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Breast NeoplasmsPhase 2NCT00102895

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

A Phase 2 study testing CP-724,714 in people with Breast Neoplasms and Neoplasm Metastasis, run by Pfizer.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms, Neoplasm Metastasis
What is being tested?
CP-724,714
How many people
25 participants
Where
No sites listed yet
Study dates
Apr 2005to Sep 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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.)

About this study

Official title: 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

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.

Read the 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.

Being tested
CP-724,714
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CP-724,714Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor Response

Secondary outcomes (1)

  1. Safety/Tolerability and Pharmacokinetics

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2005 (estimated)
  2. Study startApr 2005
  3. Study completionSep 2005

Why it stopped: See Detailed Description

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00102895
Sponsor's protocol ID
A4031003
Status last verified
Aug 2010
First submitted
3 Feb 2005
Last updated
27 Aug 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CP-724,714 in people with Breast Neoplasms and Neoplasm Metastasis, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: See Detailed Description). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor Response. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00102895.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2010.

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