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ARQ 501 in Combination With Docetaxel in Patients With Cancer

Primary Purpose

Carcinoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ARQ 501
Sponsored by
ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma focused on measuring cancer, solid tumor, advanced solid tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Have a histologically or cytologically confirmed diagnosis of a locally advanced or metastatic carcinoma. (Patients may have either measurable or nonmeasurable disease.) Be ≥18 years old. Must not be eligible for therapy of higher curative potential. Have a Karnofsky Performance Status (KPS) of ≥70%. Have an estimated life expectancy of ≥12 weeks. Be male or non-pregnant, non-lactating female patients. Patients who are fertile agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy. Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential). Sign a written informed consent document. Have adequate organ function as determined per protocol defined laboratory value Exclusion Criteria: Have received previous treatment with ARQ 501. Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment. Are pregnant or lactating. Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up. Have received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, within 2 weeks of treatment in this study. Have not recovered from acute toxicity of all previous therapy prior to enrollment. Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. Have symptomatic or untreated central nervous system (CNS) metastases. Have a known severe hypersensitivity to docetaxel or drugs formulated with polysorbate 80.

Sites / Locations

  • Mary Crowley Medical Research Center

Outcomes

Primary Outcome Measures

Determine the safety and tolerability of ARQ 501 in combination with docetaxel

Secondary Outcome Measures

Collect information regarding antitumor activity of ARQ 501 in combination with docetaxel

Full Information

First Posted
December 10, 2004
Last Updated
April 27, 2009
Sponsor
ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
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1. Study Identification

Unique Protocol Identification Number
NCT00099190
Brief Title
ARQ 501 in Combination With Docetaxel in Patients With Cancer
Official Title
A Phase Ib Safety and Pharmacokinetic Study of ARQ 501 in Combination With Docetaxol in Adult Patients With Locally Advanced or Metastatic Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the safety of ARQ 501 in combination with docetaxel in patients with advanced or metastatic cancer. In addition, the study is designed to observe the potential the combination of ARQ 501 and docetaxel have in treating cancer.
Detailed Description
ARQ 501 has demonstrated activity in vitro against a wide range of solid tumors including lung, colorectal, breast, prostate, pancreatic, ovarian, and myeloma. To date, no histological cancer type studied appears inherently resistant to treatment with ARQ 501. In animal xenograft models of human tumors, ARQ 501 monotherapy has been effective in treating ovarian, colon, prostate, and breast cancer. When used in combination with taxane therapy, ARQ 501 has demonstrated efficacy in treating a variety of human cancers, including ovarian, breast, and colon. This study is designed to explore whether the addition of ARQ 501 to a once every three week schedule of docetaxel is a safe and tolerable regimen. The study is designed to collect safety and pharmacokinetic data on the combination regimen and to measure the antitumor activity observed in patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma
Keywords
cancer, solid tumor, advanced solid tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ARQ 501
Primary Outcome Measure Information:
Title
Determine the safety and tolerability of ARQ 501 in combination with docetaxel
Secondary Outcome Measure Information:
Title
Collect information regarding antitumor activity of ARQ 501 in combination with docetaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a histologically or cytologically confirmed diagnosis of a locally advanced or metastatic carcinoma. (Patients may have either measurable or nonmeasurable disease.) Be ≥18 years old. Must not be eligible for therapy of higher curative potential. Have a Karnofsky Performance Status (KPS) of ≥70%. Have an estimated life expectancy of ≥12 weeks. Be male or non-pregnant, non-lactating female patients. Patients who are fertile agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy. Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential). Sign a written informed consent document. Have adequate organ function as determined per protocol defined laboratory value Exclusion Criteria: Have received previous treatment with ARQ 501. Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment. Are pregnant or lactating. Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up. Have received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, within 2 weeks of treatment in this study. Have not recovered from acute toxicity of all previous therapy prior to enrollment. Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. Have symptomatic or untreated central nervous system (CNS) metastases. Have a known severe hypersensitivity to docetaxel or drugs formulated with polysorbate 80.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Casey Cunningham, MD
Organizational Affiliation
Mary Crowley Medical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

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ARQ 501 in Combination With Docetaxel in Patients With Cancer

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