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CompletedLast updated: 20 February 2024

RAGNAR: This phase II trial is testing an oral targeted therapy (Erdafitinib) in patients diagnosed with an advanced cancer with changes to the FGFR geneA Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations

Clinical summary

Summary

Eligible patients will receive a dose of erdafitinib oral tablets until disease progression, intolerable toxicity, withdrawal of consent, or decision by the investigator to discontinue treatment.

Conditions

This trial is treating patients with advanced cancers with a FGFR alteration.

Cancer

Multi-Cancer Multi-Cancer

Age

People12+

Phase

II

Trial Acronym

RAGNAR

More information

Trial Identifiers

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Trial sponsor

Janssen-Cilag Pty Ltd

Scientific Title

A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations

Eligibility

Inclusion

  • 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

Exclusion

  • 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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Completed hospitals

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