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

NCT01070290 | Withdrawn Phase 2 DMC

• 1 other identifier: ARQ 197-206
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gastric Cancer

Keywords

gastric carcinoma; Locally Advanced or Metastatic Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

1

EXPERIMENTAL

ARQ 197

Drug: ARQ 197

2

ACTIVE COMPARATOR

Investigator's choice of oxaliplatin, capecitabine or irinotecan

Drug: Oxaliplatin, capecitabine or irinotecan

Interventions

ARQ 197 DRUG

120 mg capsule administered twice daily

1

Oxaliplatin, capecitabine or irinotecan DRUG

Investigator's choice or oxaliplatin, capecitabine or irinotecan

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide signed and dated informed consent prior to study-specific screening procedures
• ≥ 18 years old
• Histologically or cytologically confirmed locally advanced or metastatic unresectable gastric carcinoma
• 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
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
• Eastern Cooperative Oncology Group performance status 0 to 2
• 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
• Females of childbearing potential must have a negative serum pregnancy test
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 × ULN with known metastatic liver disease
• Total bilirubin ≤ 1.5 × ULN
• Serum creatinine ≤ 1.5 x ULN
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
• Platelets ≥ 100 x 10\^9/L

You may not qualify if:

• Received more than one prior systemic regimen for the treatment of gastric cancer (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies)
• Known or suspected central nervous system metastases
• Pregnant or lactating
• 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)
• Unable or unwilling to swallow ARQ 197 capsules twice daily
• Any contraindication to treatment with ARQ 197, capecitabine, oxaliplatin or irinotecan
• Prior treatment with capecitabine, oxaliplatin or irinotecan
• Any known hypersensitivity to any of the components of ARQ 197, capecitabine, oxaliplatin or irinotecan
• Treatment with an investigational agent within 30 days of first dose of protocol defined treatments
• 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
• Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation
• Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

Sponsors & Collaborators

• ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA): lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

ARQ 197; Oxaliplatin; Capecitabine; Irinotecan

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 18, 2010
• Last Updated: January 7, 2014

Record last verified: 2014-01