Solid TumorsPhase 1ASONEPNCT00661414
Safety Study of ASONEP (Sonepcizumab/LT1009) to Treat Advanced Solid Tumors
A Phase 1 study testing ASONEP (sonepcizumab/LT1009) in people with Solid Tumors, run by Lpath, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Tumors
- What is being tested?
- ASONEP (sonepcizumab/LT1009)
- Type of treatment
- Injection or infusion
- How many people
- 37 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2008to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pacific Oncology
San Diego, California
Premiere Oncology
Santa Monica, California, 90404
Premiere Oncology
Scottsdale, Arizona, 85260
About this 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
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.
Read the 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.
- Conditions
- Solid Tumors
- Being tested
- ASONEP (sonepcizumab/LT1009)
- Keywords
- Cancer, Solid tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASONEP (sonepcizumab/LT1009)Biological
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: Jan 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lpath, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Garland, PhD, Study director, Lpath, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661414
- Sponsor's protocol ID
- LT1009-Onc-001
- Acronym
- ASONEP
- Status last verified
- Jan 2012
- First submitted
- 15 Apr 2008
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/j.ccr.2006.02.023.
PubMed 16530706
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00661414
- Acronym / sponsor ID
- ASONEP / LT1009-Onc-001
- Conditions
- Solid Tumors
- Keywords
- Cancer, Solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Lpath, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | – |
Primary outcome
Safety
Time frame: Jan 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
- Background: PubMed 16530706Visentin 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. doi: 10.1016/j.ccr.2006.02.023.
Related trials for Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Garland, PhD study director
Lpath, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASONEP (sonepcizumab/LT1009) in people with Solid Tumors, run by Lpath, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Jan 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00661414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2012.