Metastatic gpNMB Expressing Triple Negative Breast CancerNCT03067935
Individual Patient Expanded Access-Glembatumumab Vedotin
A study testing glembatumumab vedotin in people with Metastatic gpNMB Expressing Triple Negative Breast Cancer, run by Celldex Therapeutics.
Trial summary
Celldex endeavors to make investigational products available to patients with life-threatening diseases who have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic gpNMB Expressing Triple Negative Breast Cancer
- What is being tested?
- glembatumumab vedotin
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- The patient is 18 years of age or older.
- The patient has histologically confirmed, gpNMB expressing, metastatic triple-negative breast cancer
- Overexpression of gpNMB in at least one tumor sample as determined by a Sponsor approved laboratory using IHC methods
- The patient does not have abnormal organ function, active autoimmune disease, active infections or additional concurrent conditions that would compromise the patient's ability to safely receive glembatumumb vedotin.
- The patient is not eligible for or cannot access ongoing glembatumumab vedotin clinical trials
- The patient does not qualify for, or cannot access, other comparable or satisfactory alternative therapy for triple negative breast cancer.
- The patient is able to read and understand, and has signed a patient informed consent form, which outlines the nature of the proposed treatment and the anticipated benefits and risks of treatment with glembatumumab vedotin.
Who cannot join
- History of allergic reactions attributed to compounds of similar composition to glembatumumab vedotin, MMAE, dolastatin or auristatin.
- Pregnant or breast-feeding women, and women or men who are not willing to use effective contraception during the time from signing of informed consent through two months after the last dose of glembatumumab vedotin treatment.
- The patient was previously treated with glembatumumab vedotin or previously enrolled on the METRIC trial (regardless of which arm they were randomized to).
- Any underlying medical condition that, in the investigator's or Sponsor's opinion, will make the administration of Glembatumumab vedotin hazardous to the patient, or would obscure the interpretation of adverse events.
About this study
Celldex endeavors to make investigational products available to patients with life-threatening diseases who have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. Requests for expanded access to glembatumumab vedotin in patients with gpNMB expressing triple negative breast cancer will be considered.
- Being tested
- glembatumumab vedotin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glembatumumab vedotinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic gpNMB Expressing Triple Negative Breast CancerStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Celldex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067935
- Sponsor's protocol ID
- Glembatumumab vedotin CU
- Status last verified
- May 2018
- First submitted
- 23 Feb 2017
- Last updated
- 21 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Patient Expanded Access-Glembatumumab Vedotin
- ClinicalTrials.gov ID
- NCT03067935
- Acronym / sponsor ID
- Glembatumumab vedotin CU
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 1 Mar 2017 (actual)
- 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.
Celldex endeavors to make investigational products available to patients with life-threatening diseases who have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. Requests for expanded access to glembatumumab vedotin in patients with gpNMB expressing triple negative breast cancer will be considered.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient is 18 years of age or older.
- The patient has histologically confirmed, gpNMB expressing, metastatic triple-negative breast cancer
- Overexpression of gpNMB in at least one tumor sample as determined by a Sponsor approved laboratory using IHC methods
- The patient does not have abnormal organ function, active autoimmune disease, active infections or additional concurrent conditions that would compromise the patient's ability to safely receive glembatumumb vedotin.
- The patient is not eligible for or cannot access ongoing glembatumumab vedotin clinical trials
Key exclusion criteria (4 listed)
- History of allergic reactions attributed to compounds of similar composition to glembatumumab vedotin, MMAE, dolastatin or auristatin.
- Pregnant or breast-feeding women, and women or men who are not willing to use effective contraception during the time from signing of informed consent through two months after the last dose of glembatumumab vedotin treatment.
- The patient was previously treated with glembatumumab vedotin or previously enrolled on the METRIC trial (regardless of which arm they were randomized to).
- Any underlying medical condition that, in the investigator's or Sponsor's opinion, will make the administration of Glembatumumab vedotin hazardous to the patient, or would obscure the interpretation of adverse events.
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 |
|---|---|---|
| glembatumumab vedotin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing glembatumumab vedotin in people with Metastatic gpNMB Expressing Triple Negative Breast Cancer, run by Celldex Therapeutics.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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 21 May 2018.