A Phase 2 Study of ARQ 501 in Patients with Locally Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

• Conditions: ocally Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck; MedDRA version: 8.1Level: LLTClassification code 10063569Term: Metastatic squamous cell carcinoma

• Registration Number: EUCTR2006-001942-15-DE
• Lead Sponsor: ARQule Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Able to provide signed and dated informed consent document prior to study-specific screening procedures
2. Histologically or cytologically confirmed locally advanced, recurrent or metastatic SCCHN
3. Measurable disease as defined by RECIST (see section 9.0)
4. Age greater or equal 18years
5. Karnofsky performance status greater or equal 70 % (see Appendix B)
6. Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last infusion ARQ501.
7. Hemoglobin (Hgb) greater or equal 10 g/dl
8. Absolute neutrophil count (ANC) greater or equal 1500/mm³
9. Platelet count greater or equal 100.000/mm³
10. Total bilirubin lower or equal 1.5 * upper limit of normal (ULN) or lower or equal 3.0 * ULN with metastatic liver disease
11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) lower or equal 2.5 * ULN or lower or equal 5.0 ULN with metastatic liver disease
12. Creatinine lower or equal 1.5 ULN
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Primary tumor of nasopharyngeal origin
2. Eligible for curative surgery or radiotherapy
3. Received three or more anticancer regimens
4. Have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment
5. Have received anticancer chemotherapy, immunotherapy, radiotherapy, or investigational agents within three weeks of first infusion
6. Surgery within two weeks of first infusion
7. Have symptomatic or untreated central nervous system (CNS) involvement
8. Are pregnant or lactating
9. Previous exposure to ARQ501

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess the overall response rate (ORR) of patients treated with ARQ501;Secondary Objective: Determine the progression-free survival (PFS) rate at six months for patents treated with ARQ501.<br>Further characterize the safety of ARQ501;Primary end point(s): Primary Efficacy Analyses: Overall Response Rate<br>Tumor response will be characterized as the best overall response recorded from the time of first treatment. Best overall response will be determined using the RECIST response criteria described in Section 9.0 of this protocol. Assessment of clinical activity of ARQ 501 will be determined by the percentage of evaluable patients who exhibit a complete or partial response (i.e., CR + PR). Ninety-five percent confidence intervals (CIs) will be calculated for the response rate.<br>The number and percent of patients in each RECIST response category (CR, PR, SD, and PD) will also be summarized for the ITT patients.