plus placebo
Secondary	Evaluate overall survival (OS)
Secondary	Overall response rate (ORR)
Secondary	Safety of ARQ 197 in combination with erlotinib in patients with NSCLC