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Clinical Trials/EUCTR2011-001867-28-PL
EUCTR2011-001867-28-PLActive, not recruitingNot Applicable

A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF MEGF0444A DOSED TO PROGRESSION IN COMBINATION WITH BEVACIZUMAB AND FOLFOX IN PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC COLORECTAL CANCER

Genentech, Inc0 sites120 target enrollmentStarted: February 7, 2012Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
120
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •a. Disease-Specific Inclusion Criteria
  • •Histologically or cytologically confirmed CRC not amenable to potentially curative resection with at least one measurable metastatic lesion, as defined by RECIST v1.1 (see Appendix C)
  • •Representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides with an associated pathology report must be confirmed to be available (located at the site or sent to the site from a referring institution) at any time prior to study entry
  • •b. General Inclusion Criteria
  • •Signed informed consent form
  • •Age = 18 years
  • •ECOG performance status of 0 or 1 (see Appendix E)
  • •Able to comply with the protocol
  • •Adequate hematologic and end organ function, defined by the following
  • •laboratory results obtained within 14 days prior to the first study treatment:
  • •Absolute neutrophil count (ANC) = 1500 cells/µL (without granulocyte colony-stimulating factor support within 2 weeks prior to randomization)
  • •Platelet count = 100,000/µL (without transfusion within 2 weeks prior to randomization)
  • •Hemoglobin = 9.0 g/dL
  • •Patients may be transfused or receive erythropoietic treatment to meet this criterion.
  • •AST and ALT = 3 × ULN, and alkaline phosphatase = 2.5 × ULN, with the following exceptions:
  • •Patients with documented liver metastases: AST and/or ALT = 5 × ULN
  • •Patients with documented liver or bone metastases: alkaline phosphatase = 5 × ULN
  • •Serum bilirubin = 1.5× ULN
  • •Patients with known Gilbert disease who have serum bilirubin level = 3× ULN may be enrolled
  • •International normalized ratio (INR) and activated partial thromboplastin time (aPTT) = 1.5 × ULN within 7 days prior to randomization
  • •Serum creatinine = 1.5 × ULN or creatinine clearance = 50 mL/min on the basis of the Cockroft-Gault glomerular filtration rate estimation:
  • •(140 - age) × (weight in kg) × (0.85 if female) / 72 × (serum creatinine in mg/dL)
  • •Urine dipstick for proteinuria < 2+.
  • •Patients discovered to have = 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate = 1 g of protein in 24 hours.
  • •For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form of contraception (e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for 6 months after the last dose of bevacizumab or MEGF0444A/placebo
  • •Negative serum pregnancy test within 7 days prior to starting study treatment in premenopausal women and women < 2 years after the onset of menopause
  • •Willingness and capability to be accessible for study follow-up
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 108
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

  • •a. Disease-Specific Exclusions
  • •Any prior systemic therapy (including chemotherapy, antibody therapy, tyrosine
  • •kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy or
  • •investigational therapy) before Day 1 of Cycle 1 for treatment of mCRC
  • •Patients who received prior adjuvant systemic therapy or radiotherapy for
  • •CRC are not excluded if the time interval from last administration of adjuvant therapy until disease progression is > 12 months.
  • •Patients who receive hormone-replacement therapy or oral contraceptives are not excluded
  • •Patients who received herbal therapy intended as anti-cancer therapy = 2 weeks prior to Day 1 are not excluded
  • •b. General Medical Exclusions
  • •Malignancies other than CRC within 5 years prior to randomization, except for those with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
  • •Radiotherapy to any site for any reason within 28 days prior to Day 1 of Cycle 1
  • •Palliative radiotherapy to bone lesions > 7 days prior to Day 1 of Cycle 1 is allowed
  • •Clinically detectable (by physical exam) third-space fluid collections (e.g., ascites or pleural effusion) that cannot be controlled by drainage or other procedures prior to study entry
  • •Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to Day 1 of Cycle 1
  • •Lactating women
  • •Known hypersensitivity to Chinese hamster ovary cell products, recombinant human antibodies or any of the chemotherapy agents to be used in this study
  • •Any disorder that compromises the ability of the patient to provide written informed consent and/or to comply with study procedures
  • •Clinically suspected or confirmed CNS metastases or carcinomatous meningitis
  • •Active infection requiring IV antibiotics
  • •Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs, inhaled corticosteroids, or the equivalent of = 10 mg/day prednisone
  • •Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
  • •Sensory peripheral neuropathy = Grade 2
  • •c. Bevacizumab-Specific Exclusions
  • •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of bevacizumab or an investigational drug or that may affect the interpretation of the results or render the patient at high risk for treatment complications
  • •Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
  • •Anti-hypertensive therapy to achieve these parameters is allowable.
  • •Prior history of hypertensive crisis or hypertensive encephalopathy
  • •NYHA Class II or greater CHF (see Appendix F)
  • •History of myocardial infarction or unstable angina within 6 months prior to Day 1
  • •History of stroke or transient ischemic attack (TIA) within 6 months prior to Day 1
  • •Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
  • •Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
  • •Current or recent (within 10 days of first dose of study treatment) use of aspirin

Investigators

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