Advanced and/or Metastatic Solid TumoursPhase 1NCT00369252
Phase I Study of Nimotuzumab in Solid Tumours
A Phase 1 study testing Nimotuzumab (TheraCIM h-R3) in people with Advanced and/or Metastatic Solid Tumours, run by YM BioSciences at 1 site in Canada.
Trial summary
This is a phase I trial of nimotuzumab that will be conducted in patients with advanced incurable solid tumors. This is a dose-seeking study to determine the maximum tolerated and recommended phase II doses of nimotuzumab that can be safely given to patients with advanced and/or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced and/or Metastatic Solid Tumours
- What is being tested?
- Nimotuzumab (TheraCIM h-R3)
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2005to not given
- 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
- Advanced and/or metastatic solid tumors, refractory to standard curative therapy, or for which no curative therapy exists.
- Clinically or radiologically documented disease. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan.
- Archival tumor specimens evaluable for expression of the EGFR (but EGFR positivity is not a requirement for study entry).
- Patients must have tumor lesions accessible for biopsy for correlative studies. In cases where there are medical contraindications to tumor biopsies, exceptions may be made upon discussion with the Principal Investigators.
- Age > 18 years.
- ECOG performance status of 0,1,2.
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- Previous therapy: Previous chemotherapy, hormonal therapy, radiation and/or surgery is permitted with certain restrictions as outlined in the protocol.
- Hematology and chemistry lab results within specifications outlined in the protocol.
- Willingness to give written informed consent.
- Patients must be accessible for treatment and follow-up.
- Protocol treatment is to begin within 2 working days of patient registration.
Who cannot join
- Pregnant or lactating women. Both men and women enrolled on study should be using adequate birth control measures throughout the course of the study.
- History of second malignancy who have a disease-free interval of less than two years (except cervical cancer in situ or nonmelanomatous skin cancer).
- Untreated brain or meningeal metastases. Patients with treated and stable brain metastases are eligible providing that they have radiologic evidence of disease stabilisation of at least 3 months duration and are asymptomatic.
- Untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction.
- Active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
- Prior therapy with EGFR targeting therapies, including monoclonal antibodies or small molecule tyrosine kinase inhibitors.
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- Allergy to the antibody.
- Concurrent treatment with other experimental drugs or anti-cancer therapy.
- Inability or unwillingness to give written, informed consent prior to study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of TheraCIM-hR3 (YMB1000) in Patients With Solid Tumours
This is a phase I trial of nimotuzumab that will be conducted in patients with advanced incurable solid tumors. This is a dose-seeking study to determine the maximum tolerated and recommended phase II doses of nimotuzumab that can be safely given to patients with advanced and/or metastatic solid tumors.
Read the detailed description
This is an open-label, dose-escalating, phase I trial of nimotuzumab in patients with advanced incurable solid tumors. The objective of this study is to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of nimotuzumab that can be given in a weekly schedule in patients with advanced and/or metastatic solid tumor cancer. This study will also examine the safety, pharmacodynamics and preliminary efficacy of nimotuzumab in this patient population.
- Conditions
- Advanced and/or Metastatic Solid Tumours
- Being tested
- Nimotuzumab (TheraCIM h-R3)
- Keywords
- Nimotuzumab, TheraCIM, H-R3, Solid tumours, EGFR, Monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimotuzumab (TheraCIM h-R3)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced and/or Metastatic Solid TumoursStudies 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
- 18 participants
Sponsor and investigators
- Lead sponsor
- YM BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CIMYM BioSciences
- Investigators
- Eric Chen, MD, Principal investigator, University Health Network, TorontoLillian Siu, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369252
- Sponsor's protocol ID
- YMB1000-007
- Status last verified
- Feb 2007
- First submitted
- 25 Aug 2006
- Last updated
- 28 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of TheraCIM-hR3 (YMB1000) in Patients With Solid Tumours
- ClinicalTrials.gov ID
- NCT00369252
- Acronym / sponsor ID
- YMB1000-007
- Conditions
- Advanced and/or Metastatic Solid Tumours
- Keywords
- Nimotuzumab, TheraCIM, H-R3, Solid tumours, EGFR, Monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- YM BioSciencesIndustry (pharma, biotech, devices)
- Collaborators
- CIMYM BioSciences
- Study start
- Jun 2005
- First posted
- 29 Aug 2006 (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.
This is a phase I trial of nimotuzumab that will be conducted in patients with advanced incurable solid tumors. This is a dose-seeking study to determine the maximum tolerated and recommended phase II doses of nimotuzumab that can be safely given to patients with advanced and/or metastatic solid tumors.
Detailed description
This is an open-label, dose-escalating, phase I trial of nimotuzumab in patients with advanced incurable solid tumors. The objective of this study is to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of nimotuzumab that can be given in a weekly schedule in patients with advanced and/or metastatic solid tumor cancer. This study will also examine the safety, pharmacodynamics and preliminary efficacy of nimotuzumab in this patient population.
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)
- Advanced and/or metastatic solid tumors, refractory to standard curative therapy, or for which no curative therapy exists.
- Clinically or radiologically documented disease. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan.
- Archival tumor specimens evaluable for expression of the EGFR (but EGFR positivity is not a requirement for study entry).
- Patients must have tumor lesions accessible for biopsy for correlative studies. In cases where there are medical contraindications to tumor biopsies, exceptions may be made upon discussion with the Principal Investigators.
- Age > 18 years.
Key exclusion criteria (9 listed)
- Pregnant or lactating women. Both men and women enrolled on study should be using adequate birth control measures throughout the course of the study.
- History of second malignancy who have a disease-free interval of less than two years (except cervical cancer in situ or nonmelanomatous skin cancer).
- Untreated brain or meningeal metastases. Patients with treated and stable brain metastases are eligible providing that they have radiologic evidence of disease stabilisation of at least 3 months duration and are asymptomatic.
- Untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction.
- Active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
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 |
|---|---|---|
| Nimotuzumab (TheraCIM h-R3) | 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 28 Feb 2007.
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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.
Eric Chen, MD principal investigator
University Health Network, Toronto
Lillian Siu, MD principal investigator
University Health Network, Toronto
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 Nimotuzumab (TheraCIM h-R3) in people with Advanced and/or Metastatic Solid Tumours, run by YM BioSciences at 1 site in Canada.
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 9 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 28 Feb 2007. 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 Canada. 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.
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 28 Feb 2007.