- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00055926
CP-724,714 in Treating Patients With Metastatic Breast Cancer
A Phase I Safety and Pharmacokinetic/Pharmacodynamic Study of CP-724, 714 In Patients With Metastatic HER2-Overexpressing Breast Cancer
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.
Studieoversikt
Detaljert beskrivelse
OBJECTIVES:
- Determine the safety and tolerability of CP-724,714 in patients with metastatic HER2-overexpressing breast cancer.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine, preliminarily, any antitumor activity of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the relationship of drug-related adverse events to pharmacokinetic exposure parameters in these patients.
- Determine the relationship of changes in serum HER2 extracellular domain and HER2 receptor tyrosine kinase phosphorylation to pharmacokinetic exposure parameters and clinical outcome in patients treated with this drug.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive oral CP-724,714 on days 1 and 3-21 during course 1 and then daily during subsequent courses. Courses repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CP-724,714 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for at least 30 days.
PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 6 months.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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California
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Los Angeles, California, Forente stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
- At least 4 weeks since prior trastuzumab (Herceptin)
- At least 4 weeks since other prior biologic therapy or immunotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
- At least 6 months since prior doxorubicin or doxorubicin equivalents without any prior or developing signs or symptoms of cardiomyopathy
- No cumulative doses of more than 300 mg/m^2
- At least 2 weeks since prior hormonal therapy for the primary disease
- Concurrent hormone replacement therapy or luteinizing hormone-releasing hormone agonists allowed
- At least 4 weeks since prior radiotherapy
- At least 3 weeks since prior major surgery (2 weeks for minor surgery)
- Recovered from prior therapy
- At least 4 weeks since prior investigational treatment
- Coumarin or heparin derivatives allowed for the prevention of deep vein thrombosis or port patency
Exclusion Criteria:
- 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
- concurrent anticoagulant at therapeutic doses
- other concurrent experimental anticancer medications for breast cancer
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Masking: Ingen (Open Label)
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CDR0000271533
- UCLA-0209105
- PFIZER-A4031001
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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