A Study to Evaluate Subjects Treated With rhuMab 2C4 (Pertuzumab) in a Previous Genentech Phase II Cancer Study
Condition: Solid Cancers
Intervention: Pertuzumab
Intervention description: Pertuzumab was supplied as a single-use liquid formulation.
Intervention MeSH terms: Pertuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Healthy volunteers: No
Keywords: Advanced solid cancers; HER2; EGFR

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.
    

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 <= 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 Criteria:

          -  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