Status:
COMPLETED
A Study to Evaluate Subjects Treated With rhuMab 2C4 (Pertuzumab) in a Previous Genentech Phase II Cancer Study
Lead Sponsor:
Genentech, Inc.
Conditions:
Solid Cancers
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This is a multicenter, open label extension study. Subjects who have completed treatment in the parent study of pertuzumab, either alone or with a combination agent, and who received at least one dose...
Eligibility Criteria
Inclusion
- Signed informed consent
- ECOG performance status of 0, 1, or 2
- Completion of treatment in a previous Genentech sponsored, Phase II cancer study with pertuzumab, either alone or with a combination agent, in which at least one dose of pertuzumab was received in the parent study
- Less than 3 months since last dose of pertuzumab on the parent study
- Use of an effective means of contraception for men or for women of childbearing potential
- Granulocyte count \>= 1500/uL
- Platelet count \>= 75,000/uL
- Hemoglobin \>= 9 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbepoetin \[Aranesp(R)\] is permitted)
- Serum bilirubin less than or equal to the upper limit of normal (ULN) (unless due to Gilbert's disease)
- Alkaline phosphatase, AST, and ALT \<= 2.5x ULN (\<= 5x ULN for subjects with liver metastases; no alkaline phosphatase upper limit for subjects with bone metastases)
- Serum creatinine \<= 1.5x ULN
- International normalized ratio (INR) \< 1.5 and activated partial thromboplastin time (aPTT) \< 1.5x ULN (except for subjects receiving warfarin)
Exclusion
- Recent (within the last 3 months), current, or planned participation in a experimental drug study other than a Genentech-sponsored pertuzumab cancer study
- Any unresolved or irreversible NCI-CTC Grade 3 or 4 adverse event or clinically meaningful cardiac adverse event (any grade) that is pertuzumab-related and ongoing from the parent study
- Recent (within the last 3 months) or current treatment with HER pathway inhibitors other than pertuzumab (e.g., Herceptin(R) \[Trastuzumab\], Iressa\<TM\> \[gefitinib\], Tarceva\<TM\> \[erlotinib hydrochloride\], C225, CI1033, or TAK165) or other monoclonal antibodies
- Clinical evidence of central nervous system or brain metastases
- Ejection fraction ≤50%, as determined by ECHO (or MUGA)
- Uncontrolled hypercalcemia (\> 11.5 mg/dL)
- Recent anthracycline exposure (within the last 3 months) or cumulative exposure of \> 360 mg/m\^2 doxorubicin or equivalent (i.e., liposomal doxorubicin, \> 120 mg/m\^2 mitoxantrone, or \> 90 mg/m\^2 idarubicin)
- Ongoing corticosteroid use (except for subjects who are on stable doses of \< 20 mg of prednisone daily \[or equivalent\] or who are taking corticosteroids for reasons other than cancer)
- Other malignancies (except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, or basal or squamous cell skin cancer)
- Serious systemic disease, including active infection, uncontrolled hypertension (diastolic blood pressure \> 100 mmHg on two consecutive occasions), unstable angina, congestive heart failure, or myocardial infarction or unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia \[i.e., atrial fibrillation\], paroxysmal supraventricular tachycardia, or controlled hypertension are eligible)
- Liver disease (including viral or other hepatitis), current alcohol abuse, or cirrhosis
- Known human immunodeficiency virus infection
- Pregnancy or lactation
- Major surgery or significant traumatic injury within 3 weeks prior to Day 1
- Inability to comply with study and follow-up procedures
- Any diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the continued use of an investigational drug or that may render the subject at high risk from treatment complications
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00096941
Start Date
May 1 2005
End Date
October 1 2007
Last Update
June 11 2015
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