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NM-103: A Study of NM-3 Administered Orally in Patients with Advanced Solid Tumors
This study has been completed.
Sponsored By:
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Genzyme
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Information Provided By:
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Genzyme
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ClinicalTrials.gov Identifier:
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NCT00046696
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Purpose
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.
Condition
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Intervention
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Phase
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Neoplasms
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Drug: NM-3
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Phase I
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Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Official Title: 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.
Further Study Details:
Expected Total Enrollment: 32
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria
Patients must:
 | be at least 18 years of age.
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| have an advanced solid tumor that has failed standard therapy or for which no standard therapy exists.
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| have a histological or cytological diagnosis of a malignant solid tumor.
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| have measurable or non-measurable disease as defined in the protocol.
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| have completed any chemotherapy, radiotherapy, or major surgery at least 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C) and recovered from the toxic effects of any prior surgery.
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| have a Karnofsky performance status index greater than or equal to 80.
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| have adequate organ and immune system function as indicated by specific laboratory values, obtained less than or equal to 7-days prior to treatment with NM-3.
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| have a negative serum pregnancy test within 7 days of study enrollment (females of child bearing potential).
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| 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.
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| be able to swallow.
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| have signed, written informed consent.
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| an estimated life expectancy of at least 12 weeks. |
Exclusion Criteria
Patients who meet any of the following criteria will be excluded from study admission:
| Known sensitivity to study drug or its analogs.
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| Treatment with any investigational therapy within the preceding 4 weeks.
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| Hematological malignancies including leukemia, lymphoma, or multiple myeloma.
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| Active and uncontrolled infection.
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| Psychiatric disorders, alcohol or chemical abuse that would interfere with consent or follow-up.
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| Uncontrolled congestive heart failure or angina.
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| Pregnancy or lactation.
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| Any other severe concurrent disease, which as judged by the investigator, would make the patient inappropriate for entry into this study.
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| Active gastrointestinal bleeding or ulceration, unhealed wounds or active thrombosis.
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| 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.
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| Brain or leptomeningeal metastases.
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| Known HIV positive status or who have an AIDS-related illness.
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| 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.
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| Patients with a total accumulated doxorubicin or equivalent dose over 450 mg/m2.
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| Patients with more than 1 risk factor, where a risk factor is defined as any one of the following (1-7):
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- prior anthracyclines larger than 300 mg/m2 doxorubicin equivalent.
- mediastinum/left breast irradiation.
- history of arterial hypertension (systolic blood pressure greater than 140 or diastolic blood pressure greater than 90, or receiving anti-hypertensive treatment).
- obesity (body mass index).
- diabetes mellitus (fasting plasma glucose level greater than 126 mg/dL American Diabetes Association guidelines).
- smoking (any smoking in the month prior to study entry).
- hypercholesterolemia (greater than 240 mg/dL).
Location and Contact Information
Massachusetts
Boston, Massachusetts, United States
More Information
Study ID Numbers: NM-103
ClinicalTrials.gov Identifier: NCT00046696
Health Authority: United States: Food and Drug Administration
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Contact Information
Genzyme Corporation
500 Kendall Street
Cambridge, MA 02142
T:617 252 7500
F:617 252 7600
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