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Sponsored by: |
Lpath, Inc. |
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Information provided by: | Lpath, Inc. |
ClinicalTrials.gov Identifier: | NCT00661414 |
The purpose of this study is to determine the safety, tolerability and highest dose of ASONEP that can safely be administered to patients with cancer who are no longer being helped by standard treatments.
Condition | Intervention | Phase |
---|---|---|
Advanced Solid Tumors |
Biological: ASONEP (sonepcizumab/LT1009) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Open-Label, Single-Arm, Phase 1, Dose Escalation Study of ASONEP (Sonepcizumab/LT1009) Administered as a Single Agent Weekly to Subjects With Refractory Advanced Solid Tumors |
Estimated Enrollment: | 37 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
ASONEP [sonepcizumab/LT1009] is supplied as a colorless,particulate-free, pH 6.5, sterile solution containing approximately 10 mg/mL or 20 mg/mL of drug.
The candidate drug is intended for single intravenous (iv) use administered over 90 minutes on a weekly basis.
ASONEP™ (sonepcizumab/LT1009) is a humanized monoclonal antibody that possesses anti-angiogenic and anti-tumor activity in animal models of human cancer. ASONEP™ binds sphingosine 1-phosphate (S1P), a bioactive lipid signaling molecule that possesses potent pro-growth effects.
Preclinical studies with ASONEP™ (sonepcizumab/LT1009) and LT1002 (murine homolog of LT1009), demonstrate the potential of an anti-S1P treatment to reduce tumor volumes and metastatic potential, likely as a result of inhibiting new blood vessel formation needed to support tumor growth.
Lpath is developing ASONEP™ (sonepcizumab/LT1009) for the following therapeutic indication:
ASONEP™ [parenteral sonepcizumab (LT1009) for the treatment of cancer] is indicated for use in combination with TBD cytotoxic agents and other anti-angiogenic agents as second-line therapy to treat patients with an unresectable, locally advanced, recurrent or metastatic TBD cancer.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Must have adequate organ and immune function as indicated by the following laboratory values:
Exclusion Criteria:
Contact: See Locations Below |
United States, Arizona | |
Premiere Oncology | Recruiting |
Scottsdale, Arizona, United States, 85260 | |
Contact: Patricia J Shannon, RN, BS, OCN 480-860-5000 | |
Principal Investigator: Michael Gordon, MD | |
United States, California | |
Premiere Oncology | Recruiting |
Santa Monica, California, United States, 90404 | |
Contact: Suzanne Nichols, RN 310-633-8400 snichols@premiereoncology.com | |
Principal Investigator: Lee Rosen, MD | |
Pacific Oncology | Recruiting |
San Diego, California, United States | |
Contact: Karen L Brady, RN, MSN, OCN 760-452-3340 kbrady@pacificoncology.com | |
Principal Investigator: Richard Just, MD |
Study Director: | William Garland, PhD | Lpath, Inc. |
Responsible Party: | Lpath, Inc. ( William Garland; Vice President of Development ) |
Study ID Numbers: | LT1009-Onc-001 |
Study First Received: | April 15, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00661414 |
Health Authority: | United States: Food and Drug Administration |
Cancer Solid tumors |