A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

NCT01004224 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: CBGJ398X21012009-010876-73
• Study Type: interventional
• Target: 208
• Locations: 13 countries
• Sites: 49

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  23 months

Secondary Outcomes (4)

• 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)

  23 months

• To determine the pharmacokinetic (PK) profiles of oral BGJ398

  23 months

• To evaluate the pharmacodynamic effect of the drug.

  23 months

• Assess preliminary anti-tumor activity for patients not in Arm 4.

  23 months

Study Arms (1)

BGJ398

EXPERIMENTAL

Drug: BGJ398

Interventions

BGJ398 DRUG

BGJ398

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (50)

Novartis Investigative Site

Duarte, California, 91010 3000, United States

Location

Novartis Investigative Site

Los Angeles, California, 90033, United States

Location

Novartis Investigative Site

Los Angeles, California, 90095, United States

Location

University of Colorado Dept. of Anschutz Cancer (3)

Aurora, Colorado, 80045, United States

Location

Novartis Investigative Site

New Haven, Connecticut, 06520, United States

Location

Novartis Investigative Site

Boston, Massachusetts, 02114, United States

Location

Novartis Investigative Site

Detroit, Michigan, 48201, United States

Location

Memorial Sloan Kettering Cancer Center Onc. Dept..

New York, New York, 10021, United States

Location

Novartis Investigative Site

New York, New York, 10029, United States

Location

Novartis Investigative Site

Columbus, Ohio, 43221, United States

Location

Novartis Investigative Site

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital Onc Dept

Philadelphia, Pennsylvania, 19107-5098, United States

Location

Novartis Investigative Site

Pittsburgh, Pennsylvania, 15232, United States

Location

Novartis Investigative Site

Memphis, Tennessee, 38120, United States

Location

Novartis Investigative Site

Nashville, Tennessee, 37203, United States

Location

Novartis Investigative Site

Salt Lake City, Utah, 84103, United States

Location

Novartis Investigative Site

Heidelberg, Victoria, 3084, Australia

Location

Novartis Investigative Site

Vienna, A-1100, Austria

Location

Novartis Investigative Site

Bordeaux, 33075, France

Location

Novartis Investigative Site

Lyon, 69373, France

Location

Novartis Investigative Site

Marseille, 13273, France

Location

Novartis Investigative Site

Montpellier, 34298, France

Location

Novartis Investigative Site

Paris, 75015, France

Location

Novartis Investigative Site

Saint-Herblain Cédex, 44805, France

Location

Novartis Investigative Site

Suresnes, 92150, France

Location

Novartis Investigative Site

Toulouse, 31059, France

Location

Novartis Investigative Site

Villejuif, 94805, France

Location

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Marburg, 35039, Germany

Location

Novartis Investigative Site

Ramat Gan, 5265601, Israel

Location

Novartis Investigative Site

Tel Aviv, 6423906, Israel

Location

Novartis Investigative Site

Meldola, FC, 47014, Italy

Location

Novartis Investigative Site

Amsterdam, 1066 CX, Netherlands

Location

Novartis Investigative Site

Amsterdam, 1081 HV, Netherlands

Location

Novartis Investigative Site

Singapore, 169610, Singapore

Location

Novartis Investigative Site

Seoul, Korea, 05505, South Korea

Location

Novartis Investigative Site

Seoul, 03080, South Korea

Location

Novartis Investigative Site

Seville, Andalusia, 41013, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46009, Spain

Location

Novartis Investigative Site

Barcelona, 08041, Spain

Location

Novartis Investigative Site

Madrid, 28009, Spain

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Novartis Investigative Site

Madrid, 28050, Spain

Location

Novartis Investigative Site

Taipei, 10048, Taiwan

Location

Novartis Investigative Site

Bangkok, 10330, Thailand

Location

Novartis Investigative Site

Chiang Mai, 50200, Thailand

Location

Novartis Investigative Site

Izmir, 35040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Neoplasms; Urinary Bladder Neoplasms

Interventions

infigratinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2009
• First Posted: October 29, 2009
• Study Start: December 11, 2009
• Primary Completion: October 8, 2018
• Study Completion: October 8, 2018
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1); KR (2); FR (9); TH (2); IL (2); IT (1); SG (1); US (16); AU (1); DE (4); NL (2); ES (7); TW (1)