A Research Study of CP-724,714 in Patients With HER2 Overexpressing Metastatic Breast Cancer

NCT00102895

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms, Neoplasm Metastasis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Signed written and voluntary informed consent

- Histologically or cytologically confirmed breast cancer

- Stage IV (metastatic) breast cancer

- Biopsy (fresh or archival) of primary breast cancer or metastatic site demonstrating HER2 gene amplification as determined in study-specified central laboratory by fluorescence in situ hybridization (FISH)

- Prior treatment and progressive disease with at least 1 but not more than 2 cytotoxic chemotherapy regimen(s) for metastatic disease

- Those for whom the use of an investigational HER2 inhibitor is appropriate because they do not have access to approved HER2 inhibitors (e.g., Herceptin®) or for whom treatment with currently available HER2 inhibitors is inappropriate

- Limited visceral disease burden (i.e., <30% involvement of any organ) and limited disease-related symptoms (i.e., well controlled with supportive care measures)

- Presence of at least one measurable target lesion [i.e., malignant tumor mass that can be accurately measured in at least 1 dimension of >=2 cm with conventional radiographic techniques or magnetic resonance imaging, or >=1 cm with spiral CT scan as per RECIST], excluding previously irradiated lesions, bone metastasis or pleural effusion as sole manifestations of disease. If the measurable disease is restricted to a solitary lesion, its neoplastic nature must be confirmed by cytology/histology

- Eastern Cooperative Oncology Group (ECOG) performance status 0 1

- Patient available for treatment, monitoring, and follow-up. Willing and able to comply with scheduled visits, therapy plan, laboratory tests and blood sampling for pharmacokinetic (PK) analyses

- Recovery to baseline or NCI CTCAE Version 3.0 Grade 1 toxicity from all acute effects related to prior treatment, except alopecia

- Adequate Bone Marrow Function, including: a. Absolute neutrophil count (ANC) >=1500 cells/mm3; b. Platelets >=100,000 cells/mm3

- Adequate Renal Function, including: a. Estimated creatinine clearance >=60 mL/min; b. SrCr <1.5 x ULN

- Adequate Liver Function, including: a. Bilirubin <=ULN (upper limit of normal); b. AST (SGOT) <=2.5 x ULN; c. ALT (SGPT) <=2.5 x ULN

- Adequate Cardiac Function, including: a. 12-Lead electrocardiogram (ECG) with normal tracing or non clinically significant changes that do not require medical intervention; b. QTc interval <=450 msec and without history of Torsades des Pointes or other symptomatic QTc abnormality; c. Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal and 45% as measured by echocardiogram or multi gated radionuclide angiography (MUGA) within 4 weeks prior to start of study treatment

- >= 18 years old

- Female

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Women of child-bearing potential who are unwilling or unable to use an acceptable
method to avoid pregnancy for the entire study period and up to 4 weeks after study


- Women who are pregnant or breastfeeding


- Women with a positive pregnancy test on enrollment or within 72 hours prior to study
drug administration


- Prior treatment with trastuzumab (Herceptin®) or other HER2-targeting agents [e.g.,
lapatinib (GW572016), pertuzumab (Omnitarg™; rhuMab 2C4), CI 1033, EKB 569, CP
724,714]


- Cumulative dose >450 mg/m2 of doxorubicin or doxorubicin equivalents


- Prior high-dose chemotherapy requiring hematopoetic stem cell transplantation within
12 months of study treatment start


- Radiotherapy, investigational chemotherapy, biologic therapy within 4 weeks of study
treatment start


- Previous (within the last 5 years) or current malignancies arising from sites other
than breast, except for adequately treated basal cell or squamous cell skin cancer or
in situ carcinoma of the cervix uteri


- Known or clinically suspected brain metastasis or leptomeningeal disease (no screening
CT scan required) requiring therapy. Patients with asymptomatic previously treated CNS
metastases that no longer require therapy or corticosteroids/anticonvulsants for at
least 4 weeks prior to start of study treatment are eligible


- Any clinically significant gastrointestinal abnormalities, which may impair intake,
transit or absorption of the study drug, such as the inability to take oral medication
in tablet form, prior complete/partial gastrectomy or intestinal resection, or a
requirement for H2 antagonists or proton pump inhibitors


- Any mental disorder that would limit the understanding or rendering of informed
consent and/or compromise compliance with the requirements of this protocol


