Safety Study of ASONEP (Sonepcizumab/LT1009) to Treat Advanced Solid Tumors (ASONEP)
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|ClinicalTrials.gov Identifier: NCT00661414|
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : January 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Biological: ASONEP (sonepcizumab/LT1009)||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
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.
- Safety [ Time Frame: Jan 2009 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.|