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Sponsored by: |
Peregrine Pharmaceuticals |
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Information provided by: | Peregrine Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00129337 |
The purpose of this study is to determine the safety of bavituximab when administered via a vein, and to examine how bavituximab behaves in the body - how quickly it is taken up by the body and how long it stays there. The effect of bavituximab on tumor responses will also be examined.
Condition | Intervention | Phase |
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Tumors |
Drug: Bavituximab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Multicenter, Open-Label Safety and Pharmacokinetics Study of Chimeric Anti-Phosphatidylserine Monoclonal Antibody (Bavituximab) in Patients With Refractory Advanced Solid Tumor Malignancies |
Estimated Enrollment: | 28 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
0.1 mg/kg
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Drug: Bavituximab
Bavituximab is a sterile drug solution supplied in glass bottles. Bavituximab will be intravenously administered over approximately 90 minutes on days 0, 7, 14 and 21 (dosage determined based on dose cohort and body weight).
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2: Experimental
0.3 mg/kg
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Drug: Bavituximab
Bavituximab is a sterile drug solution supplied in glass bottles. Bavituximab will be intravenously administered over approximately 90 minutes on days 0, 7, 14 and 21 (dosage determined based on dose cohort and body weight).
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3: Experimental
1 mg/kg
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Drug: Bavituximab
Bavituximab is a sterile drug solution supplied in glass bottles. Bavituximab will be intravenously administered over approximately 90 minutes on days 0, 7, 14 and 21 (dosage determined based on dose cohort and body weight).
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4: Experimental
3 mg/kg
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Drug: Bavituximab
Bavituximab is a sterile drug solution supplied in glass bottles. Bavituximab will be intravenously administered over approximately 90 minutes on days 0, 7, 14 and 21 (dosage determined based on dose cohort and body weight).
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The genetic variations observed in most advanced cancers decrease the effectiveness of many anti-cancer agents through the development of drug resistance. Therefore, alternative approaches to the direct targeting of cancer cells are urgently needed. Bavituximab is the generic name for a chimeric (human/murine) monoclonal antibody directed against aminophospholipids. Bavituximab is Peregrine's first investigational product under its anti-phospholipid therapy technology platform. Anti-phospholipid therapy is a novel approach to treating cancer. It is based on the finding that aminophospholipids, which are basic components of the inner surface of cells become externally exposed in response to certain disease states such as cancer. Laboratory and animal studies have demonstrated that bavituximab specifically targets cancer cells and inhibits tumor growth in a variety of experimental cancer models. This study will examine the safety and tolerability of bavituximab when administered to patients with advanced solid tumor cancers that are unresponsive to current therapies. Cohorts of 6 patients each will be treated at the starting dose of 0.1 mg bavituximab per kilogram body weight (0.1 mg/kg). Successive patient cohorts will receive 0.3, 1.0 and 3.0 mg/kg of bavituximab. Patients will be followed for a total of 56 days. Patients who demonstrate an objective tumor response will be offered further bavituximab treatment on an extension protocol.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer Lai, MBA, CCRA | 714-508-6097 | jlai@peregrineinc.com |
Contact: Dianne Uphoff, RN, CCRA | 714-508-6031 | duphoff@peregrineinc.com |
United States, Arizona | |
Arizona Cancer Center | Recruiting |
Tucson, Arizona, United States, 85724 | |
Contact: Jeanette Cardenas 520-694-9082 | |
Principal Investigator: Linda Garland, MD | |
United States, California | |
Premiere Oncology | Recruiting |
Santa Monica, California, United States, 90404 | |
Contact: Marilyn Mulay 310-633-8400 | |
Principal Investigator: Lee Rosen, MD | |
United States, North Carolina | |
ClinWorks Cancer Research Center | Recruiting |
Charlotte, North Carolina, United States, 28207 | |
Contact: Elizabeth Marx 704-333-1555 ext 112 emarx@clinworks.com | |
Principal Investigator: Raymond Thertulien, MD, PhD | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Mattie McDowell, RN, BSN 713-563-6147 | |
Principal Investigator: Nuhad Ibrahim, MD, FACP | |
Scott & White Hospital, Center for Cancer Prevention and Care | Recruiting |
Temple, Texas, United States, 76508 | |
Contact: Kericha Kennedy 254-724-5890 | |
Principal Investigator: Lucas Wong, MD |
Principal Investigator: | Nuhad Ibrahim, MD | The University of Texas MD Anderson Cancer Center |
Principal Investigator: | Linda Garland, MD | University of Arizona |
Principal Investigator: | Lee Rosen, MD | Premiere Oncology, A Medical Corporation (Santa Monica) |
Principal Investigator: | Lucas Wong, MD | Scott & White Memorial Hospital |
Principal Investigator: | Raymond Thertulien, MD, PhD | ClinWorks Cancer Research Center |
Responsible Party: | Peregrine Pharmaceuticals ( Jennifer Lai, MBA, CCRA ) |
Study ID Numbers: | PPHM 0401 |
Study First Received: | August 10, 2005 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00129337 |
Health Authority: | United States: Food and Drug Administration |
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