Safety Study of ASONEP (Sonepcizumab/LT1009) to Treat Advanced Solid Tumors
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Safety [ Time Frame: Jan 2009 ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2008|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Biological: ASONEP (sonepcizumab/LT1009)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661414
|United States, Arizona|
|Scottsdale, Arizona, United States, 85260|
|United States, California|
|San Diego, California, United States|
|Santa Monica, California, United States, 90404|
|Study Director:||William Garland, PhD||Lpath, Inc.|