A Study of ARQ 197 Versus Investigator's Choice of Second-Line Chemotherapy in Patients With Locally Advanced or Metastatic Gastric Cancer Who Have Progressive Neoplastic Disease Following Treatment With One Prior Chemotherapy Regimen

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
ArQule
ClinicalTrials.gov Identifier:
NCT01070290
First received: February 16, 2010
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

This will be a multi-center, open-label randomized phase 2 study designed to evaluate the progression free survival (PFS) of patients with advanced gastric cancer following treatment with either ARQ 197 or one of three standard regimens (investigator's choice). Patients with unresectable (locally advanced or metastatic) gastric carcinoma who have progressive neoplastic disease following treatment with a prior regimen consisting of at least two of the drugs 5-FU, cisplatin and docetaxel. The study will also evaluate other efficacy and safety parameters including overall response rate, overall survival and adverse events in the two treatment arms.


Condition Intervention Phase
Gastric Cancer
Drug: ARQ 197
Drug: Oxaliplatin, capecitabine or irinotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Study of ARQ 197 Versus Investigator's Choice of Second-Line Chemotherapy in Patients With Locally Advanced or Metastatic Gastric Cancer Who Have Progressive Neoplastic Disease Following Treatment With One Prior Chemotherapy Regimen

Resource links provided by NLM:


Further study details as provided by ArQule:

Primary Outcome Measures:
  • Compare the progression-free survival (PFS) of ARQ 197 versus investigator's choice of second-line chemotherapy in patients with advanced gastric cancer who have failed first-line treatment.

Secondary Outcome Measures:
  • Compare overall response rate (ORR) of ARQ 197 versus investigator's choice of second-line chemotherapy
  • Compare 6-month and 1-year overall survival (OS) rates of ARQ 197 versus investigator's choice of second-line chemotherapy
  • Further characterize the safety profile of ARQ 197

Enrollment: 0
Arms Assigned Interventions
Experimental: 1
ARQ 197
Drug: ARQ 197
120 mg capsule administered twice daily
Active Comparator: 2
Investigator's choice of oxaliplatin, capecitabine or irinotecan
Drug: Oxaliplatin, capecitabine or irinotecan
Investigator's choice or oxaliplatin, capecitabine or irinotecan

  Show Detailed Description

  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 locally advanced or metastatic unresectable gastric carcinoma
  4. Progressive neoplastic disease despite treatment with a regimen consisting of at least two of the following agents given concurrently: 5-FU, cisplatin and docetaxel OR intolerance to such a regimen
  5. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
  6. Eastern Cooperative Oncology Group performance status 0 to 2
  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. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 × ULN with known metastatic liver disease
  10. Total bilirubin ≤ 1.5 × ULN
  11. Serum creatinine ≤ 1.5 x ULN
  12. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
  13. Platelets ≥ 100 x 10^9/L

Exclusion Criteria:

  1. Received more than one prior systemic regimen for the treatment of gastric cancer (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies)
  2. Known or suspected central nervous system metastases
  3. Pregnant or lactating
  4. Significant gastrointestinal disorder that, in the opinion of Investigator, could interfere with the absorption of ARQ 197 (e.g. Crohn's disease, ulcerative colitis, extensive gastric resection)
  5. Unable or unwilling to swallow ARQ 197 capsules twice daily
  6. Any contraindication to treatment with ARQ 197, capecitabine, oxaliplatin or irinotecan
  7. Prior treatment with capecitabine, oxaliplatin or irinotecan
  8. Any known hypersensitivity to any of the components of ARQ 197, capecitabine, oxaliplatin or irinotecan
  9. Treatment with an investigational agent within 30 days of first dose of protocol defined treatments
  10. Other malignancies within the last five years, 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. Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation
  12. 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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: ArQule
ClinicalTrials.gov Identifier: NCT01070290     History of Changes
Other Study ID Numbers: ARQ 197-206
Study First Received: February 16, 2010
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada

Keywords provided by ArQule:
gastric carcinoma
Locally Advanced or Metastatic Gastric Cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases
Capecitabine
Irinotecan
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014