Clinical trial NCT01697605: A Phase I Study of Oral BGJ398 in Asian Patients
Official title: A Phase I Study of Oral BGJ398 in Asian Patients With Advanced Solid Tumor Having Alterations of the FGF-R Pathway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumor With Alterations of the FGF-R
Keywords: Phase I, open-label, dose escalation, BGJ398, Japanese, Asian, FGF-R
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-10-02
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).

Detailed description: This is a multi-center, open label, dose finding, phase I study of oral single agent BGJ398, administered on a continuous once and/or twice daily schedule.

Eligibility criteria: Inclusion Criteria:

* Patients with advanced solid tumors with FGF-R alteration
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate organ function

Exclusion Criteria:

* Patients with untreated and/or symptomatic metastatic Central Nerve System (CNS) disease
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Incidence rate and category of dose limiting toxicities (DLTs)
timeFrame: First cycle of 28 days
Secondary outcomes:
measure: Frequency of all Adverse Events (AEs) and Serious Advers Events (SAEs)
timeFrame: From within 21 days of first treatment to 28 days after treatment discontinuation
measure: Changes in hematology and chemistry values
timeFrame: From baseline to 28 days after treatment discontinuation
measure: Assessments of physical examinations, vital signs and electrocardiograms (ECGs)
timeFrame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
measure: Time vs. concentration profiles
timeFrame: 1 to 10 time points (0, 0.25, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose) up to 24 weeks
measure: Preliminary anti-tumor activity
timeFrame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
measure: Best overall response (BOR)
timeFrame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
measure: Overall response rate (ORR)
timeFrame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.
measure: Progression-free survival (PFS)
timeFrame: From date of end of treatment until the date of progression, or date of death, or starting date of a new anticancer therapy, assessed up to 100 months.
measure: Duration of all Adverse Events (AEs)
timeFrame: From within 21 days of first treatment to 28 days after treatment discontinuation
measure: Duration of Serious Advers Events (SAEs)
timeFrame: From within 21 days of first treatment to 28 days after treatment discontinuation
measure: Severity of all Adverse Events (AEs)
timeFrame: From within 21 days of first treatment to 28 days after treatment discontinuation
measure: Severity of all Serious Advers Events (SAEs)
timeFrame: From within 21 days of first treatment to 28 days after treatment discontinuation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Guangzhou
country: China
facility: Novartis Investigative Site
city: Nagoya-city
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East (NCEE)
state: Chiba
city: Kobe-shi
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Sayama
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: