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.
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
Interventions
| Drug | Synonyms | Arms |
|---|
| Erdafitinib | JNJ-42756493 | Erdafitinib |
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
| Name | Type | Description | Interventions |
|---|
| Erdafitinib | Experimental | Participants 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. | |
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
advanced, unresectable, or 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 15 days or greater than or equal to (>=) 5 half-lives of the
agent (whichever is longer) and up to a maximum of 30 days before the first dose of
erdafitinib
- The presence of FGFR gatekeeper and resistance mutations
- Histologic demonstration of urothelial carcinoma
- 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: | Recruiting |
| Lead Sponsor: | Janssen Research & Development, LLC |
Last Updated
August 11, 2021
