A Study of NM-3 Administered Orally in Patients With Advanced Solid Tumors.

NCT00046696 | Completed Phase 1

• 1 other identifier: NM-103
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoplasms

Keywords

Cancer; Cancer Alternative Therapies; Living with Cancer

Outcome Measures

Primary Outcomes (1)

• MTD of NM-3 is the dose at which less than or equal to 1 of 6 patients experiences a DLT

Secondary Outcomes (3)

• Anti-tumor activity

• VEGF and bFGF in urine, plasma and serum

• Circulating endothelial cells

Interventions

NM-3 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Boston, Massachusetts, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Neoplasms

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 1, 2002
• First Posted: October 2, 2002
• Study Start: May 1, 2001
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

US (1)