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Safety Study of ASONEP (Sonepcizumab/LT1009) to Treat Advanced Solid Tumors (ASONEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00661414
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : January 31, 2012
Information provided by (Responsible Party):
Lpath, Inc.

Tracking Information
First Submitted Date  ICMJE April 15, 2008
First Posted Date  ICMJE April 18, 2008
Last Update Posted Date January 31, 2012
Study Start Date  ICMJE April 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2008)
Safety [ Time Frame: Jan 2009 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Safety Study of ASONEP (Sonepcizumab/LT1009) to Treat Advanced Solid Tumors
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE 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.

Study Arms  ICMJE Not Provided
Publications * Visentin B, Vekich JA, Sibbald BJ, Cavalli AL, Moreno KM, Matteo RG, Garland WA, Lu Y, Yu S, Hall HS, Kundra V, Mills GB, Sabbadini RA. Validation of an anti-sphingosine-1-phosphate antibody as a potential therapeutic in reducing growth, invasion, and angiogenesis in multiple tumor lineages. Cancer Cell. 2006 Mar;9(3):225-38.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2008)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must be 18 years old.
  • Must have a confirmed diagnosis of solid tumor that has been refractory to prior therapy and for which no additional therapy of known benefit is available.
  • Must have measurable or non-measurable disease as defined by RECIST guidelines.
  • Be male or non-pregnant, non-lactating female. A negative pregnancy test within one week prior to the start of the study if a female of childbearing potential.
  • Subjects and their partners with reproductive potential must agree to use an effective contraceptive method (as deemed by the Investigator) while the subject is on study treatment and for 30 days after the last treatment.
  • Must have a life expectancy of at least 3 months.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Must not be receiving any concurrent anticancer therapy.
  • At least 4 weeks must have elapsed between any prior systemic treatment for the cancer (6 weeks for mitomycin and nitrosourea) and first dose of treatment on this protocol; at least 4 weeks must have elapsed between any prior radiation treatment for the cancer or major surgical procedure and the first dose of treatment on this protocol; all acute and chronic toxicities from prior treatment must have recovered to ≤ grade 1. Subjects with prostate cancer on Lupron® will be allowed to continue their treatment.
  • Must have physical integrity of the gastrointestinal tract.
  • Must have adequate organ and immune function as indicated by the following laboratory values:

    • Serum creatinine <1.5 x ULN or
    • Estimated creatinine clearance >45mL/min,
    • Total Bilirubin <2.0mg/dL (<34.2umol/L),
    • AST (SGOT) & ALT (SGPT) <3 x ULN,
    • Lymphocytes >LLN,
    • White Blood Cells >3.2 x 10^9cells/L,
    • Absolute Granulocyte Count >1.5 x 10^9cells/L,
    • HG >9g/dl without transfusion,
    • Platelets >100,000/µl.
  • Must understand, be able, willing and likely to fully comply with study procedures, including scheduled follow-up, and restrictions.
  • The subject must give written signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines, before completing any study related procedures.

Exclusion Criteria:

  • Clinical evidence of active CNS involvement by malignancy. Subjects whose brain metastases were treated with radiation more than 8 weeks prior to entry on the trial, off steroids for at least 4 weeks, and with no evidence of disease progression in the brain for a minimum of 8 weeks are eligible for the trial.
  • Active and uncontrolled infection.
  • Hematologic cancers.
  • Any uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the Investigator, impair a subject's ability to give informed consent or unacceptably reduce the safety of the proposed treatment.
  • Neurological or psychiatric disorders that would interfere with consent or study follow-up.
  • Known or suspected intolerance or hypersensitivity to the study materials or closely related compounds] or any of their stated ingredients.
  • History of alcohol or other substance abuse within the last year.
  • Concurrent use of steroids or other immune suppressive agent.
  • Known positive test for HIV.
  • Evidence of bowel obstruction because of the theoretical possibility of GI perforation with an anti-angiogenesis agent.
  • Female subjects who are pregnant or lactating.
  • Subjects who have previously been enrolled into this study and subsequently withdrawn.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00661414
Other Study ID Numbers  ICMJE LT1009-Onc-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lpath, Inc.
Study Sponsor  ICMJE Lpath, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: William Garland, PhD Lpath, Inc.
PRS Account Lpath, Inc.
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP