Colorectal CancerPhase 1/2NCT00041652
Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer
A Phase 1/2 study testing hMN14 (labetuzumab) in people with Colorectal Cancer and Colon Cancer, run by Gilead Sciences at 1 site in United States.
Trial summary
The purpose of this trial is to determine the safety of hMN14 at different dose levels in the treatment of either colorectal or breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colon Cancer, Rectal Cancer
- What is being tested?
- hMN14 (labetuzumab)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2000to Jun 2003
- Phase
- Phase 1/2
- 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
Disease Characteristics:
- Histologic or cytologic diagnosis or either, colonic, rectal, or breast carcinoma
- Measurable lesion diagnosed by CT scan
- Recurrent/metastatic disease considered surgically unresectable.
Prior/Concurrent Therapy:
- Chemotherapy: Patients who either have failed at least one regimen of standard systemic therapy, or are clinically asymptomatic and are not presently being considered for chemotherapy (Enrollment must occur at least 4 weeks beyond last treatment)
- Other: Prior treatment with investigational agents is excluded unless follow-up is completed and patient is off study
Patient Characteristics/Inclusion Criteria:
- Performance Status: Patients with a Karnofsky performance status > 70% (or equivalent, ECOG 0-1) and expected survival of at least 3 months.
- Hematopoietic: WBC >/= 3000 mm3, neutrophils >/= 1500 mm3, platelets >/= 75,000, CEA < 300 ng/mL
- Hepatic: Serum bilirubin </= 2.0 mg/dL, ALT < 2.5 x IULN
- Cardiovascular: Patients with LVEF >/= 40% by required MUGA/2D-ECHO study.
- Pulmonary: Patients with FEV1 >/= 60% by required Pulmonary Function Tests
- Other: Patients agreeing to use a medically effective method of contraception during and for a period of 3 months after the treatment period. A pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent. Patients with a significant concurrent medical condition that could affect the patient's ability to tolerate or complete the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Clinical Trial of Immunotherapy With Humanized MN-14 IgG in Recurrent, Metastatic, Unresectable Colorectal and Breast Carcinomas
The purpose of this trial is to determine the safety of hMN14 at different dose levels in the treatment of either colorectal or breast cancer.
- Conditions
- Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Breast Cancer
- Being tested
- hMN14 (labetuzumab)
- Keywords
- Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Breast Cancer, Breast Neoplasms
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hMN14 (labetuzumab)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2002 (estimated)
- Study startFeb 2000
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Terence Rugg, MD, Study director, Gilead SciencesLauri Welles, MD, Study chair, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041652
- Sponsor's protocol ID
- IM-T-hMN14-04
- Status last verified
- Oct 2005
- First submitted
- 11 Jul 2002
- Last updated
- 19 Aug 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Trial of Immunotherapy With Humanized MN-14 IgG in Recurrent, Metastatic, Unresectable Colorectal and Breast Carcinomas
- ClinicalTrials.gov ID
- NCT00041652
- Acronym / sponsor ID
- IM-T-hMN14-04
- Conditions
- Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Breast Cancer
- Keywords
- Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Breast Cancer, Breast Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Feb 2000
- Study completion
- Jun 2003
- First posted
- 15 Jul 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.
The purpose of this trial is to determine the safety of hMN14 at different dose levels in the treatment of either colorectal or breast cancer.
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
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 |
|---|---|---|
| hMN14 (labetuzumab) | Drug | – |
Primary outcome
Not reported in the source record.
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 19 Aug 2021.
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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.
Terence Rugg, MD study director
Gilead Sciences
Lauri Welles, MD study chair
Gilead Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing hMN14 (labetuzumab) in people with Colorectal Cancer and Colon Cancer, run by Gilead Sciences 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?
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 19 Aug 2021. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 19 Aug 2021.