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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00954642 |
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 |
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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 |
Estimated Enrollment: | 42 |
Study Start Date: | August 2009 |
Arms | Assigned Interventions |
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A: Experimental |
Drug: bevacizumab
Intravenous repeating dose
Drug: MNRP1685A
Escalating intravenous dose
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B: Experimental |
Drug: bevacizumab
Intravenous repeating dose
Drug: MNRP1685A
Escalating intravenous dose
Drug: paclitaxel
Intravenous repeating dose
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion Criteria Unique to Arm A:
Inclusion Criteria Unique to Arm B:
Exclusion Criteria:
Exclusion Criterion Unique to Arm B:
Contact: Douglas Thieu | thieu.douglas@gene.com |
United States, Texas | |
Investigational Site | Recruiting |
San Antonio, Texas, United States, 98229 |
Study Director: | Rainer Brachmann, M.D. | Genentech |
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 |
Solid Tumor Locally Advanced Solid Tumor Avastin |
Antibodies Paclitaxel Tubulin Modulators Antimitotic Agents |
Bevacizumab Angiogenesis Inhibitors Antineoplastic Agents, Phytogenic Immunoglobulins |
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 |