Last updated on May 2020

Safety Efficacy and Tolerability of BOS172738 in Patients With Advanced Rearranged During Transfection (RET) Gene-Altered Tumors


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Advanced Nonhaematologic Malignancies
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria

apply
  • Male or female participants must be 18 years, at the time of signing the informed consent
  • Diagnosis of advanced solid tumor with a documented rearranged during transfection (RET) gene altered malignancy as determined locally by a DNA based assay of tumor tissue and/or blood
  • Participants must have no alternative approved therapy.
  • For participants in Part B expansion cohort only: documented local diagnosis of either
    1. advanced RET gene fusion non-small cell lung cancer (NSCLC); 2) advanced RET gene mutant medullary thyroid cancer (MTC); or 3) other RET gene altered advanced tumors or NSCLC/MTC with prior specific RET gene targeted therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Negative pregnancy test for females of child bearing potential; must be surgically sterile, postmenopausal, or willing and able to be compliant with a contraceptive regimen
  • Contraceptive use by men or women should be consistent with local regulations.
  • Capable of giving signed informed consent

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Inability to take oral medications or gastrointestinal (GI) conditions that can interfere with the swallowing or absorption of study medication
  • Uncontrolled or severe concurrent medical condition
  • History of upper GI bleeding, ulceration, or perforation within 12 months prior to the first dose of study drug
  • Known history of stroke or cerebrovascular accident within 6 months prior to the first dose of study drug
  • Participants with known infection with human immunodeficiency virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS) (testing not required)
  • Participants who are hepatitis B surface antigen positive or participants who are hepatitis C antibody positive (Participants who have been successfully treated for hepatitis C virus [HCV] are eligible if an undetectable HCV viral load at least 6 months after completion of treatment can be demonstrated.)
  • Any evidence of serious active infections
  • Uncontrolled or severe cardiovascular disease
  • Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
  • Participants with a prior or concurrent malignancy other than the malignancies under study
  • Ongoing cancer directed therapy

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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