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A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

This study is ongoing, but not recruiting participants.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01004224

First Posted: October 29, 2009

Last Update Posted: September 14, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

Purpose

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

Condition	Intervention	Phase
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	Drug: BGJ398	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer lung cancer

U.S. FDA Resources

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:

Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD) [ Time Frame: 23 months ]
Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD). This will be calculated using an established statistical model, based on incidence of adverse events and serious adverse events, physical examinations, vital signs, electrocardiograms, and laboratory parameters

Secondary Outcome Measures:

To assess preliminary anti-tumor activity of BGJ398 for patients in expansion Arm 4 (previously treated patients with advanced/metastatic UCC with FGFR3 gene alterations) [ Time Frame: 23 months ]
overall response rate (ORR), as assessed by investigator per RECIST v 1.0; overall survival (OS), duration of response (DOR) and disease control rate (DCR) will be assessed
To determine the pharmacokinetic (PK) profiles of oral BGJ398 [ Time Frame: 23 months ]
Time vs. concentration profiles, PK parameters of BGJ398 and known active metabolite(s).
To evaluate the pharmacodynamic effect of the drug. [ Time Frame: 23 months ]
Pre- vs. post treatment serial changes in FGF23 plasma levels (not done for patients enrolled to expansion Arm 4)
Assess preliminary anti-tumor activity for patients not in Arm 4. [ Time Frame: 23 months ]
Overall tumor response rate (ORR) and PFS assessed by investigator per RECIST


Enrollment:	208
Actual Study Start Date:	December 11, 2009
Estimated Study Completion Date:	December 31, 2017
Estimated Primary Completion Date:	December 31, 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BGJ398	Drug: BGJ398

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004224

Show 50 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information


Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01004224 History of Changes
Other Study ID Numbers:	CBGJ398X2101 2009-010876-73 ( EudraCT Number )
First Submitted:	October 27, 2009
First Posted:	October 29, 2009
Last Update Posted:	September 14, 2017
Last Verified:	September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):


advanced solid tumors lung cancer bladder cancer BGJ398	FGFR kinase inhibitor advanced solid malignancies

Additional relevant MeSH terms:


Neoplasms Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms	Neoplasms by Site Urinary Bladder Diseases Urologic Diseases

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