A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies
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| ClinicalTrials.gov Identifier: NCT01004224 |
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Recruitment Status :
Completed
First Posted : October 29, 2009
Last Update Posted : October 4, 2019
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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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.
| Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
| Actual Enrollment : | 208 participants |
| Allocation: | Non-Randomized |
| 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 |
| Actual Study Start Date : | December 11, 2009 |
| Actual Primary Completion Date : | October 8, 2018 |
| Actual Study Completion Date : | October 8, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Bladder cancer
| Arm | Intervention/treatment |
|---|---|
| Experimental: BGJ398 |
Drug: BGJ398 |
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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
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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
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
Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01004224 |
| Other Study ID Numbers: |
CBGJ398X2101 2009-010876-73 ( EudraCT Number ) |
| First Posted: | October 29, 2009 Key Record Dates |
| Last Update Posted: | October 4, 2019 |
| Last Verified: | October 2019 |
| 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 ):
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advanced solid tumors lung cancer bladder cancer BGJ398 |
FGFR kinase inhibitor advanced solid malignancies |
Additional relevant MeSH terms:
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Neoplasms Urinary Bladder Neoplasms Neoplasms by Site Urologic Neoplasms |
Urogenital Neoplasms Urinary Bladder Diseases Urologic Diseases |