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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.

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

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.

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.

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

- Active and uncontrolled infection.

- Psychiatric disorders, alcohol or chemical abuse that would interfere with consent or

- 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).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2001

Completion Date:

Related Keywords:

  • Neoplasms
  • Cancer
  • Cancer Alternative Therapies
  • Living with Cancer
  • Neoplasms



Boston, Massachusetts