NeoplasmsPhase 1NCT00046696
A Study of NM-3 Administered Orally in Patients With Advanced Solid Tumors.
A Phase 1 study testing NM-3 in people with Neoplasms, run by Genzyme, a Sanofi Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- NM-3
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2001to Oct 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this 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.
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.
Read the 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.
- Conditions
- Neoplasms
- Being tested
- NM-3
- Keywords
- Cancer, Cancer Alternative Therapies, Living with Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NM-3Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2002 (estimated)
- Study startMay 2001
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046696
- Sponsor's protocol ID
- NM-103
- Status last verified
- May 2015
- First submitted
- 1 Oct 2002
- Last updated
- 20 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00046696
- Acronym / sponsor ID
- NM-103
- Conditions
- Neoplasms
- Keywords
- Cancer, Cancer Alternative Therapies, Living with Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 2 Oct 2002 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| NM-3 | Drug | – |
Primary outcome
MTD of NM-3 is the dose at which less than or equal to 1 of 6 patients experiences a DLT
3 secondary outcomes
Anti-tumor activity
VEGF and bFGF in urine, plasma and serum
Circulating endothelial cells
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 20 May 2015.
- Related InfoLink provided by the sponsor.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NM-3 in people with Neoplasms, run by Genzyme, a Sanofi Company at 1 site 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 11 inclusion and 15 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 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
MTD of NM-3 is the dose at which less than or equal to 1 of 6 patients experiences a DLT. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2015.