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Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02318329
Recruitment Status : Active, not recruiting
First Posted : December 17, 2014
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Five Prime Therapeutics, Inc.

Brief Summary:
This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors - No Longer Enrolling Gastric Cancer - No Longer Enrolling Transitional Cell Carcinoma of the Genitourinary Tract (Bladder Cancer) - No Longer Enrolling Drug: FPA144 Phase 1

Detailed Description:

Part 1A is a dose-escalation study in patients with any locally advanced or metastatic solid tumor or lymphoma for which standard therapies have been exhausted. Part 1B will further assess safety and evaluate PK of FPA144 in gastric cancer patients.

Part 2 patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in a selected cancer patient population with the greatest potential for clinical benefit from FPA144 treatment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open-Label, Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Patients With Advanced Solid Tumors
Study Start Date : November 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : March 2019


Arm Intervention/treatment
Experimental: Part 1A: FPA144 Dose Escalation Solid Tumors
IV infusion; safety data will be reviewed prior to dose escalation decision. Dose escalation will complete when recommended dose (RD) is determined.
Drug: FPA144
FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
Other Name: anti-hFGFR2b receptor antibody

Experimental: Part 1B: FPA144 Dose Escalation Gastric Cancer
IV infusion; safety data will be reviewed prior to dose escalation decision. Dose escalation will complete when recommended dose (RD) is determined.
Drug: FPA144
FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
Other Name: anti-hFGFR2b receptor antibody

Experimental: Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors

Part 2: FPA144 Dose Expansion Gastric, Bladder or Other Advanced Solid Tumors

The study is not currently enrolling patients. Cohorts with Advanced Solid Tumors, Gastric Cancer and Bladder Cancer are closed. IV infusion; once MTD and/or RD has been determined in Part 1, one expansion cohort of approximately 30 Bladder Cancer patients will be enrolled.

Drug: FPA144
FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
Other Name: anti-hFGFR2b receptor antibody




Primary Outcome Measures :
  1. Incidence of Grade 3 and Grade 4 adverse events (AEs) and clinical laboratory abnormalities defined as dose-limiting toxicities (Part 1 only). [ Time Frame: 4 weeks on average ]
  2. Incidence of AEs and clinical laboratory abnormalities (Parts 1B and 2 only) [ Time Frame: 16 weeks on average ]

Secondary Outcome Measures :
  1. Pharmacokinetic profile of FPA144 (area under serum concentration-time curve, maximum serum concentration, minimum serum concentration, clearance, and volume of distribution at steady-state ): [ Time Frame: 16 weeks on average ]

    Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2.

    • The incidence of AEs, clinical laboratory abnormalities, retinal findings, and ECG abnormalities


  2. Pharmacokinetic profile of FPA144 (area under serum concentration-time curve, maximum serum concentration, minimum serum concentration, clearance, and volume of distribution at steady-state ): [ Time Frame: 16 weeks on average ]
    Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2.

  3. Objective response rate (ORR) per RECIST 1.1 (Part 2 only) [ Time Frame: 16 weeks on average ]
  4. Duration of response per RECIST 1.1 (Part 2 only) [ Time Frame: 16 weeks on average ]
  5. Pharmacodynamic profile of FPA144 through an analysis of the immune cell infiltrate in pre-treatment and on-treatment tumor biopsies by tumor type (Part 2 only) [ Time Frame: 16 weeks on average ]


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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:

  • Life expectancy of at least 3 months
  • ECOG performance status of 0 to 1

    • In sexually-active patients, willingness to use 2 effective methods of contraception

  • Adequate hematological and organ function, confirmed by lab values
  • Tumor tissue must be available for prospective determination of FGFR2b overexpression

    • Locally recurrent or metastatic disease that has progressed on or following standard treatment, or is not a candidate for standard treatment
    • Histologically or cytologically confirmed transitional cell carcinoma of the genitourinary tract
    • Measurable disease as defined by RECIST version 1.1

Exclusion Criteria:

  • Untreated or symptomatic central nervous system (CNS) metastases
  • Impaired cardiac function or clinically significant cardiac disease

    - Treatment with any anticancer therapy or participation in another therapeutic clinical study with investigational drugs </=14 days (</=28 days for patients in Korea) prior to first dose of FPA144

  • Ongoing acute adverse effects from prior anticancer or investigational therapy > NCI CTCAE Grade 1
  • Retinal disease or a history of retinal disease or detachment
  • Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal transplant, or other known abnormalities of the cornea
  • Major surgical procedures are not allowed ≤28 days prior to FPA144 administration
  • Females who are pregnant or breastfeeding; women of childbearing potential must not be considering getting pregnant during the study

    - Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study

  • Known allergy or hypersensitivity to components of the FPA144 formulation including polysorbate
  • History of prior malignancy except:
  • a) Curatively treated non-melanoma skin cancer or
  • b) Solid tumor treated curatively more than 5 years previously without evidence of recurrence or
  • c) History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect
  • Prior treatment with any selective inhibitor (e.g., AZD4547, BGJ398, JNJ-42756493, BAY1179470) of the FGF-FGFR pathway

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): NCT02318329


Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
UCSF Helen Diller Family Comprehensive Cancer Center, Mission Bay
San Francisco, California, United States, 74158
Innovative Cancer Research Institute
Whittier, California, United States, 90603
United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Weill Cornell Medical Center
New York, New York, United States, 10065
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030-4009
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
Korea, Republic of
Chonbuk National University Hospital
Jeonju-si, Korea, Republic of, 561-712
Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of, 463-707
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Severance Hospital, Yonsei University
Seoul, Korea, Republic of, 120-752
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Gangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of, 156-707
Taiwan
China Medical University Hospital
Taichung, Taiwan, 40447
National Cheng Kung University Hospital
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei, Taiwan, 100
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Sponsors and Collaborators
Five Prime Therapeutics, Inc.
Investigators
Study Director: Medical Lead Five Prime Therapeutics, Inc.

Responsible Party: Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02318329     History of Changes
Other Study ID Numbers: FPA144-001
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

Keywords provided by Five Prime Therapeutics, Inc.:
FGFR2b, FGFR2, FGFR, bladder neoplasms, esophageal cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type