Solid TumorsPhase 1NCT02608125
A Dose Escalation Study in Solid Tumors and a Dose Expansion Study of PRN1371 in Adult Patients With Metastatic Urothelial Carcinoma
A Phase 1 study testing PRN1371 in people with Solid Tumors and Metastatic Urothelial Carcinoma & Renal Pelvis & Ureter, run by Principia Biopharma, a Sanofi Company at 12 sites in 2 countries.
Trial summary
This is a multi-center, open label, non-randomized Phase 1 study, to be conducted in two parts, Part A, and Part B. Part A in solid tumors included the dose escalation phase for evaluating the safety and tolerability profile of PRN1371, a FGFR 1-4 Kinase inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Metastatic Urothelial Carcinoma & Renal Pelvis & Ureter
- What is being tested?
- PRN1371
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 28 Oct 2015to 23 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
- Age ≥ 18 years
- Histological or cytological documentation of an advanced solid tumor
- Subject must have metastatic or recurrent disease and have failed first-line systemic treatment, and if indicated, failed approved second-line therapy, and for whom no standard therapy options are anticipated to result in a durable remission
- Subject must have evaluable, progressive, and measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, Version 1.1
- Adequate bone marrow, liver, and renal function
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- For Part B (expansion) in subjects metastatic urothelial carcinoma:
- The patient's tumor has been evaluated and prospectively identified as having FGFR 1, 2, 3, or 4 genetic alterations.
Who cannot join
- Patients who have received adequate prior treatment with a highly selective FGFR inhibitor
- Patients with other major uncontrolled medical conditions, e.g., recent myocardial infarction, stroke, diabetes, active hepatitis
- Patients who have received prior systemic anticancer therapy ≤ 3 weeks prior to study start (6 weeks for nitrosourea, antibodies, or mitomycin-C)
- Patients diagnosed with another primary malignancy within 3 years prior to study start, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, or other non-melanomatous skin cancer, or carcinoma in situ of the uterine cervix
- Patients with glioblastoma multiforme
- Patient has a primary neoplasm of the brain or known uncontrolled metastases to the central nervous system (CNS).
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Spain7 sites
Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron University Hospital
Barcelona, 08035
Hospital General Universitario de Elche
Elche, 03203
Hospital Universitario Ramon y Cajal
Madrid, 28034
START Madrid-FJD Fundacion Jiminez Diaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
START Madrid-CIOCC, Centro Integral Oncológico Clara Campal
Madrid, 28050
Hospital Virgen del Rocio
Seville, 41013
United States5 sites
Johns Hopkins Medicine
Baltimore, Maryland, 21205
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Tennessee Oncology, Sarah Canon Research Institute
Nashville, Tennessee, 37203
UCSF Helen Diller Family Comprehensive Cancer Cener
San Francisco, California, 94115
Wake Forest University Health Sciences Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase I Open-Label, Multicenter, Dose-Escalation Study of PRN1371, a FGFR 1-4 Kinase Inhibitor, in Adult Patients With Advanced Solid Tumors, Followed by an Expansion Cohort in Patients With Metastatic Urothelial Carcinoma With FGFR 1, 2, 3, or 4 Genetic Alterations
This is a multi-center, open label, non-randomized Phase 1 study, to be conducted in two parts, Part A, and Part B. Part A in solid tumors included the dose escalation phase for evaluating the safety and tolerability profile of PRN1371, a FGFR 1-4 Kinase inhibitor. Part B is the Cohort Expansion phase in patients with metastatic urothelial carcinoma to further evaluate safety and tolerability, preliminary activity, PK, and PD in patients with FGFR genetic alterations.
Read the detailed description
The protocol specifies rules for dose-limiting toxicity and a maximum tolerated dose (MTD). To gain further experience with the MTD, and/or at some lower optimal biologic dose level, an expansion cohort (Part B) enrolled patients with metastatic urothelial carcinoma with fibroblast growth factor receptor (FGFR) 1, 2, 3 or 4 genetic alterations.
- Being tested
- PRN1371
- Keywords
- FGFR
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRN1371Drug
| Study group | Role | What they receive |
|---|---|---|
| PRN1371 | Experimental | Drug: PRN1371 Receives: Drug: PRN1371 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment related Grade 3 and/or Grade 4 adverse events, defined as dose limiting toxicities, for the doses of PRN1371
Measured: 28 days on average
Secondary outcomes (8)
Pharmacokinetic profile of PRN1371 including area under the serum concentration-time curve
Measured: Days 1 and 15
Pharmacokinetic profile of PRN1371 including maximum serum concentration
Measured: Days 1 and 15
Pharmacokinetic profile of PRN1371 including time to maximum serum concentration
Measured: Days 1 and 15
Pharmacodynamic profile of PRN1371 including the effect of PRN1371 on phosphate levels
Measured: While being treated with PRN1371 (expected average of 16 weeks)
Pharmacodynamic profile of PRN1371 including the effect of PRN1371 on calcium levels
Measured: While being treated with PRN1371 (expected average of 16 weeks)
Pharmacodynamic profile of PRN1371 including the effect of PRN1371 on serum FGF23 (Part A only) levels
Measured: While being treated with PRN1371 (expected average of 16 weeks)
Objective response rate (ORR) as measured by RECIST v1.1 in patients treated with PRN1371
Measured: Every 8 weeks while being treated with PRN1371 (expected average of 16 weeks)
Duration of response in patients treated with PRN1371
Measured: Every 8 weeks while being treated with PRN1371 (expected average 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study start28 Oct 2015
- Primary completion23 Jun 2020
- Study completion23 Jun 2020
Why it stopped: focus portfolio on immune-mediated diseases
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Principia Biopharma, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608125
- Sponsor's protocol ID
- PRN1371-001
- Status last verified
- Dec 2020
- First submitted
- 18 Sep 2015
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label, Multicenter, Dose-Escalation Study of PRN1371, a FGFR 1-4 Kinase Inhibitor, in Adult Patients With Advanced Solid Tumors, Followed by an Expansion Cohort in Patients With Metastatic Urothelial Carcinoma With FGFR 1, 2, 3, or 4 Genetic Alterations
- ClinicalTrials.gov ID
- NCT02608125
- Acronym / sponsor ID
- PRN1371-001
- Keywords
- FGFR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: focus portfolio on immune-mediated diseases
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Principia Biopharma, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2015 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 18 Nov 2015 (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 is a multi-center, open label, non-randomized Phase 1 study, to be conducted in two parts, Part A, and Part B. Part A in solid tumors included the dose escalation phase for evaluating the safety and tolerability profile of PRN1371, a FGFR 1-4 Kinase inhibitor. Part B is the Cohort Expansion phase in patients with metastatic urothelial carcinoma to further evaluate safety and tolerability, preliminary activity, PK, and PD in patients with FGFR genetic alterations.
Detailed description
The protocol specifies rules for dose-limiting toxicity and a maximum tolerated dose (MTD). To gain further experience with the MTD, and/or at some lower optimal biologic dose level, an expansion cohort (Part B) enrolled patients with metastatic urothelial carcinoma with fibroblast growth factor receptor (FGFR) 1, 2, 3 or 4 genetic alterations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRN1371 | Experimental | Drug: PRN1371Drug: PRN1371 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Histological or cytological documentation of an advanced solid tumor
- Subject must have metastatic or recurrent disease and have failed first-line systemic treatment, and if indicated, failed approved second-line therapy, and for whom no standard therapy options are anticipated to result in a durable remission
- Subject must have evaluable, progressive, and measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, Version 1.1
- Adequate bone marrow, liver, and renal function
Key exclusion criteria (6 listed)
- Patients who have received adequate prior treatment with a highly selective FGFR inhibitor
- Patients with other major uncontrolled medical conditions, e.g., recent myocardial infarction, stroke, diabetes, active hepatitis
- Patients who have received prior systemic anticancer therapy ≤ 3 weeks prior to study start (6 weeks for nitrosourea, antibodies, or mitomycin-C)
- Patients diagnosed with another primary malignancy within 3 years prior to study start, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, or other non-melanomatous skin cancer, or carcinoma in situ of the uterine cervix
- Patients with glioblastoma multiforme
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 |
|---|---|---|
| PRN1371 | Drug | PRN1371 |
Primary outcome
Incidence of treatment related Grade 3 and/or Grade 4 adverse events, defined as dose limiting toxicities, for the doses of PRN1371
Time frame: 28 days on average
8 secondary outcomes
Pharmacokinetic profile of PRN1371 including area under the serum concentration-time curve
Time frame: Days 1 and 15
Pharmacokinetic profile of PRN1371 including maximum serum concentration
Time frame: Days 1 and 15
Pharmacokinetic profile of PRN1371 including time to maximum serum concentration
Time frame: Days 1 and 15
Pharmacodynamic profile of PRN1371 including the effect of PRN1371 on phosphate levels
Time frame: While being treated with PRN1371 (expected average of 16 weeks)
Pharmacodynamic profile of PRN1371 including the effect of PRN1371 on calcium levels
Time frame: While being treated with PRN1371 (expected average of 16 weeks)
Pharmacodynamic profile of PRN1371 including the effect of PRN1371 on serum FGF23 (Part A only) levels
Time frame: While being treated with PRN1371 (expected average of 16 weeks)
Objective response rate (ORR) as measured by RECIST v1.1 in patients treated with PRN1371
Time frame: Every 8 weeks while being treated with PRN1371 (expected average of 16 weeks)
Duration of response in patients treated with PRN1371
Time frame: Every 8 weeks while being treated with PRN1371 (expected average 16 weeks)
Results and safety
The study was stopped early (reason given: focus portfolio on immune-mediated diseases). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
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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.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRN1371 in people with Solid Tumors and Metastatic Urothelial Carcinoma & Renal Pelvis & Ureter, run by Principia Biopharma, a Sanofi Company at 12 sites in 2 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 8 inclusion and 6 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 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain, United States. 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 (reason given: focus portfolio on immune-mediated diseases). 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?
Incidence of treatment related Grade 3 and/or Grade 4 adverse events, defined as dose limiting toxicities, for the doses of PRN1371 (time frame: 28 days on average). 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 24 Dec 2020.