A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2016 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01004224
First received: October 27, 2009
Last updated: September 19, 2016
Last verified: September 2016
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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 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: 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 study drug in patients with advance solid tumors [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]
- 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 further assess any preliminary anti-tumor activity. [ Time Frame: 23 months ] [ Designated as safety issue: No ]
- To assess preliminary anti-tumor activity of the compound in patients with advanced/metastatic urothelial cell carcinoma with FGFR3 genetic alterations [ Time Frame: 23 months ] [ Designated as safety issue: No ]
- To assess any preliminary anti-tumor activity. [ Time Frame: 23 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 190 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | April 2017 |
| Estimated Primary Completion Date: | April 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BGJ398 | Drug: BGJ398 |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004224
Show 63 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004224
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | ||
| Contact: Novartis Pharmaceuticals | +41613241111 |
Show 63 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 |
| Study First Received: | October 27, 2009 |
| Last Updated: | September 19, 2016 |
| 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 lung cancer bladder cancer BGJ398 |
FGFR kinase inhibitor advanced solid malignancies |
Additional relevant MeSH terms:
|
Neoplasms Lung Neoplasms Urinary Bladder Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Lung Diseases Respiratory Tract Diseases Urologic Neoplasms Urogenital Neoplasms Urinary Bladder Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on September 26, 2016