A Study of ARRY-334543 and Docetaxel in Patients With Advanced Cancer

NCT ID: NCT00833326

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-07-31

Brief Summary

This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and docetaxel (with prophylactic growth factor support). Patients will receive increasing doses of study drug in combination with docetaxel in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in this study.

Conditions

Advanced Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARRY-334543 + docetaxel + prophylactic growth factors

Group Type: EXPERIMENTAL

ARRY-334543, EGFR/ErbB2 inhibitor; oral

Intervention Type: DRUG

multiple dose, escalating

Docetaxel, mitotic inhibitor; intravenous

Intervention Type: DRUG

multiple dose, single schedule

Prophylactic growth factors; subcutaneous

Intervention Type: DRUG

standard of care

Interventions

ARRY-334543, EGFR/ErbB2 inhibitor; oral

multiple dose, escalating

Intervention Type: DRUG

Docetaxel, mitotic inhibitor; intravenous

multiple dose, single schedule

Intervention Type: DRUG

Prophylactic growth factors; subcutaneous

standard of care

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of any advanced/metastatic solid tumor suitable for treatment with docetaxel.
• Tumor recurred or progressed following at least one line of chemotherapy, except if no standard of care exists or if the patient refuses standard of care treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
• Must be able to take and retain oral medications.
• Other criteria exist.

Exclusion Criteria

• Active concomitant malignancies.
• Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days prior to study start).
• Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
• Requiring intravenous (IV) alimentation.
• Pregnancy or lactation.
• Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.
• Anti-ErbB1 and/or ErbB2 targeted therapy or anticancer hormonal therapy within 14 days prior to first dose of study drug.
• History of hypersensitivity to or intolerance of docetaxel.
• Other criteria exist.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Array Biopharma, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

University of Colorado Health Sciences Center

Aurora, Colorado, United States

Mayo Cancer Center

Rochester, Minnesota, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

ARRAY-543-104

Identifier Type: -

Identifier Source: org_study_id