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Sponsored by: |
OXiGENE |
---|---|
Information provided by: | OXiGENE |
ClinicalTrials.gov Identifier: | NCT00395434 |
The purpose of this study is to determine the safety and tolerability of three dose levels of combretastatin A4 phosphate (CA4P) given intravenously (IV) in combination with bevacizumab every 14 days in patients with advanced solid tumors. The maximum tolerated dose will be defined if it is at one of the three dose levels under study.
Condition | Intervention | Phase |
---|---|---|
Tumors |
Drug: Combretastatin A4 Phosphate (CA4P) Drug: Bevacizumab (Avastin) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study |
Official Title: | OXC4P1-105: A Phase I Study of the Safety, Tolerability, and Antitumor Activity of Escalating Doses of Combretastatin A4 Phosphate Given in Combination With Bevacizumab to Subjects With Advanced Solid Tumors |
Estimated Enrollment: | 20 |
Study Start Date: | September 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow function:
Adequate hepatic function:
Exclusion Criteria:
Contraindications, allergies or sensitivity to the use of the study medications or any other products required for participation in this study (i.e.
contrast agents)
United Kingdom, Middlesex | |
Mount Vernon Hospital | |
Northwood, Middlesex, United Kingdom, HA6 2RN | |
United Kingdom, Surrey | |
Royal Marsden Hospital | |
Sutton, Surrey, United Kingdom, SM2 5PT |
Principal Investigator: | Paul Nathan, MD | Mount Vernon Hospital |
Study Director: | Hillori Connors, MS | OXiGENE |
Study Director: | Peter Harris, MD | OXiGENE |
Study ID Numbers: | OXC4P1-105 |
Study First Received: | November 1, 2006 |
Last Updated: | March 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00395434 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Advanced Solid Tumors Advanced Solid Tumours Advanced Solid Tumor Advanced Solid Tumour Advanced Malignant Solid Tumors Tumours Tumor Tumour |
Cancer Malignant Solid Tumors Malignant Solid Tumours Malignant Solid Tumor Malignant Solid Tumour Metastatic Cancer Metastatic Disease Advanced Cancer Vascular Disrupting Agent Anti-angiogenesis agent Phase 1 |
Tubulin Modulators Neoplasm Metastasis Antimitotic Agents Bevacizumab |
Antineoplastic Agents, Phytogenic Angiogenesis Inhibitors Combretastatin A-4 Combretastatin |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Bevacizumab Antimitotic Agents Combretastatin |
Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Combretastatin A-4 Antineoplastic Agents, Phytogenic |