TerminatedPhase 1

Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations

United States, Singapore, South Korea77 participantsStarted 2013-08

Plain-language summary

This study is primarily designed to assess the safety and the tolerability of Debio1347 (CH5183284) in patients with advanced solid malignancies, whose tumours have an alteration of the Fibroblast Growth Factor Receptor (FGFR) 1, 2 or 3 genes, for whom standard treatment does not exist or is not indicated. The main objective of Part A is to identify the dose-limiting toxicities (DLTs) and estimate the maximum tolerated dose (MTD) based on the safety and tolerability of Debio1347 orally administered daily to these patients, in order to determine the recommended dose. The main objective of Part B is to evaluate the safety profile at the recommended dose, in a larger cohort of these patients.

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.

Exclusion criteria

. the safety or well-being of the participant or study staff
. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
. the analysis of results

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

Part A: Percentage of Participants With Dose-Limiting Toxicities (DLTs) From Debio 1347

Timeframe: within approximately 18 months

Part B: Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)

Timeframe: within 2 years of starting treatment

Part B: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

Timeframe: within 2 years of starting treatment

Part B: Severity of Treatment-Emergent AEs

Timeframe: within 2 years of starting treatment

Part B: Severity of Laboratory Abnormalities

Timeframe: within 2 years of starting treatment

Trial details

NCT IDNCT01948297

SponsorDebiopharm International SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-06-26

View on ClinicalTrials.gov More Solid Tumours trials

Plain-language summary

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.

Exclusion criteria

. the safety or well-being of the participant or study staff
. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
. the analysis of results

What they're measuring

Part A: Percentage of Participants With Dose-Limiting Toxicities (DLTs) From Debio 1347

Timeframe: within approximately 18 months

Part B: Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)

Timeframe: within 2 years of starting treatment

Part B: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

Timeframe: within 2 years of starting treatment

Part B: Severity of Treatment-Emergent AEs

Timeframe: within 2 years of starting treatment

Part B: Severity of Laboratory Abnormalities

Timeframe: within 2 years of starting treatment