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A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations

NCT04083976

Description:

The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) mutations and gene fusions.

Related Conditions:
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
  • Official Title: A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations

Clinical Trial IDs

  • ORG STUDY ID: CR108661
  • SECONDARY ID: 2019-002113-19
  • SECONDARY ID: 42756493CAN2002
  • NCT ID: NCT04083976

Conditions

  • Advanced Solid Tumor

Interventions

DrugSynonymsArms
ErdafitinibJNJ-42756493Erdafitinib

Purpose

The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) mutations and gene fusions.

Detailed Description

      Erdafitinib is a selective and potent pan FGFR 1-4 inhibitor with demonstrated clinical
      activity in participants with metastatic urothelial cancer and cholangiocarcinoma identified
      to have alterations in the FGFR pathway. This study targets the underlying altered biology of
      FGFR-driven tumors irrespective of solid tumor histology subtype. The study consists of
      screening phase, treatment phase and the post treatment follow-up phase (from the end of
      treatment visit until the participants has died, withdraws consent, is lost to follow-up, or
      the end of study, whichever comes first). End of study is defined as 4 years from enrollment
      of last participant into study or last follow-up visit of last patient, whichever occurs
      first.
    

Trial Arms

NameTypeDescriptionInterventions
ErdafitinibExperimentalParticipants with fibroblast growth factor receptor (FGFR) mutations and FGFR gene fusions will receive a dose of erdafitinib oral tablets until disease progression, intolerable toxicity, withdrawal of consent, or decision by the investigator to discontinue treatment.
  • Erdafitinib

Eligibility Criteria

        Inclusion Criteria:

          -  Histologic demonstration of an unresectable, locally advanced, or metastatic solid
             tumor malignancy with an fibroblast growth factor receptor (FGFR) mutation or FGFR
             gene fusion

          -  Measurable disease

          -  Participant must have received at least one prior line of systemic therapy in the
             metastatic setting

          -  Documented progression of disease, defined as any progression that requires a change
             in treatment, prior to full study screening

        Exclusion Criteria:

          -  Has had prior chemotherapy, targeted therapy, or treatment with an investigational
             anticancer agent within 30 days or less than or equal to (<=) 5 half-lives of the
             agent (whichever is longer) before the first dose of erdafitinib

          -  The presence of FGFR gatekeeper and resistance mutations

          -  Histologic demonstration of transitional cell carcinoma of the urothelium (that is
             [i.e.], bladder cancer)

          -  Hematologic malignancy (i.e., myeloid and lymphoid neoplasms

          -  For non-small cell lung cancer participants only: pathogenic somatic mutations or gene
             fusions in the following genes: EGFR, ALK, ROS1, NTRK, and BRAF V600E

          -  Active malignancies other than for disease requiring therapy
      
Maximum Eligible Age:N/A
Minimum Eligible Age:12 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate (ORR) as Assessed by Independent Review Committee (IRC)
Time Frame:Up to 6 Years
Safety Issue:
Description:ORR as assessed by IRC is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR).

Secondary Outcome Measures

Measure:Overall Response Rate as Assessed by Investigator
Time Frame:Up to 6 Years
Safety Issue:
Description:ORR as assessed by investigator is defined as the percentage of participants who achieve a CR or PR.
Measure:Duration of Response (DOR)
Time Frame:Up to 6 Years
Safety Issue:
Description:DOR is the duration from the date of initial documentation of a response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study), or death, whichever comes first.
Measure:Disease Control Rate (DCR)
Time Frame:Up to 6 Years
Safety Issue:
Description:DCR is defined as the percentage of participants with CR, PR or stable disease (SD).
Measure:Progression Free Survival (PFS)
Time Frame:Up to 6 Years
Safety Issue:
Description:PFS is the duration from the date of the first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first.
Measure:Overall Survival (OS)
Time Frame:Up to 6 Years
Safety Issue:
Description:OS will be measured from the date of first dose of study drug to the date of the participant's death.
Measure:Plasma Concentrations of Erdafitinib
Time Frame:Predose and 2-4 hours postdose
Safety Issue:
Description:Plasma concentrations of erdafitinib will be reported.
Measure:Number of Participants with Adverse Events (AEs)
Time Frame:Up to 6 Years
Safety Issue:
Description:An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the relevant investigational product.
Measure:Number of Participants with Adverse Events by Severity
Time Frame:Up to 6 Years
Safety Issue:
Description:An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Adverse event severity is a clinical determination of the intensity of an adverse event.
Measure:Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
Time Frame:Baseline up to 6 Years
Safety Issue:
Description:The EORTC QLQ-C30 includes 30 items in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single symptom items. The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
Measure:Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
Time Frame:Baseline up to 6 Years
Safety Issue:
Description:The PGIS is a single question regarding the patient report of disease severity: considering all aspects of your cancer symptoms right now would you say your cancer symptoms are none, mild, moderate, severe, or very severe?
Measure:Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Change (PGIC) Scale
Time Frame:Baseline up to 6 Years
Safety Issue:
Description:The PGIC is the patient-reported outcome (PRO) counterpart to the clinical global impressions (CGI) scale. The PGIC is a single verbal rating scale ranging from 1 = a lot better now to 7 = a lot worse now.
Measure:Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score
Time Frame:Baseline up to 6 Years
Safety Issue:
Description:The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Janssen Research & Development, LLC

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