A Study of ARRY-334543 in Patients With Advanced Cancer

NCT00637702 | Completed Phase 1

• 1 other identifier: ARRAY-543-103
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase 1 study during which patients with advanced solid tumors will receive a new formulation of investigational study drug ARRY-334543. Patients will receive increasing doses of study drug in order to achieve the highest dose possible that will not cause unacceptable side effects. The patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. In addition, the effect of food on the new formulation will be evaluated. Approximately 24 patients from Canada will be enrolled in this study (Active, not recruiting).

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (4)

• Characterize the safety profile of the new formulation of study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.

  Duration of study

• Establish the maximum tolerated dose (MTD) of the new formulation of study drug.

  Duration of study

• Characterize the pharmacokinetics (PK) of the new formulation of study drug (in terms of plasma concentrations) when administered in a fed versus fasted state.

  Day 1 and Day 8

• Assess the exposure of the new formulation of study drug in terms of plasma concentrations.

  Duration of study

Secondary Outcomes (1)

• Assess the efficacy of the new formulation of study drug in terms of tumor dimension assessment.

  Duration of study

Study Arms (1)

ARRY-334543

EXPERIMENTAL

Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral

Interventions

ARRY-334543, EGFR/ErbB2 inhibitor; oral DRUG

single dose and multiple dose, escalating

ARRY-334543

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological evidence of malignancy.
• Patients with advanced solid tumors who are no longer candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
• Cardiac ejection fraction ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition (MUGA).
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
• Additional criteria exist.

You may not qualify if:

• Uncontrolled brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days).
• Use of an investigational medication or device within 30 days prior to first dose of study drug.
• Major surgery within 30 days prior to first dose of study drug.
• Radiotherapy or chemotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
• Active, uncontrolled infection requiring systemic antibiotic therapy or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment.
• Pregnancy or lactation.
• Known positive serology for the human immunodeficiency virus (HIV), 'active' hepatitis B and/or hepatitis C.
• Additional criteria exist.

Sponsors & Collaborators

• Array Biopharma, now a wholly owned subsidiary of Pfizer: lead

Study Sites (2)

Juravinski Cancer Center at Hamilton Heath Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Interventions

ARRY-334543

Study Officials

• Pizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 18, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

CA (2)