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Individual Patient Expanded Access-Glembatumumab Vedotin

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ClinicalTrials.gov Identifier: NCT03067935
Expanded Access Status : No longer available
First Posted : March 1, 2017
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics

Brief 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. Requests for expanded access to glembatumumab vedotin in patients with gpNMB expressing triple negative breast cancer will be considered.

Condition or disease Intervention/treatment
Metastatic gpNMB Expressing Triple Negative Breast Cancer Drug: glembatumumab vedotin

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. The patient is 18 years of age or older.
  2. The patient has histologically confirmed, gpNMB expressing, metastatic triple-negative breast cancer
  3. Overexpression of gpNMB in at least one tumor sample as determined by a Sponsor approved laboratory using IHC methods
  4. 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.
  5. The patient is not eligible for or cannot access ongoing glembatumumab vedotin clinical trials
  6. The patient does not qualify for, or cannot access, other comparable or satisfactory alternative therapy for triple negative breast cancer.
  7. 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.

Exclusion Criteria:

  1. History of allergic reactions attributed to compounds of similar composition to glembatumumab vedotin, MMAE, dolastatin or auristatin.
  2. 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.
  3. The patient was previously treated with glembatumumab vedotin or previously enrolled on the METRIC trial (regardless of which arm they were randomized to).
  4. 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.

No Contacts or Locations Provided

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Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT03067935     History of Changes
Other Study ID Numbers: Glembatumumab vedotin CU
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Triple Negative Breast Neoplasms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Glembatumumab vedotin
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs