A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

This study is currently recruiting participants.

Verified January 2013 by Novartis

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01004224

First received: October 27, 2009

Last updated: January 31, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 27, 2009

Last Updated Date

January 31, 2013

Start Date ^ICMJE

December 2009

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine the maximum tolerated dose and thus the recommended phase II dose and schedule of single agent oral in patients with advance solid tumors [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

To determine the maximum tolerated dose and thus the recommended phase II dose and schedule of single agent oral in patients with advance solid tumors [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01004224 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To characterize the safety and tolerability of the compound at the RPTD [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]
To determine the pharmacokinetic profiles of the drug including known pharmacologically active metabolites [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]
To evaluate the pharmacodynamic effect of the drug. [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]
To assess any preliminary anti-tumor activity. [ Time Frame: 23 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To characterize the safety and tolerability of the compound at the RPTD [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
To determine the pharmacokinetic profiles of the drug including known pharmacologically active metabolites [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]
To evaluate the pharmacodynamic effect of the drug. [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]
To assess any preliminary anti-tumor activity. [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

Official Title ^ICMJE

A Phase I, Open-label, Multi-center, Dose Escalation Study of Oral BGJ398, a Pan FGF-R Kinase Inhibitor, in Adult Patients With Advanced Solid Malignancies

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Advanced Solid Tumors With FGFR1 Amplication,
Advanced Solid Tumors With FGFR2 Amplication,
Advanced Solid Tumors With FGFR3 Mutation

Intervention ^ICMJE

Drug: BGJ398

Study Arm (s)

Experimental: BGJ398

Intervention: Drug: BGJ398

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Other protocol-defined inclusion/exclusion criteria may apply

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Novartis Pharmaceuticals	1-888-669-6682
Contact: Novartis Pharmaceuticals

Location Countries ^ICMJE

United States, Belgium, Canada, France, Germany, Netherlands, Singapore, Spain

Administrative Information

NCT Number ^ICMJE

NCT01004224

Other Study ID Numbers ^ICMJE

CBGJ398X2101, 2009-010876-73

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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