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Trial record 1 of 1 for:    NCT02318329
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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 : Completed
First Posted : December 17, 2014
Results First Posted : March 11, 2020
Last Update Posted : March 24, 2020
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 Gastric Cancer Transitional Cell Carcinoma of the Bladder 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 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
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : June 30, 2019


Arm Intervention/treatment
Experimental: Part 1A: FPA144 Dose Escalation Solid Tumors
Dose escalation of FPA144 (0.3 mg/kg to 15 mg/kg)
Drug: FPA144
FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
Other Name: Bemarituzumab

Experimental: Part 1B: FPA144 Dose Escalation Gastric Cancer
Dose escalation of FPA144 (3-10 mg/kg) in patients with gastric cancer
Drug: FPA144
FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
Other Name: Bemarituzumab

Experimental: Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors
Evaluation of objective responses in patients with tumors with various levels of FGFR2b overexpression
Drug: FPA144
FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
Other Name: Bemarituzumab




Primary Outcome Measures :
  1. Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). [ Time Frame: 4 weeks on average ]
    Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)

  2. Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only) [ Time Frame: 16 weeks on average ]
    Number of Participants with AEs and clinical laboratory abnormalities (Parts 1B and 2 only)


Secondary Outcome Measures :
  1. Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration [ 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.

    • Summary of area under serum concentration-time curve, maximum serum concentration,


  2. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: 16 weeks on average ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  3. Duration of Response Per RECIST 1.1 (Part 2 Only) [ Time Frame: 16 weeks on average ]
    Duration of complete or partial response with 95% confidence intervals in gastric cancer population.

  4. Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve [ 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.

    • Summary of area under serum concentration-time curve, maximum serum concentration,




Information from the National Library of Medicine

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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
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Sponsors and Collaborators
Five Prime Therapeutics, Inc.
Investigators
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Study Director: Medical Lead Five Prime Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Five Prime Therapeutics, Inc.:
Publications:
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Responsible Party: Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02318329    
Other Study ID Numbers: FPA144-001
First Posted: December 17, 2014    Key Record Dates
Results First Posted: March 11, 2020
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data will be provided to investigative sites requesting information for secondary publication.
Supporting Materials: Study Protocol
Time Frame: After publication of the primary endpoint results.
Access Criteria: Participating investigators in good standing.
Keywords provided by Five Prime Therapeutics, Inc.:
FGFR2b, FGFR2, FGFR, bladder neoplasms, esophageal cancer
Additional relevant MeSH terms:
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Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Site
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases