Advanced Nonhaematologic MalignanciesPhase 1NCT03780517
Safety, Efficacy, and Tolerability of BOS172738 in Patients With Advanced Rearranged During Transfection (RET) Gene-Altered Tumors
A Phase 1 study testing BOS172738 in people with Advanced Nonhaematologic Malignancies, run by Boston Pharmaceuticals at 21 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Nonhaematologic Malignancies
- What is being tested?
- BOS172738
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 21 sitesin 7 countries
- Study dates
- 12 Dec 2018to 26 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
21 sites in 7 countries.
21 sites in 7 countries
South Korea5 sites
Chungbuk National University Hospital
Cheongju-si
Seoul National University Bundang Hospital
Gyeonggi-do
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Severance Hospital, Yonsei University College of Medicine
Seoul
Spain5 sites
Hospital Germans Trias i Pujol
Badalona
Instituto Oncológico Dr. Rosell, S.L.
Barcelona
Start Madrid - Ciocc
Madrid
START MADRID-FJD, Hospital Fundación Jiménez Díaz
Madrid
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, 29010
France4 sites
Institut Bergonié
Bordeaux
Centre Léon Bérard
Lyon
Hôpital Pitié-Salpêtrière
Paris
Institut Gustave Roussy
Villejuif
United States2 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Taiwan2 sites
Taichung Veterans General Hospital
Taichung
National Taiwan University Hospital
Taipei
About this study
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)
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.
- Conditions
- Advanced Nonhaematologic Malignancies
- Being tested
- BOS172738
- Keywords
- BOS172738, RET gene, Medullary Thyroid Cancer, Non-Small Cell Lung Cancer
- Medical subject headings
- Multiple Endocrine Neoplasia Type 2a, Carcinoma, Medullary, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOS172738Drug
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| BOS172738 | Experimental | 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. Receives: Drug: BOS172738 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with any treatment-emergent (TE) serious adverse event (SAE)
Measured: a minimum of approximately 3 months
Number of participants with any non-serious TEAE
Measured: a minimum of approximately 3 months
Number of participants with grade 3, grade 4, or grade 5 TEAEs
Measured: a minimum of approximately 3 months
Number of participants with any related TEAE
Measured: a minimum of approximately 3 months
Number of participants with any TEAE leading to study drug discontinuation
Measured: a minimum of approximately 3 months
Maximum tolerated dose (MTD) of BOS172738
Measured: throughout Cycle 1 (each cycle is 28 days)
Recommended phase 2 dose (RP2D) of BOS172738
Measured: 28-day cycles in Part A (minimum of one dose of BOS172738 received)
Secondary outcomes (8)
Objective Response Rate (ORR)
Measured: a minimum of approximately 3 months
Objective Disease Control Rate (ODCR)
Measured: a minimum of approximately 3 months
Progression-Free Survival (PFS)
Measured: a minimum of approximately 3 months
Duration of Response (DoR)
Measured: a minimum of approximately 3 months
Time to Response (TTR)
Measured: a minimum of approximately 3 months
Duration of Complete Response (DoCR)
Measured: a minimum of approximately 3 months
Part A: Plasma concentration of BOS172738
Measured: 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
Measured: Pre-dose on Day 1 of Cycles 2, 3, and 4 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start12 Dec 2018
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Nonhaematologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780517
- Sponsor's protocol ID
- BOS172738-01
- Other IDs
- 2018-002612-27, 2018
- Status last verified
- Oct 2023
- First submitted
- 12 Dec 2018
- Last updated
- 30 Oct 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03780517
- Acronym / sponsor ID
- BOS172738-01
- Conditions
- Advanced Nonhaematologic Malignancies
- Keywords
- BOS172738, RET gene, Medullary Thyroid Cancer, Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Boston PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BOS172738 | Experimental | Drug: BOS172738In 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOS172738Oral capsules | Drug | BOS172738 |
Primary outcome
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)
8 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BOS172738 in people with Advanced Nonhaematologic Malignancies, run by Boston Pharmaceuticals at 21 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in South Korea, Spain, France, United States, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with any treatment-emergent (TE) serious adverse event (SAE) (time frame: a minimum of approximately 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.