Status:
COMPLETED
A Study of MNRP1685A in Combination With Bevacizumab With or Without Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors
Lead Sponsor:
Genentech, Inc.
Conditions:
Solid Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase Ib, open-label, dose-escalation study of MNRP1685A given by intravenous (IV) infusion as therapy for locally advanced or metastatic solid tumors.
Eligibility Criteria
Inclusion
- Adequate hematologic and end organ function
- Evaluable disease or measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST)
- Agreement to use an effective form of contraception for the duration of the study
- Inclusion Criteria Unique to Arm A:
- Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior regimen
- Inclusion Criteria Unique to Arm B:
- Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy; a maximum of two prior chemotherapy regimens is allowed
Exclusion
- Any anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks or 5 half-lives (for systemic agents), whichever is shorter, prior to initiation of study treatment with the following exceptions: hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists or antagonists for prostate cancer; herbal therapy \> 1 week prior to Day 1; hormone-replacement therapy or oral contraceptives; palliative radiotherapy for bone metastases \> 2 weeks prior to Day 1
- Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytics, or a filter of the inferior vena cava
- Leptomeningeal disease as a manifestation of the current malignancy
- 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
- Bisphosphonate therapy for symptomatic hypercalcemia
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
- Known human immunodeficiency virus (HIV) infection
- Known primary CNS malignancy, or untreated or active CNS metastases
- Pregnancy, lactation or breast feeding
- Inadequately controlled hypertension
- History of hypertensive crisis or hypertensive encephalopathy
- History of myocardial infarction or unstable angina within 6 months prior to Day 1
- New York Heart Association (NYHA) Class II or greater CHF
- 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
- History of hemoptysis within 1 month prior to Day 1
- Evidence of bleeding diathesis or significant coagulopathy in the absence of stable therapeutic anticoagulation
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to Day 1
- Clinical signs or symptoms of gastrointestinal obstruction or requirement for parenteral hydration, parenteral nutrition, or tube feeding because of an active gastrointestinal condition
- Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
- Serious, non-healing wound, active gastrointestinal ulcer, or untreated bone fracture
- Intrathoracic lung carcinoma of squamous cell histology
- Grade ≥ 2 sensory neuropathy
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- Known hypersensitivity to recombinant human antibodies
- Exclusion Criterion Unique to Arm B:
- Known significant hypersensitivity to paclitaxel or other drugs using the vehicle cremophor
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00954642
Start Date
August 1 2009
End Date
December 1 2011
Last Update
May 17 2017
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