Solid TumoursPhase 1NCT01948297
Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations
A Phase 1 study testing Debio1347 (CH5183284) in people with Solid Tumours, run by Debiopharm International SA at 8 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumours
- What is being tested?
- Debio1347 (CH5183284)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Aug 2013to 26 Jun 2020
- 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
- Meets protocol-specified criteria for qualification and contraception
- Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
- Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Who cannot join
- Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- 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
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
United States4 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02114
Massachusetts General Hospital
Boston, Massachusetts, 02215
The University of Texas; MD Anderson Cancer Center
Houston, Texas, 77030-4009
Memorial Sloan-Kettering Hospital
New York, New York, 10065
About this study
Official title: A Phase I, Gene Alteration-based, Open Label, Multicenter Study of Oral Debio 1347 (CH5183284) in Patients With Advanced Solid Malignancies, Whose Tumours Have an Alteration of the FGFR 1, 2 or 3 Genes
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.
- Conditions
- Solid Tumours
- Being tested
- Debio1347 (CH5183284)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debio1347 (CH5183284)Drug
Also called CH5183284
Debio1347 (CH5183284) tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Adaptive doses of Debio1347 (CH5183284) - (10 mg to 210 mg/day) until the recommended dose (RD) is determined. Receives: Drug: Debio1347 (CH5183284) |
| Part B | Experimental | Participants with various tumours receive Debio1347 (CH5183284) orally at the recommended dose established during Part A. Receives: Drug: Debio1347 (CH5183284) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Percentage of Participants With Dose-Limiting Toxicities (DLTs) From Debio 1347
Measured: within approximately 18 months
Part B: Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Measured: within 2 years of starting treatment
Part B: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Measured: within 2 years of starting treatment
Part B: Severity of Treatment-Emergent AEs
Categories: NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4 severity criteria
Measured: within 2 years of starting treatment
Part B: Severity of Laboratory Abnormalities
Categories: NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4 severity criteria
Measured: within 2 years of starting treatment
Secondary outcomes (37)
Part A: Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Measured: within 2 years of starting treatment
Part A: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Measured: within 2 years of starting treatment
Part A: Severity of Treatment-Emergent AEs
Categories: NCI-CTCAE version 4 severity criteria
Measured: within 2 years of starting treatment
Part A: Severity of Laboratory Abnormalities
Categories: NCI-CTCAE version 4 severity criteria
Measured: within 2 years of starting treatment
Part A and Part B: Percentage of Participants With Treatment Discontinuations or Modifications due to AEs and Laboratory Abnormalities
Measured: within 2 years of starting treatment
Part A and Part B: Number of Participants With Change From Baseline in Blood Pressure (BP)
Change in BP will be evaluation based on three criteria- "Change to Low" (decrease from pre-treatment > 20 millimeter of mercury [mmHg]), "No change" (change from pre-treatment within ± 20 mmHg) and "Change to High" (increase from pre-treatment > 20 mmHg).
Measured: within 2 years of starting treatment
Part A and Part B: Number of Participants With Change From Baseline in Pulse Rate
Number of participants with change of more than 20 beats per minute from baseline will be reported.
Measured: within 2 years of starting treatment
Part A and Part B: Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters
ECG parameters will include PR, RR, QRS, QTcB and QTcF intervals.
Measured: within 2 years of starting treatment
Part A and Part B: Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Measured: within 2 years of starting treatment
Part A and Part B: Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Measured: within 2 years of starting treatment
Part A: Number of Participants With Tumour Response, According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 Criteria
Includes: Best overall response, disease control, tumour size
Measured: within 2 years of starting treatment
Part B: Number of Participants With Tumour Response, According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 Citeria or Response Assessment in Neuro-Oncology (RANO) (for glioblastoma participants)
Includes: Best overall response, disease control, tumour size
Measured: within 2 years of starting treatment
Part A and Part B: Progression-Free Survival Rate After Treatment Initiation
Categories: overall, 6 months, 1 year, 2 years
Measured: within 2 years of starting treatment
Part A and Part B: Number of Participants With Changes in Ophthalmological Exams
Opthalmological exams includes visual acuity testing, slit-lamp ophthalmoscopy and indirect ophthalmoscopy.
