A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies
This study is currently recruiting participants.
Verified January 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
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
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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 FGFR1 Amplication, Advanced Solid Tumors With FGFR2 Amplication, Advanced Solid Tumors With FGFR3 Mutation |
Drug: BGJ398 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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:
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 83 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BGJ398 | Drug: BGJ398 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004224
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | |
| Contact: Novartis Pharmaceuticals |
Locations
| United States, California | |
| City of Hope National Medical Center COH | Withdrawn |
| Duarte, California, United States, 91010-3000 | |
| UCLA/ University of California Los Angeles Div. of Hematology/Oncology | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Kristen Bell 310-825-4493 kdbell@mednet.ucla.edu | |
| Principal Investigator: Steve Wong | |
| United States, Colorado | |
| University of Colorado Dept. of Anschutz Cancer (3) | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Stephanie Grim +1 720 848 0655 Stephanie.Grim@ucdenver.edu | |
| Principal Investigator: David Ross Camidge | |
| United States, Massachusetts | |
| Massachusetts General Hospital Mass Gen 2 | Active, not recruiting |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6) | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Karen Forman 313-576-9373 formank@karmanos.org | |
| Principal Investigator: Patricia M. LoRusso | |
| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute HIllman Cancer Center | Completed |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Tennessee | |
| The West Clinic West Clin | Recruiting |
| Memphis, Tennessee, United States, 38120 | |
| Contact: Kostadinka Atanasovska 901-683-0055 katanasovska@theacornnetwork.com | |
| Principal Investigator: Johnetta Blakely | |
| Sarah Cannon Research Institute SC | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Wiktoria Raby wiktoria.raby@scresearch.net | |
| Principal Investigator: Howard Burris | |
| Belgium | |
| Novartis Investigative Site | Withdrawn |
| Leuven, Belgium, 3000 | |
| Canada, Ontario | |
| Novartis Investigative Site | Completed |
| Toronto, Ontario, Canada, M5G 2M9 | |
| France | |
| Novartis Investigative Site | Recruiting |
| Lyon Cedex, France, 69373 | |
| Novartis Investigative Site | Recruiting |
| Saint-Herblain Cédex, France, 44805 | |
| Novartis Investigative Site | Recruiting |
| Toulouse Cedex 3, France, 31052 | |
| Novartis Investigative Site | Recruiting |
| Villejuif Cedex, France, 94805 | |
| Germany | |
| Novartis Investigative Site | Recruiting |
| Essen, Germany, 45147 | |
| Novartis Investigative Site | Recruiting |
| Köln, Germany, 50924 | |
| Netherlands | |
| Novartis Investigative Site | Recruiting |
| Amsterdam, Netherlands, 1066 CX | |
| Singapore | |
| Novartis Investigative Site | Recruiting |
| Singapore, Singapore, 169610 | |
| Spain | |
| Novartis Investigative Site | Recruiting |
| Sevilla, Andalucía, Spain, 41013 | |
| Novartis Investigative Site | Recruiting |
| Barcelona, Cataluna, Spain, 08035 | |
| Novartis Investigative Site | Recruiting |
| Madrid, Spain, 28050 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01004224 History of Changes |
| Other Study ID Numbers: | CBGJ398X2101, 2009-010876-73 |
| Study First Received: | October 27, 2009 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Food and Drug Administration The Netherlands: The Medicines Evaluation Board (MEB) Spain: Agencia Española de Medicamentos y Productos Sanitarios France: Agence française de sécurité sanitaire des produits de santé (Afssaps) Germany: Federal Institute for Drugs and Medical Devices (BfArM) Canada: Health Canada |
Keywords provided by Novartis:
|
advanced solid tumors BGJ398 FGFR kinase inhibitor advanced solid malignancies |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013