Phase 2
Completed N=3
A Study to Evaluate Subjects Treated With rhuMab 2C4 (Pertuzumab) in a Previous Genentech Phase II Cancer Study
Solid Cancers
Source: ClinicalTrials.gov NCT00096941 ↗
Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Percentage of Participants Who Experienced an Adverse Event — 33.3 percentage of participants
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 of pertuzumab in the parent study are eligible for inclusion in this trial if they are continuing to receive clinical benefit.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced an Adverse Event |
33.3 | — |
| SECONDARY Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) |
0.0; 0.0; 33.3; 33.3; 33.3 | — |
Eligibility Criteria
Inclusion Criteria
- 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 [gefitinib], Tarceva [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 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
Data sourced from ClinicalTrials.gov (NCT00096941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.