Measured: within 2 years of starting treatment
Part A: Area Under Concentration-Time Curve (AUC) Following Single- and Repeated-Dose Administration of Debio 1347
Measured: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Concentration at the end of a Dosing Interval (Ctrough) Following Single- and Repeated-Dose Administration of Debio 1347
Measured: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Maximum Observed Concentration (Cmax) Following Single- and Repeated-Dose Administration of Debio 1347
Measured: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Time of Maximum Concentration (tmax) Following Single- and Repeated-Dose Administration of Debio 1347
Measured: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Apparent Terminal Half-Life (t1/2) Following Single- and Repeated-Dose Administration of Debio 1347
Measured: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Mean Residence Time (MRT) Following Single- and Repeated-Dose Administration of Debio 1347
Measured: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Apparent Clearance (CL/F) Following Single- and Repeated-Dose Administration of Debio 1347
Measured: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Apparent Volume of Distribution (Vz/F) Following Single- and Repeated-Dose Administration of Debio 1347
Measured: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Accumulation Ratios (RAC) Following Single- and Repeated-Dose Administration of Debio 1347
Measured: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Linearity Index (LI) Following Single- and Repeated-Dose Administration of Debio 1347
Measured: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Peak-to-Trough fluctuation (PTF) Following Single- and Repeated-Dose Administration of Debio 1347
Measured: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part B: Area Under Concentration-Time Curve (AUC), Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Measured: Day 28
Part B: Concentration at the end of a Dosing Interval (Ctrough) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Measured: Day 28
Part B: Maximum Observed Concentration (Cmax) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Measured: Day 28
Part B: Time of Maximum Concentration (tmax) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Measured: Day 28
Part B: Apparent Terminal Half-Life (t1/2) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Measured: Day 28
Part B: Mean Residence Time (MRT) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Measured: Day 28
Part B: Apparent clearance (CL/F) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Measured: Day 28
Part B: Apparent Volume of Distribution (Vz/F) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Measured: Day 28
Part B: Peak-to-Trough Fluctuation (PTF) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Measured: Day 28
Part B: Renal Clearance (CLR) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Measured: Day 28
Part B: Percentage of the Dose Excreted in Urine (Ae%) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Measured: Day 28
Part B: Ctrough in all Participants
Measured: Day 8, Day 15, Day 22 of Cycle 1, and Day 1 of Cycle 2 and Cycle 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startAug 2013
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumoursStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948297
- Sponsor's protocol ID
- Debio 1347-101
- Other IDs
- 2013-000316-19
- Status last verified
- Sep 2020
- First submitted
- 26 Aug 2013
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Gene Alteration-based, Open Label, Multicenter Study of Oral Debio 1347 (CH5183284) in Patients With Advanced Solid Malignancies, Whose Tumours Have an Alteration of the FGFR 1, 2 or 3 Genes
- ClinicalTrials.gov ID
- NCT01948297
- Acronym / sponsor ID
- Debio 1347-101
- Conditions
- Solid Tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Debiopharm International SAIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 23 Sep 2013 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Debio1347 (CH5183284)Adaptive doses of Debio1347 (CH5183284) - (10 mg to 210 mg/day) until the recommended dose (RD) is determined. |
| Part B | Experimental | Drug: Debio1347 (CH5183284)Participants with various tumours receive Debio1347 (CH5183284) orally at the recommended dose established during Part A. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets protocol-specified criteria for qualification and contraception
- Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
- Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Key exclusion criteria (5 listed)
- Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
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 |
|---|---|---|
| Debio1347 (CH5183284)Also: CH5183284Debio1347 (CH5183284) tablets for oral administration | Drug | Part A, Part B |
Primary outcome
Part A: Percentage of Participants With Dose-Limiting Toxicities (DLTs) From Debio 1347
Time frame: within approximately 18 months
Part B: Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Time frame: within 2 years of starting treatment
Part B: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: within 2 years of starting treatment
Part B: Severity of Treatment-Emergent AEs
Time frame: within 2 years of starting treatment
Categories: NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4 severity criteria
Part B: Severity of Laboratory Abnormalities
Time frame: within 2 years of starting treatment
Categories: NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4 severity criteria
37 secondary outcomes
Part A: Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Time frame: within 2 years of starting treatment
Part A: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: within 2 years of starting treatment
Part A: Severity of Treatment-Emergent AEs
Time frame: within 2 years of starting treatment
Part A: Severity of Laboratory Abnormalities
Time frame: within 2 years of starting treatment
Part A and Part B: Percentage of Participants With Treatment Discontinuations or Modifications due to AEs and Laboratory Abnormalities
Time frame: within 2 years of starting treatment
Part A and Part B: Number of Participants With Change From Baseline in Blood Pressure (BP)
Time frame: within 2 years of starting treatment
Part A and Part B: Number of Participants With Change From Baseline in Pulse Rate
Time frame: within 2 years of starting treatment
Part A and Part B: Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame: within 2 years of starting treatment
Part A and Part B: Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Time frame: within 2 years of starting treatment
Part A and Part B: Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Time frame: within 2 years of starting treatment
Part A: Number of Participants With Tumour Response, According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 Criteria
Time frame: within 2 years of starting treatment
Part B: Number of Participants With Tumour Response, According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 Citeria or Response Assessment in Neuro-Oncology (RANO) (for glioblastoma participants)
Time frame: within 2 years of starting treatment
Part A and Part B: Progression-Free Survival Rate After Treatment Initiation
Time frame: within 2 years of starting treatment
Part A and Part B: Number of Participants With Changes in Ophthalmological Exams
Time frame: within 2 years of starting treatment
Part A: Area Under Concentration-Time Curve (AUC) Following Single- and Repeated-Dose Administration of Debio 1347
Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Concentration at the end of a Dosing Interval (Ctrough) Following Single- and Repeated-Dose Administration of Debio 1347
Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Maximum Observed Concentration (Cmax) Following Single- and Repeated-Dose Administration of Debio 1347
Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Time of Maximum Concentration (tmax) Following Single- and Repeated-Dose Administration of Debio 1347
Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Apparent Terminal Half-Life (t1/2) Following Single- and Repeated-Dose Administration of Debio 1347
Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Mean Residence Time (MRT) Following Single- and Repeated-Dose Administration of Debio 1347
Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Apparent Clearance (CL/F) Following Single- and Repeated-Dose Administration of Debio 1347
Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Apparent Volume of Distribution (Vz/F) Following Single- and Repeated-Dose Administration of Debio 1347
Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Accumulation Ratios (RAC) Following Single- and Repeated-Dose Administration of Debio 1347
Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Linearity Index (LI) Following Single- and Repeated-Dose Administration of Debio 1347
Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part A: Peak-to-Trough fluctuation (PTF) Following Single- and Repeated-Dose Administration of Debio 1347
Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3
Part B: Area Under Concentration-Time Curve (AUC), Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Time frame: Day 28
Part B: Concentration at the end of a Dosing Interval (Ctrough) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Time frame: Day 28
Part B: Maximum Observed Concentration (Cmax) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Time frame: Day 28
Part B: Time of Maximum Concentration (tmax) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Time frame: Day 28
Part B: Apparent Terminal Half-Life (t1/2) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Time frame: Day 28
Part B: Mean Residence Time (MRT) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Time frame: Day 28
Part B: Apparent clearance (CL/F) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Time frame: Day 28
Part B: Apparent Volume of Distribution (Vz/F) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Time frame: Day 28
Part B: Peak-to-Trough Fluctuation (PTF) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Time frame: Day 28
Part B: Renal Clearance (CLR) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Time frame: Day 28
Part B: Percentage of the Dose Excreted in Urine (Ae%) Following Repeated-Dose Administration of Debio 1347 in the PK Subset
Time frame: Day 28
Part B: Ctrough in all Participants
Time frame: Day 8, Day 15, Day 22 of Cycle 1, and Day 1 of Cycle 2 and Cycle 3
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Related InfoLink provided by the sponsor.
Related trials for Solid Tumours
Active, not recruiting
A Collaborative Intervention for Improving Cancer Pain Management in Cancer Survivors
Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
Active, not recruitingPhase 1
Research Study Utilizing Expanded Multi-antigen Specific Lymphocytes for the Treatment of Solid Tumors
Solid Tumors
RecruitingObservational study
Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors
Malignant Solid Tumors, Other Neoplasms Solid Tumors
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
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.
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Debio1347 (CH5183284) in people with Solid Tumours, run by Debiopharm International SA at 8 sites in 5 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Singapore, South Korea, Spain, Taiwan. 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 was stopped early. Results are not available in the source record.
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?
Part A: Percentage of Participants With Dose-Limiting Toxicities (DLTs) From Debio 1347 (time frame: within approximately 18 months). The study lists 5 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 9 Sep 2020.