- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00046696
A Study of NM-3 Administered Orally in Patients With Advanced Solid Tumors.
May 19, 2015 updated by: Genzyme, a Sanofi Company
A Phase I and Pharmacokinetic Study of NM-3 Administered Orally Once or Twice Daily on Five Consecutive Days and Repeated Weekly for Six Weeks Every Eight Weeks in Patients With Advanced Solid Tumors.
A study for patients who have failed standard therapy.
If there is no dose limiting toxicities the patients will receive further cycles of therapy if there is no evidence of disease progression.
Study Overview
Detailed Description
This is a non-randomized, open-label, Phase I study.
A modified Fibonacci dose escalation will be used to determine the MTD for subsequent Phase II trials.
Study duration is expected to be 12 to 18 months.
Patients with a histological or cytological diagnosis of a solid tumor who have failed standard therapy or for whom no standard therapy exists are enrolled.
If there is no dose limiting toxicities and if patients meet the inclusion criteria and have none of the exclusion criteria of the protocol, they will receive further cycles of therapy if there is no evidence of disease progression.
Study Type
Interventional
Enrollment
32
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
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Massachusetts
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Boston, Massachusetts, United States
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients at least 18 years of age.
- All patients must have an advanced solid tumor that has failed standard therapy or for which no standard therapy exists.
- Histological or cytological diagnosis of a malignant solid tumor.
- Measurable or non-measurable disease.
- Any chemotherapy, radiotherapy, or major surgery at least 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C). Patients must have recovered from the toxic effects of any prior therapy.
- Karnofsky performance status index greater than or equal to 80.
- Must have adequate organ and immune system function according to the study design, obtained less than or equal to 7-days prior to treatment with NM-3.
- Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of study enrollment. Men and women with reproductive potential must use an effective contraceptive method while enrolled in this study and for 3 months after the patient has completed study.
- Patient must be able to swallow.
- Signed, written informed consent from patient or guardian.
- Estimated life expectancy of at least 12 weeks.
Exclusion Criteria:
- Known sensitivity to study drug or its analogs.
- Treatment with any investigational therapy within the preceding 4 weeks.
- Patients with hematological malignancies including leukemia, lymphoma, or multiple myeloma.
- Active and uncontrolled infection.
- Psychiatric disorders, alcohol or chemical abuse that would interfere with consent or follow-up.
- Uncontrolled congestive heart failure or angina.
- Pregnancy or lactation.
- Any other severe concurrent disease, which as judged by the investigator, would make the patient inappropriate for entry into this study.
- Patients with active gastrointestinal bleeding or ulceration, unhealed wounds or active thrombosis.
- Patients who are on anticoagulant therapy or taking aspirin, nonsteroidal anti-inflammatory drugs, unfractionated heparin, low molecular weight heparin, danaproid, thrombolytic agents, anti-platelet antibodies, glycoprotein IIb, IIIa antagonists, H2 blockers, or proton pump inhibitors.
- Brain or leptomeningeal metastases.
- Patients known to be HIV positive or who have an AIDS-related illness.
- Patients with a history of gastrointestinal bleeding from varices, arteriovenous malformations, Osler Weber Rendu syndrome, polyps, prior surgery, or gastric ulcerations. Patients who had bleeding not associated with a coagulopathy after surgery or gastric ulceration and who have no further bleeding or recurrence of their ulcers for more than one year are eligible for this study.
- Patients with a total accumulated doxorubicin or equivalent dose over 450 mg/m2.
- Patients with more than 1 risk factor, where a risk factor is defined as any one of the following (1-7):1. prior anthracyclines larger than 300 mg/m2 doxorubicin equivalent.2.mediastinum/left breast irradiation. 3.history of arterial hypertension (systolic blood pressure greater than 140 or diastolic blood pressure greater than 90, or receiving anti-hypertensive treatment).4. obesity (body mass index (BMI)[30]).5. diabetes mellitus (fasting plasma glucose level greater than 126 mg/dL American Diabetes Association (ADA) guidelines).6. smoking (any smoking in the month prior to study entry).7. hypercholesterolemia (greater than 240 mg/dL).
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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MTD of NM-3 is the dose at which less than or equal to 1 of 6 patients experiences a DLT
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Secondary Outcome Measures
Outcome Measure |
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Anti-tumor activity
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VEGF and bFGF in urine, plasma and serum
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Circulating endothelial cells
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
Helpful Links
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
May 1, 2001
Primary Completion (Actual)
October 1, 2006
Study Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
October 1, 2002
First Submitted That Met QC Criteria
October 1, 2002
First Posted (Estimate)
October 2, 2002
Study Record Updates
Last Update Posted (Estimate)
May 20, 2015
Last Update Submitted That Met QC Criteria
May 19, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- NM-103
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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