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A Dose Escalation Study in Solid Tumors and a Dose Expansion Study of PRN1371 in Adult Patients With Metastatic Urothelial Carcinoma

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ClinicalTrials.gov Identifier: NCT02608125
Recruitment Status : Recruiting
First Posted : November 18, 2015
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Principia Biopharma Inc.

Brief 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 is 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.

Condition or disease Intervention/treatment Phase
Solid Tumors Metastatic Urothelial Carcinoma & Renal Pelvis & Ureter Drug: PRN1371 Phase 1

Detailed Description:
The study is a dose escalation study. 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) will be enrolled in patients with metastatic urothelial carcinoma with fibroblast growth factor receptor (FGFR) 1, 2, 3 or 4 genetic alterations.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PRN1371
Drug: PRN1371
Drug: PRN1371



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pharmacokinetic profile of PRN1371 including area under the serum concentration-time curve [ Time Frame: Days 1 and 15 ]
  2. Pharmacokinetic profile of PRN1371 including maximum serum concentration [ Time Frame: Days 1 and 15 ]
  3. Pharmacokinetic profile of PRN1371 including time to maximum serum concentration [ Time Frame: Days 1 and 15 ]
  4. Pharmacodynamic profile of PRN1371 including the effect of PRN1371 on phosphate levels [ Time Frame: While being treated with PRN1371 (expected average of 16 weeks) ]
  5. Pharmacodynamic profile of PRN1371 including the effect of PRN1371 on calcium levels [ Time Frame: While being treated with PRN1371 (expected average of 16 weeks) ]
  6. Pharmacodynamic profile of PRN1371 including the effect of PRN1371 on serum FGF23 levels [ Time Frame: While being treated with PRN1371 (expected average of 16 weeks) ]
  7. 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) ]
  8. Duration of response in patients treated with PRN1371 [ Time Frame: Every 8 weeks while being treated with PRN1371 (expected average 16 weeks) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608125


Contacts
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Contact: Ann Neale, RN BSN +16504167784 clinicaltrials@principiabio.com
Contact: Chris Resburg +16504167777 clinicaltrials@principiabio.com

Locations
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United States, California
UCSF Helen Diller Family Comprehensive Cancer Cener Completed
San Francisco, California, United States, 94115
United States, Maryland
Johns Hopkins Medicine Recruiting
Baltimore, Maryland, United States, 21205
Contact: Noah Hahn, MD       nhahn4@jhmi.edu   
United States, North Carolina
Wake Forest University Health Sciences Medical Center Active, not recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Tennessee
Tennessee Oncology, Sarah Canon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Todd Bauer       tbauer@tnonc.com   
Principal Investigator: Todd Bauer, MD         
United States, Texas
The University of Texas MD Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
Spain
Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron University Hospital Active, not recruiting
Barcelona, Spain, 08035
START Madrid-FJD Fundacion Jiminez Diaz Active, not recruiting
Madrid, Spain, 28040
START Madrid-CIOCC, Centro Integral Oncológico Clara Campal Active, not recruiting
Madrid, Spain, 28050
Sponsors and Collaborators
Principia Biopharma Inc.
Investigators
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Study Director: Dolca Thomas, MD Principia Biopharma

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Responsible Party: Principia Biopharma Inc.
ClinicalTrials.gov Identifier: NCT02608125     History of Changes
Other Study ID Numbers: PRN1371-001
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

Keywords provided by Principia Biopharma Inc.:
FGFR

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms