Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03780517
Previous Study | Return to List | Next Study

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 : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Advanced Nonhaematologic Malignancies Drug: BOS172738 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: BOS172738
Oral capsules




Primary Outcome Measures :
  1. Number of participants with any treatment-emergent (TE) serious adverse event (SAE) [ Time Frame: a minimum of approximately 3 months ]
  2. Number of participants with any non-serious TEAE [ Time Frame: a minimum of approximately 3 months ]
  3. Number of participants with grade 3, grade 4, or grade 5 TEAEs [ Time Frame: a minimum of approximately 3 months ]
  4. Number of participants with any related TEAE [ Time Frame: a minimum of approximately 3 months ]
  5. Number of participants with any TEAE leading to study drug discontinuation [ Time Frame: a minimum of approximately 3 months ]
  6. Maximum tolerated dose (MTD) of BOS172738 [ Time Frame: throughout Cycle 1 (each cycle is 28 days) ]
  7. Recommended phase 2 dose (RP2D) of BOS172738 [ Time Frame: 28-day cycles in Part A (minimum of one dose of BOS172738 received) ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: a minimum of approximately 3 months ]
  2. Objective Disease Control Rate (ODCR) [ Time Frame: a minimum of approximately 3 months ]
  3. Progression-Free Survival (PFS) [ Time Frame: a minimum of approximately 3 months ]
  4. Duration of Response (DoR) [ Time Frame: a minimum of approximately 3 months ]
  5. Time to Response (TTR) [ Time Frame: a minimum of approximately 3 months ]
  6. Duration of Complete Response (DoCR) [ Time Frame: a minimum of approximately 3 months ]
  7. 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) ]
  8. Part B: Plasma concentration of BOS172738 [ Time Frame: Pre-dose on Day 1 of Cycles 2, 3, and 4 (each cycle is 28 days) ]


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03780517


Contacts
Layout table for location contacts
Contact: Ibrahim Bello +44 131 624 0670 BOS172738-01@precisionformedicine.com

Locations
Layout table for location information
Belgium
Institut Jules Bordet Recruiting
Bruxelles, Belgium
UZ Leuven Recruiting
Leuven, Belgium
France
Institut Bergonié Not yet recruiting
Bordeaux, France
Institut Gustave Roussy Not yet recruiting
Villejuif, France
Spain
Instituto Oncológico Dr. Rosell, S.L. Recruiting
Barcelona, Spain
Start Madrid - Ciocc Recruiting
Madrid, Spain
START MADRID-FJD, Hospital Fundación Jiménez Díaz Recruiting
Madrid, Spain
Sponsors and Collaborators
Boston Pharmaceuticals

Layout table for additonal information
Responsible Party: Boston Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03780517     History of Changes
Other Study ID Numbers: BOS172738-01
2018-002612-27 ( EudraCT Number )
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Boston Pharmaceuticals:
BOS172738
RET gene
Medullary Thyroid Cancer
Non-Small Cell Lung Cancer