A Study of MNRP1685A in Combination With Bevacizumab With or Without Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors

Genentech

Status and phase

Completed

Phase 1

Conditions

Solid Cancers

Treatments

Drug: MNRP1685A

Drug: bevacizumab

Drug: paclitaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00954642

ANP4667g

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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