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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    114
  • sponsor
    Boston Pharmaceuticals
Updated on 5 March 2021
Investigator
Craig Basson, MD PhD
Primary Contact
Prince of Wales Hospital (4.4 mi away) Contact
+28 other location

Summary

This study will be conducted to assess the safety and tolerability of BOS172738 when administered to patients with advanced solid tumors with rearranged during transfection (RET) gene alterations and also to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of BOS172738.

Details
Condition Advanced Nonhaematologic Malignancies
Treatment BOS172738
Clinical Study IdentifierNCT03780517
SponsorBoston Pharmaceuticals
Last Modified on5 March 2021

Eligibility

Yes No Not Sure

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
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
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