CP-724,714 in Treating Patients With Metastatic Breast Cancer

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

RATIONALE: CP-724,714 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase I trial to study the effectiveness of CP-724,714 in treating patients who have metastatic HER2-overexpressing breast cancer.

Key facts

Study ID

NCT00055926

Run by

Jonsson Comprehensive Cancer Center

People needed

9

Starts

2003-01-01

Expected to finish

2005-05-01

Last updated by the study team

2020-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed HER2-overexpressing breast cancer
• Prior or newly documented HER2 amplification by fluorescence in situ hybridization (FISH)
• Progressive metastatic disease
• Must have received at least one prior chemotherapy regimen for metastatic breast cancer
• At least 1 measurable or evaluable lesion
• At least 1 lesion accessible for 2 separate core biopsies for pharmacodynamic evaluation
• 18 and over
• Male or female
• ECOG 0-1
• Life expectancy, More than 3 months
• Hematopoietic
• Absolute neutrophil count at least 1,500/mm\^3*
• Platelet count at least 100,000/mm\^3* NOTE: *Without hematopoietic growth factors or transfusions
• Hepatic
• Bilirubin no greater than 1.5 mg/dL
• AST/ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
• Renal
• Creatinine no greater than 1.5 times ULN OR
• Creatinine clearance at least 60 mL/min
• Cardiovascular
• 12-lead ECG with normal tracing
• history of cardiovascular disease (i.e., ischemic heart disease, arrhythmia, or congestive heart failure) unless asymptomatic for the past year with no requirement for antiarrhythmics or a clinically significant medical management change
• Gastrointestinal
• Able to take oral medication* Negative pregnancy test
• Fertile patients must use effective contraception

You may not qualify if…

• known or clinically suspected brain metastases or leptomeningeal disease
• symptomatic edema or third-space fluid (e.g., ascites or pleural effusions)
• known hepatitis B or C infection
• significant ECG changes that require medical intervention
• QTc interval less than 460 msec
• No history of torsade or other symptomatic QTc abnormality
• LVEF greater than 50% by MUGA
• gastrointestinal abnormality that would require medications (including all antacids)
• persistent symptoms of an esophageal or digestive disorder
• pregnant or nursing
• known HIV infection
• active infection
• concurrent uncontrolled systemic disorders or laboratory abnormalities that would preclude study drug safety evaluation
• mental disorder that would preclude study compliance or ability to give informed consent
• No more than 2 prior trastuzumab-based regimens for advanced disease
• concurrent immunotherapy
• more than 1 prior anthracycline- or anthracenedione-containing regimen (except with approval of the sponsor)
• prior high-dose chemotherapy with hematopoietic stem cell transplantation
• concurrent anticancer chemotherapy
• No concurrent anticancer hormonal therapy, including tamoxifen
• prior radiotherapy to the only disease site that would be assessed for response
• concurrent radiotherapy
• prior partial or complete gastrectomy
• concurrent antiarrhythmics
• concurrent antacids

Where it is running

• Jonsson Comprehensive Cancer Center, UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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