A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations (RAGNAR)
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|ClinicalTrials.gov Identifier: NCT04083976|
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : May 31, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: Erdafitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||336 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations|
|Actual Study Start Date :||November 20, 2019|
|Estimated Primary Completion Date :||December 30, 2027|
|Estimated Study Completion Date :||December 4, 2028|
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, decision by the investigator to discontinue treatment, or end of data collection timepoint if there is clinical benefit in the opinion of the investigator, has been achieved.
Participants will receive erdafitinib oral tablets.
Other Name: JNJ-42756493
- Overall Response Rate (ORR) as Assessed by Independent Review Committee (IRC) [ Time Frame: Up to 6 years and 9 months ]ORR as assessed by IRC is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR).
- Overall Response Rate as Assessed by Investigator [ Time Frame: Up to 6 years and 9 months ]ORR as assessed by investigator is defined as the percentage of participants who achieve a CR or PR.
- Duration of Response (DOR) [ Time Frame: Up to 6 years and 9 months ]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.
- Disease Control Rate (DCR) [ Time Frame: Up to 6 years and 9 months ]DCR is defined as the percentage of participants with CR, PR or stable disease (SD).
- Clinical Benefit Rate (CBR) [ Time Frame: Up to 6 years and 9 months ]CBR is defined as the percentage of participants with CR, PR or durable SD.
- Progression Free Survival (PFS) [ Time Frame: Up to 6 years and 9 months ]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.
- Overall Survival (OS) [ Time Frame: Up to 6 years and 9 months ]OS will be measured from the date of first dose of study drug to the date of the participant's death.
- Plasma Concentrations of Erdafitinib [ Time Frame: Predose and 2-4 hours postdose ]Plasma concentrations of erdafitinib will be reported.
- Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 6 years and 9 months ]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.
- Number of Participants with Adverse Events by Severity [ Time Frame: Up to 6 years and 9 months ]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.
- 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 2 years and 9 months ]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.
- 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 2 years and 9 months ]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?
- Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Change (PGIC) Scale [ Time Frame: Baseline; up to 2 years and 9 months ]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.
- 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 2 years and 9 months ]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).
- Change from Baseline in Pediatric Functional Assessment of Cancer Therapy - Brain (Peds FACT-Br) Total Score [ Time Frame: Baseline; up to 2 years and 9 months ]Peds FACT-Br consists of 4 sets of disease-specific questions pertaining to brain neoplasms (a set of 34 to 37 questions each for child, parent of child, adolescent or parent of adolescent). Peds FACT-Br total score for child ranges from 0-136 and for parent of child, adolescent and parent of adolescent the score ranges from 0-148. Here '0' indicates a severely "symptomatic participant" and highest score indicates "asymptomatic participant".
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||6 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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; or is a child or adolescent participant with a newly-diagnosed solid tumor and no acceptable standard therapies
- Documented progression of disease, defined as any progression that requires a change in treatment, prior to full study screening
- Has had prior chemotherapy, targeted therapy, or treatment with an investigational anticancer agent within 15 days or less 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, BRAF V600E and KRAS
- Active malignancies other than for disease requiring therapy
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): NCT04083976
|Contact: Study Contact||844-434-4210||Participate-In-This-Study@its.jnj.com|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|
|Responsible Party:||Janssen Research & Development, LLC|
|Other Study ID Numbers:||
2019-002113-19 ( EudraCT Number )
42756493CAN2002 ( Other Identifier: Janssen Research & Development, LLC )
|First Posted:||September 10, 2019 Key Record Dates|
|Last Update Posted:||May 31, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|