A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

Last updated: October 2, 2019
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

1

Condition

Bladder Cancer

Urothelial Cancer

Neoplasms

Treatment

N/A

Clinical Study ID

NCT01004224
CBGJ398X2101
2009-010876-73
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with histologically/cytologically confirmed advanced solid tumors with FGFR1or FGFR2 amplification or FGFR3 mutation, for which no further effective standardanticancer treatment exists

  • Adequate bone marrow function

  • Adequate hepatic and renal function

  • Adequate cardiovascular function

  • Contraception.

  • For women: Must be surgically sterile, post-menopausal, or compliant with amedically approved contraceptive regimen during and for 3 months after thetreatment period; must have a negative serum or urine pregnancy test and must notbe nursing.

  • For men: Must be surgically sterile or compliant with a contraceptive regimenduring and for 3 months after the treatment period

Exclusion

Exclusion Criteria:

  • Patients with primary CNS tumor or CNS tumor involvement

  • Patients with history and/or current evidence of endocrine alteration ofcalcium-phosphate homeostasis

  • History and/or current evidence of ectopic mineralization/ calcification including butnot limited to the soft tissue, kidneys, intestine, myocard and lung with theexception of calcified lymphnodes and asymptomatic coronary calcification

  • Current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitisetc., confirmed by ophthalmologic examination.

  • History or current evidence of cardiac arrhythmia and/or conduction abnormality

  • Women who are pregnant or nursing. Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 208
Study Start date:
December 11, 2009
Estimated Completion Date:
October 08, 2018

Connect with a study center

  • Novartis Investigative Site

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Novartis Investigative Site

    Linz, 4010
    Austria

    Site Not Available

  • Novartis Investigative Site

    Vienna, A-1100
    Austria

    Site Not Available

  • Novartis Investigative Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Toronto,
    Canada

    Site Not Available

  • Novartis Investigative Site

    Bordeaux Cedex, 33075
    France

    Site Not Available

  • Novartis Investigative Site

    Lille Cedex, 59020
    France

    Site Not Available

  • Novartis Investigative Site

    Lyon,
    France

    Site Not Available

  • Novartis Investigative Site

    Lyon Cedex, 69373
    France

    Site Not Available

  • Novartis Investigative Site

    Marseille, 13273
    France

    Site Not Available

  • Novartis Investigative Site

    Montellier cedex 5, 34298
    France

    Site Not Available

  • Novartis Investigative Site

    Montpellier Cedex 5, 34298
    France

    Site Not Available

  • Novartis Investigative Site

    Nantes,
    France

    Site Not Available

  • Novartis Investigative Site

    Paris, 75015
    France

    Site Not Available

  • Novartis Investigative Site

    Saint-Herblain Cédex, 44805
    France

    Site Not Available

  • Novartis Investigative Site

    Suresnes, 92150
    France

    Site Not Available

  • Novartis Investigative Sie

    Toulouse,
    France

    Site Not Available

  • Novartis Investigative Site

    Toulouse Cedex 3, 31052
    France

    Site Not Available

  • Novartis Investigative Site

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Novartis Investigative Site

    Villejuif Cedex, 94805
    France

    Site Not Available

  • Novartis Investigative Site

    Koeln, Nordrhein-Westfalen 50937
    Germany

    Site Not Available

  • Novartis Investigative Site

    Cologne,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Essen, 45147
    Germany

    Site Not Available

  • Novartis Investigative Site

    Göttingen, D-37075
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hannover, 30625
    Germany

    Site Not Available

  • Novartis Investigative Site

    Köln, 50924
    Germany

    Site Not Available

  • Novartis Investigative Site

    Marburg, 35039
    Germany

    Site Not Available

  • Novartis Investigative Site

    Haifa, 31096
    Israel

    Site Not Available

  • Novartis Investigative Site

    Petach Tikva, 49100
    Israel

    Site Not Available

  • Novartis Investigative Site

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • Novartis Investigative Site

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Novartis Investigative Site

    Tel-Aviv, 64239
    Israel

    Site Not Available

  • Novartis Investigative Site

    Ancona, AN 60126
    Italy

    Site Not Available

  • Novartis Investigative Site

    Meldola, FC 47014
    Italy

    Site Not Available

  • Novartis Investigative Site

    Milano, MI 20133
    Italy

    Site Not Available

  • Novartis Investigative Site

    Terni, TR 05100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Seoul, Korea 05505
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Singapore, 169610
    Singapore

    Site Not Available

  • Novartis Investigative Site

    Sevilla, Andalucia 41013
    Spain

    Site Not Available

  • Novartis Investigative Site

    Valencia, Comunidad Valenciana 46009
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barcelona, 08041
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28041
    Spain

    Site Not Available

  • Novartis Investigative Site

    Taipei, 10048
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Bangkok, 10330
    Thailand

    Site Not Available

  • Novartis Investigative Site

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Novartis Investigative Site

    Izmir, 35040
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Duarte, California 91010 3000
    United States

    Site Not Available

  • University of California San Diego - Moores Cancer Center Onc Dept

    La Jolla, California 92093-0658
    United States

    Site Not Available

  • Novartis Investigative Site

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of Colorado Dept. of Anschutz Cancer (3)

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Novartis Investigative Site

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • H. Lee Moffitt Cancer Center & Research Institute Dept of Onc

    Tampa, Florida 33612
    United States

    Site Not Available

  • Crescent City Research Consortium, LLC Onc Dept

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Novartis Investigative Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Novartis Investigative Site

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Montefiore Medical Center OncDept

    Bronx, New York 10467
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center Onc. Dept..

    New York, New York 10021
    United States

    Site Not Available

  • Novartis Investigative Site

    New York, New York 10029
    United States

    Site Not Available

  • Novartis Investigative Site

    Columbus, Ohio 43221
    United States

    Site Not Available

  • Novartis Investigative Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Thomas Jefferson University Hospital Onc Dept

    Philadelphia, Pennsylvania 19107-5098
    United States

    Site Not Available

  • University of Pennsylvania Medical Center Onc Dept

    Philadephia, Pennsylvania 19104
    United States

    Site Not Available

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Medical University of South Carolina Oncology Dept

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Novartis Investigative Site

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Novartis Investigative Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(8)

    Houston, Texas 77030-4009
    United States

    Site Not Available

  • Novartis Investigative Site

    Salt Lake City, Utah 84103
    United States

    Site Not Available

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