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A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

NCT ID: NCT01004224

Last Updated: 2019-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-11

Study Completion Date

2018-10-08

Brief Summary

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

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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BGJ398

Group Type EXPERIMENTAL

BGJ398

Intervention Type DRUG

Interventions

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BGJ398

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with histologically/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer 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 a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing.
* For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period

Exclusion Criteria

* Patients with primary CNS tumor or CNS tumor involvement
* Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
* History and/or current evidence of ectopic mineralization/ calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception 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, keratoconjunctivitis etc., confirmed by ophthalmologic examination.
* History or current evidence of cardiac arrhythmia and/or conduction abnormality
* Women who are pregnant or nursing.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Duarte, California, United States

Site Status

Novartis Investigative Site

Los Angeles, California, United States

Site Status

Novartis Investigative Site

Los Angeles, California, United States

Site Status

University of Colorado Dept. of Anschutz Cancer (3)

Aurora, Colorado, United States

Site Status

Novartis Investigative Site

New Haven, Connecticut, United States

Site Status

Novartis Investigative Site

Boston, Massachusetts, United States

Site Status

Novartis Investigative Site

Detroit, Michigan, United States

Site Status

Memorial Sloan Kettering Cancer Center Onc. Dept..

New York, New York, United States

Site Status

Novartis Investigative Site

New York, New York, United States

Site Status

Novartis Investigative Site

Columbus, Ohio, United States

Site Status

Novartis Investigative Site

Philadelphia, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital Onc Dept

Philadelphia, Pennsylvania, United States

Site Status

Novartis Investigative Site

Pittsburgh, Pennsylvania, United States

Site Status

Novartis Investigative Site

Memphis, Tennessee, United States

Site Status

Novartis Investigative Site

Nashville, Tennessee, United States

Site Status

Novartis Investigative Site

Salt Lake City, Utah, United States

Site Status

Novartis Investigative Site

Heidelberg, Victoria, Australia

Site Status

Novartis Investigative Site

Vienna, , Austria

Site Status

Novartis Investigative Site

Bordeaux, , France

Site Status

Novartis Investigative Site

Lyon, , France

Site Status

Novartis Investigative Site

Marseille, , France

Site Status

Novartis Investigative Site

Montpellier, , France

Site Status

Novartis Investigative Site

Paris, , France

Site Status

Novartis Investigative Site

Saint-Herblain Cédex, , France

Site Status

Novartis Investigative Site

Suresnes, , France

Site Status

Novartis Investigative Site

Toulouse, , France

Site Status

Novartis Investigative Site

Villejuif, , France

Site Status

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Essen, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Marburg, , Germany

Site Status

Novartis Investigative Site

Ramat Gan, , Israel

Site Status

Novartis Investigative Site

Tel Aviv, , Israel

Site Status

Novartis Investigative Site

Meldola, FC, Italy

Site Status

Novartis Investigative Site

Amsterdam, , Netherlands

Site Status

Novartis Investigative Site

Amsterdam, , Netherlands

Site Status

Novartis Investigative Site

Singapore, , Singapore

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Seville, Andalusia, Spain

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Valencia, Valencia, Spain

Site Status

Novartis Investigative Site

Barcelona, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Novartis Investigative Site

Bangkok, , Thailand

Site Status

Novartis Investigative Site

Chiang Mai, , Thailand

Site Status

Novartis Investigative Site

Izmir, , Turkey (Türkiye)

Site Status

Countries

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

Other Identifiers

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2009-010876-73

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CBGJ398X2101

Identifier Type: -

Identifier Source: org_study_id

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