Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

117

Study ID:

NCT03780517

Recruitment Status:

Active, not recruiting

Sponsor:

Boston Pharmaceuticals

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There are 3 Locations for this study

See Locations Near You

Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Institut Jules Bordet
Bruxelles , , Belgium
UZ Leuven
Leuven , , Belgium
Institut Bergonié
Bordeaux , , France
Centre Léon Bérard
Lyon , , France
Hôpital Pitié-Salpêtrière
Paris , , France
Institut Gustave Roussy
Villejuif , , France
Prince of Wales Hospital
Hong Kong , , Hong Kong
Chungbuk National University Hospital
Cheongju-si , , Korea, Republic of
Seoul National University Bundang Hospital
Gyeonggi-do , , Korea, Republic of
Asan Medical Center
Seoul , , Korea, Republic of
Korea University Anam Hospital
Seoul , , Korea, Republic of
Severance Hospital, Yonsei University College of Medicine
Seoul , , Korea, Republic of
Hospital Universitario Virgen de la Victoria
Málaga Andalucia, 29010, Spain
Hospital Germans Trias i Pujol
Badalona , , Spain
Instituto Oncológico Dr. Rosell, S.L.
Barcelona , , Spain
Start Madrid - Ciocc
Madrid , , Spain
START MADRID-FJD, Hospital Fundación Jiménez Díaz
Madrid , , Spain
Taichung Veterans General Hospital
Taichung , , Taiwan
National Taiwan University Hospital
Taipei , , Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

117

Study ID:

NCT03780517

Recruitment Status:

Active, not recruiting

Sponsor:


Boston Pharmaceuticals

How clear is this clinincal trial information?

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