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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03780517
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE December 12, 2018
First Posted Date  ICMJE December 19, 2018
Last Update Posted Date September 3, 2020
Actual Study Start Date  ICMJE December 12, 2018
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
  • Number of participants with any treatment-emergent (TE) serious adverse event (SAE) [ Time Frame: a minimum of approximately 3 months ]
  • Number of participants with any non-serious TEAE [ Time Frame: a minimum of approximately 3 months ]
  • Number of participants with grade 3, grade 4, or grade 5 TEAEs [ Time Frame: a minimum of approximately 3 months ]
  • Number of participants with any related TEAE [ Time Frame: a minimum of approximately 3 months ]
  • Number of participants with any TEAE leading to study drug discontinuation [ Time Frame: a minimum of approximately 3 months ]
  • Maximum tolerated dose (MTD) of BOS172738 [ Time Frame: throughout Cycle 1 (each cycle is 28 days) ]
  • Recommended phase 2 dose (RP2D) of BOS172738 [ Time Frame: 28-day cycles in Part A (minimum of one dose of BOS172738 received) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
  • Objective Response Rate (ORR) [ Time Frame: a minimum of approximately 3 months ]
  • Objective Disease Control Rate (ODCR) [ Time Frame: a minimum of approximately 3 months ]
  • Progression-Free Survival (PFS) [ Time Frame: a minimum of approximately 3 months ]
  • Duration of Response (DoR) [ Time Frame: a minimum of approximately 3 months ]
  • Time to Response (TTR) [ Time Frame: a minimum of approximately 3 months ]
  • Duration of Complete Response (DoCR) [ Time Frame: a minimum of approximately 3 months ]
  • Part A: Plasma concentration of BOS172738 [ Time Frame: Pre-dose on Days 1, 2, 15, and 16 of Cycle 1; Day 1 of Cycles 2, 3, and 4. 15 minutes (min); 30 min; 1, 3, 6, 8, 10, and 12 hours after the BOS1722722 dose on Days 1 and 15 of Cycle 1 (each cycle is 28 days) ]
  • Part B: Plasma concentration of BOS172738 [ Time Frame: Pre-dose on Day 1 of Cycles 2, 3, and 4 (each cycle is 28 days) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Efficacy, and Tolerability of BOS172738 in Patients With Advanced Rearranged During Transfection (RET) Gene-Altered Tumors
Official Title  ICMJE A Phase 1 Study of BOS172738 in Patients With Advanced Solid Tumors With RET Gene Alterations Including Non-Small Cell Lung Cancer (NSCLC) and Medullary Thyroid Cancer (MTC)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Nonhaematologic Malignancies
Intervention  ICMJE Drug: BOS172738
Oral capsules
Study Arms  ICMJE Experimental: BOS172738
In Part A (dose escalation), participants with advanced solid tumors with rearranged during transfection (RET) gene alterations will receive oral BOS172738 at a starting dose of 10 milligrams (mg) once daily in each 28-day cycle. In Part B (dose expansion), participants with RET gene-fusion non-small cell lung cancer (NSCLC), with RET gene-mutant medullary thyroid cancer (MTC), and with RET gene-altered advanced tumors or NSCLC/MTC with prior specific RET gene-targeted therapy will be enrolled in Cohorts 1, 2, and 3, respectively, and will receive oral BOS172738 once daily in each 28-day cycle at the recommended Phase 2 dose (RP2D) established in Part A.
Intervention: Drug: BOS172738
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 17, 2018)
114
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2021
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ibrahim Bello +44 131 624 0670 BOS172738-01@precisionformedicine.com
Listed Location Countries  ICMJE Belgium,   France,   Hong Kong,   Korea, Republic of,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03780517
Other Study ID Numbers  ICMJE BOS172738-01
2018-002612-27 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Pharmaceuticals
Study Sponsor  ICMJE Boston Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boston Pharmaceuticals
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP