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A Study of MNRP1685A in Combination With Bevacizumab With or Without Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors
This study is currently recruiting participants.
Verified by Genentech, August 2009
First Received: August 5, 2009   Last Updated: August 31, 2009   History of Changes
Sponsored by: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00954642
  Purpose

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.


Condition Intervention Phase
Solid Cancers
Drug: bevacizumab
Drug: MNRP1685A
Drug: paclitaxel
Phase I

Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Parallel Assignment
Official Title: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MNRP1685A, a Human IgG1 Antibody, in Combination With Bevacizumab With or Without Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Through study completion or early study discontinuation ]

Secondary Outcome Measures:
  • Pharmacokinetic (PK) parameters of MNRP1685A and bevacizumab, when appropriate, as data allow (total exposure, maximum and minimum serum concentration, clearance, and volume of distribution) [ Time Frame: Through study completion or early study discontinuation ]

Estimated Enrollment: 42
Study Start Date: August 2009
Arms Assigned Interventions
A: Experimental Drug: bevacizumab
Intravenous repeating dose
Drug: MNRP1685A
Escalating intravenous dose
B: Experimental Drug: bevacizumab
Intravenous repeating dose
Drug: MNRP1685A
Escalating intravenous dose
Drug: paclitaxel
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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
  • 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 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954642

Contacts
Contact: Douglas Thieu thieu.douglas@gene.com

Locations
United States, Texas
Investigational Site Recruiting
San Antonio, Texas, United States, 98229
Sponsors and Collaborators
Genentech
Investigators
Study Director: Rainer Brachmann, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers: ANP4667g
Study First Received: August 5, 2009
Last Updated: August 31, 2009
ClinicalTrials.gov Identifier: NCT00954642     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Solid Tumor
Locally Advanced Solid Tumor
Avastin

Study placed in the following topic categories:
Antibodies
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Bevacizumab
Angiogenesis Inhibitors
Antineoplastic Agents, Phytogenic
Immunoglobulins

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Bevacizumab
Antimitotic Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 11, 2009