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Pre-Approval Access Program (PAAP) for Pralsetinib (BLU-667) in Patients With Unresectable or Metastatic NSCLC or MTC

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ClinicalTrials.gov Identifier: NCT04204928
Expanded Access Status : Available
First Posted : December 19, 2019
Last Update Posted : December 19, 2019
Sponsor:
Information provided by (Responsible Party):
Blueprint Medicines Corporation

Brief Summary:
This is a global, multicenter, open-label pre-approval access program to provide access to pralsetinib (BLU-667) until such time that pralsetinib becomes available through other mechanisms or the Sponsor chooses to discontinue the program.

Condition or disease Intervention/treatment
Non-Small Cell Lung Cancer Medullary Thyroid Cancer Drug: pralsetinib (BLU-667)

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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.
Official Title: Pre-Approval Access Program (PAAP) for Pralsetinib (BLU-667) in Patients With Unresectable or Metastatic NSCLC or MTC



Intervention Details:
  • Drug: pralsetinib (BLU-667)
    Pralsetinib will be administered orally (PO) at a dose of 400 mg once daily (QD) in continuous 28 day cycles

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Pathologically documented, definitively diagnosed non-resectable or metastatic NSCLC with a RET-fusion or MTC
  2. Patient is not eligible for an ongoing study of pralsetinib or cannot access an ongoing study of pralsetinib
  3. Patient is ≥12 years of age
  4. Patient has received available standard therapies for their disease, or the patient is not an appropriate candidate for one or more of the available standard therapies, and requires systemic treatment for their disease
  5. Patient has adequate vital organ function, including heart, lungs, liver, kidneys, bone marrow, and endocrine, and is expected to tolerate therapy with a tyrosine kinase inhibitor (TKI)
  6. Presence of clinically symptomatic interstitial lung disease or interstitial pneumonitis, including radiation pneumonitis
  7. Patient or legal guardian, if permitted by local regulatory authorities, intends to provide informed consent prior to the start of treatment of pralsetinib
  8. Patient does not require therapy with a concomitant medication that is a strong inhibitor or strong inducer of Cytochrome P450 (CYP) 3A4
  9. Patient has not had a major surgical procedure (minor surgical procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures) within 14 days prior to the first dose of pralsetinib
  10. Women must be willing, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception during pralsetinib administration period and for at least 30 days after the last dose of pralsetinib
  11. Men, if not surgically sterile, must be willing to abstain from sexual intercourse or employ highly effective contraception during pralsetinib administration period and for at least 90 days after the last dose of pralsetinib
  12. Women must not be pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04204928


Contacts
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Contact: Blueprint Medicines 617-714-6707 medinfo@blueprintmedicines.com

Sponsors and Collaborators
Blueprint Medicines Corporation

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Responsible Party: Blueprint Medicines Corporation
ClinicalTrials.gov Identifier: NCT04204928    
Other Study ID Numbers: BLU-667-PAAP-01
First Posted: December 19, 2019    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Thyroid Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases