Safety, Efficacy, and Tolerability of BOS172738 in Patients With Advanced Rearranged During Trans… (NCT03780517) | Clinical Trial Compass
CompletedPhase 1
Safety, Efficacy, and Tolerability of BOS172738 in Patients With Advanced Rearranged During Transfection (RET) Gene-Altered Tumors
United States, Belgium, France117 participantsStarted 2018-12-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with any treatment-emergent (TE) serious adverse event (SAE)
Timeframe: a minimum of approximately 3 months
2
Number of participants with any non-serious TEAE
Timeframe: a minimum of approximately 3 months
3
Number of participants with grade 3, grade 4, or grade 5 TEAEs
Timeframe: a minimum of approximately 3 months
4
Number of participants with any related TEAE
Timeframe: a minimum of approximately 3 months
5
Number of participants with any TEAE leading to study drug discontinuation
Timeframe: a minimum of approximately 3 months
6
Maximum tolerated dose (MTD) of BOS172738
Timeframe: throughout Cycle 1 (each cycle is 28 days)
7
Recommended phase 2 dose (RP2D) of BOS172738
Timeframe: 28-day cycles in Part A (minimum of one dose of BOS172738 received)