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

January 27, 2012 updated by: Lpath, Inc.

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

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

37

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Premiere Oncology
    • California
      • San Diego, California, United States
        • Pacific Oncology
      • Santa Monica, California, United States, 90404
        • Premiere Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: Jan 2009
Jan 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: William Garland, PhD, Lpath, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 15, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 18, 2008

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 27, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT1009-Onc-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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