- Uncontrolled or significant cardiovascular disease, including: a. Myocardial
infarction within 12 months; b. Uncontrolled angina within 6 months; c. Congestive
heart failure within 6 months or left ventricular ejection fraction below local
institutional lower limit of normal or below 45%; d. Diagnosed or suspected congenital
long QT syndrome; e. Any history of clinically significant ventricular arrhythmias
(such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes); f.
Prolonged QTc interval on pre-entry electrocardiogram (>450 msec); g. Any history of
second or third degree heart block (may be eligible if currently have a pacemaker); h.
Heart rate <50/minute on pre-entry electrocardiogram; i. Uncontrolled hypertension


- History of drug-induced hyperbilirubinemia


- Concurrent treatment with approved or investigational chemotherapy, hormonal therapy,
immunotherapy, or radiotherapy (hormone replacement therapy is permitted)


- Concurrent treatment with H2 antagonists and/or proton pump inhibitors. However, H2
antagonists can be used for the treatment of an unexpected hypersensitivity reaction
during the study period. Antacids are allowed but only up to 2 hours before and 2
hours after study drug administration


- Concurrent treatment or treatment within 4 weeks of first dose with potent and/or
irreversible CYP3A4 inhibitors including: ketoconazole, itraconazole, troleandomycin,
clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir,
nefazodone, mibefradil, amiodarone and grapefruit juice


- Concurrent treatment or treatment within 4 weeks of first dose with potent inducers of
CYP3A4 including: rifampin, rifabutin, rifamycins, phenytoin, barbiturates,
carbamazepine, glucocorticoids, modafinil, phenobarbital, troglitazone, pioglitazone,
efavirenz, nevirapine, dexamethasone, and St. John's wort


- Prisoners or patients who are compulsorily detained or involuntarily incarcerated
(e.g., for treatment of infectious disease, psychiatric illness, etc.)

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Research Study of CP-724,714 in Patients With HER2 Overexpressing Metastatic Breast Cancer
Official Title  ICMJE An Open-Label, Multi-Center, Phase 2 Study Of Cp 724,714 In Patients With Her2 Overexpressing Metastatic Breast Cancer That Has Progressed After Chemotherapy For Metastatic Disease And Is Previously Untreated With A Her2 Inhibitor
Brief Summary

The main purpose of this research study is to see if the study drug, named CP-724,714, can help in the treatment of certain breast cancers that have spread to other locations in the body. Other goals of this study are to measure how long it may take for the cancer to get worse (progress), to see if there are any side effects from the study drug, to check the amount of study drug in the blood at different times, and to check to see if there is any relationship between certain blood tests and how patients may respond to the study drug.

About 25 subjects at 4 sites (hospitals and clinics) in Bulgaria and Russia will be involved in the trial. Participation in this study can last up to 48 weeks, depending on the participant's toleration of the study drug and the response of her tumor(s) to the study drug. All participants will receive CP-724,714, at a daily dose of 250 mg (4 pills) every 12 hours.

Detailed Description Pfizer decided to terminate clinical protocol A4031003 on October 7, 2005 due to the excessive number of patients with grade 3 liver function test elevations and lack of efficacy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Neoplasms
  • Neoplasm Metastasis
Intervention  ICMJE Drug: CP-724,714
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: September 2, 2005)
25
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed written and voluntary informed consent
  • Histologically or cytologically confirmed breast cancer
  • Stage IV (metastatic) breast cancer
  • Biopsy (fresh or archival) of primary breast cancer or metastatic site demonstrating HER2 gene amplification as determined in study-specified central laboratory by fluorescence in situ hybridization (FISH)
  • Prior treatment and progressive disease with at least 1 but not more than 2 cytotoxic chemotherapy regimen(s) for metastatic disease
  • Those for whom the use of an investigational HER2 inhibitor is appropriate because they do not have access to approved HER2 inhibitors (e.g., Herceptin®) or for whom treatment with currently available HER2 inhibitors is inappropriate
  • Limited visceral disease burden (i.e., <30% involvement of any organ) and limited disease-related symptoms (i.e., well controlled with supportive care measures)
  • Presence of at least one measurable target lesion [i.e., malignant tumor mass that can be accurately measured in at least 1 dimension of >=2 cm with conventional radiographic techniques or magnetic resonance imaging, or >=1 cm with spiral CT scan as per RECIST], excluding previously irradiated lesions, bone metastasis or pleural effusion as sole manifestations of disease. If the measurable disease is restricted to a solitary lesion, its neoplastic nature must be confirmed by cytology/histology
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 1
  • Patient available for treatment, monitoring, and follow-up. Willing and able to comply with scheduled visits, therapy plan, laboratory tests and blood sampling for pharmacokinetic (PK) analyses
  • Recovery to baseline or NCI CTCAE Version 3.0 Grade 1 toxicity from all acute effects related to prior treatment, except alopecia
  • Adequate Bone Marrow Function, including: a. Absolute neutrophil count (ANC) >=1500 cells/mm3; b. Platelets >=100,000 cells/mm3
  • Adequate Renal Function, including: a. Estimated creatinine clearance >=60 mL/min; b. SrCr <1.5 x ULN
  • Adequate Liver Function, including: a. Bilirubin <=ULN (upper limit of normal); b. AST (SGOT) <=2.5 x ULN; c. ALT (SGPT) <=2.5 x ULN
  • Adequate Cardiac Function, including: a. 12-Lead electrocardiogram (ECG) with normal tracing or non clinically significant changes that do not require medical intervention; b. QTc interval <=450 msec and without history of Torsades des Pointes or other symptomatic QTc abnormality; c. Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal and 45% as measured by echocardiogram or multi gated radionuclide angiography (MUGA) within 4 weeks prior to start of study treatment
  • >= 18 years old
  • Female

Exclusion Criteria:

  • Women of child-bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after study
  • Women who are pregnant or breastfeeding
  • Women with a positive pregnancy test on enrollment or within 72 hours prior to study drug administration
  • Prior treatment with trastuzumab (Herceptin®) or other HER2-targeting agents [e.g., lapatinib (GW572016), pertuzumab (Omnitarg?; rhuMab 2C4), CI 1033, EKB 569, CP 724,714]
  • Cumulative dose >450 mg/m2 of doxorubicin or doxorubicin equivalents
  • Prior high-dose chemotherapy requiring hematopoetic stem cell transplantation within 12 months of study treatment start
  • Radiotherapy, investigational chemotherapy, biologic therapy within 4 weeks of study treatment start
  • Previous (within the last 5 years) or current malignancies arising from sites other than breast, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri
  • Known or clinically suspected brain metastasis or leptomeningeal disease (no screening CT scan required) requiring therapy. Patients with asymptomatic previously treated CNS metastases that no longer require therapy or corticosteroids/anticonvulsants for at least 4 weeks prior to start of study treatment are eligible
  • Any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drug, such as the inability to take oral medication in tablet form, prior complete/partial gastrectomy or intestinal resection, or a requirement for H2 antagonists or proton pump inhibitors
  • Any mental disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this protocol
  • Uncontrolled or significant cardiovascular disease, including: a. Myocardial infarction within 12 months; b. Uncontrolled angina within 6 months; c. Congestive heart failure within 6 months or left ventricular ejection fraction below local institutional lower limit of normal or below 45%; d. Diagnosed or suspected congenital long QT syndrome; e. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes); f. Prolonged QTc interval on pre-entry electrocardiogram (>450 msec); g. Any history of second or third degree heart block (may be eligible if currently have a pacemaker); h. Heart rate <50/minute on pre-entry electrocardiogram; i. Uncontrolled hypertension
  • History of drug-induced hyperbilirubinemia
  • Concurrent treatment with approved or investigational chemotherapy, hormonal therapy, immunotherapy, or radiotherapy (hormone replacement therapy is permitted)
  • Concurrent treatment with H2 antagonists and/or proton pump inhibitors. However, H2 antagonists can be used for the treatment of an unexpected hypersensitivity reaction during the study period. Antacids are allowed but only up to 2 hours before and 2 hours after study drug administration
  • Concurrent treatment or treatment within 4 weeks of first dose with potent and/or irreversible CYP3A4 inhibitors including: ketoconazole, itraconazole, troleandomycin, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, mibefradil, amiodarone and grapefruit juice
  • Concurrent treatment or treatment within 4 weeks of first dose with potent inducers of CYP3A4 including: rifampin, rifabutin, rifamycins, phenytoin, barbiturates, carbamazepine, glucocorticoids, modafinil, phenobarbital, troglitazone, pioglitazone, efavirenz, nevirapine, dexamethasone, and St. John's wort
  • Prisoners or patients who are compulsorily detained or involuntarily incarcerated (e.g., for treatment of infectious disease, psychiatric illness, etc.)
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Bulgaria,   Russian Federation
 
Administrative Information
NCT Number  ICMJE NCT00102895
Other Study ID Numbers  ICMJE A4031003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP