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

Purpose

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.

Condition	Intervention	Phase
Advanced Cancer	Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral Drug: Docetaxel, mitotic inhibitor; intravenous Drug: Prophylactic growth factors; subcutaneous	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by Array BioPharma:

Primary Outcome Measures:

Establish the maximum tolerated dose (MTD) of study drug in combination with docetaxel. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Characterize the safety profile of study drug in combination with docetaxel in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Characterize the pharmacokinetics (PK) of study drug and docetaxel. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the efficacy of the study drug in combination with docetaxel in terms of tumor response. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Enrollment:	27
Study Start Date:	January 2009
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ARRY-334543 + docetaxel + prophylactic growth factors	Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral multiple dose, escalating Drug: Docetaxel, mitotic inhibitor; intravenous multiple dose, single schedule Drug: Prophylactic growth factors; subcutaneous standard of care

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key 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.

Key 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833326

Locations

United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Minnesota
Mayo Cancer Center
Rochester, Minnesota, United States, 55905
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Array BioPharma

More Information

No publications provided

Responsible Party:	Array BioPharma
ClinicalTrials.gov Identifier:	NCT00833326 History of Changes
Other Study ID Numbers:	ARRAY-543-104
Study First Received:	January 29, 2009
Last Updated:	September 28, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Antimitotic Agents
Mitogens
Docetaxel
Mitosis Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013