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

Sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00833326

Collaborator

(none)

Enrollment

Locations

Arm

17.9

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Establish the maximum tolerated dose (MTD) of study drug in combination with docetaxel. [Duration of study]
Characterize the safety profile of study drug in combination with docetaxel in terms of adverse events, clinical laboratory tests and electrocardiograms. [Duration of study]
Characterize the pharmacokinetics (PK) of study drug and docetaxel. [Duration of study]

Secondary Outcome Measures

Assess the efficacy of the study drug in combination with docetaxel in terms of tumor response. [Duration of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Health Sciences Center	Aurora	Colorado	United States	80045
2	Mayo Cancer Center	Rochester	Minnesota	United States	55905
3	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

Array Biopharma, now a wholly owned subsidiary of Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Array Biopharma, now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00833326

Other Study ID Numbers:

ARRAY-543-104

First Posted:

Feb 2, 2009

Last Update Posted:

Oct 6, 2020

Last Verified:

Oct 1, 2020

Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2020