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A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

NCT01004224 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2019-10-04

No results posted yet for this study

Summary

The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.

Conditions

  • Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3
  • Squamous Lung Cancer With FGFR1 Amplification
  • Bladder Cancer With FGFR3 Mutation or Fusion
  • Advanced Solid Tumors With FGFR1 Amplication
  • Advanced Solid Tumors With FGFR2 Amplication
  • Advanced Solid Tumors With FGFR3 Mutation

Interventions

DRUG

BGJ398

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-11
Primary Completion
2018-10-08
Completion
2018-10-08
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01004224 on ClinicalTrials.gov