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Completed

NCT Number: NCT01697605

A Phase I Study of Oral BGJ398 in Asian Patients

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

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Key information

Conditions

Tumor With Alterations of the FGF-R

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Guangzhou, Guangdong, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BGJ398

Drug

Primary outcomes

  1. Incidence rate and category of dose limiting toxicities (DLTs)

    Time frame: First cycle of 28 days

    Maximum tolerated dose (MTD) and/or Recommended dose (RD) of single agent oral BGJ398

Secondary outcomes

  1. Frequency of all Adverse Events (AEs) and Serious Advers Events (SAEs)

    Time frame: From within 21 days of first treatment to 28 days after treatment discontinuation

    To characterize the safety and tolerability of oral BGJ398

  2. Changes in hematology and chemistry values

    Time frame: From baseline to 28 days after treatment discontinuation

    hematology and chemistry values

  3. Assessments of physical examinations, vital signs and electrocardiograms (ECGs)

    Time frame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.

  4. Time vs. concentration profiles

    Time frame: 1 to 10 time points (0, 0.25, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose) up to 24 weeks

    To determine the pharmacokinetic (PK) profiles (Cmax, AUC, Tmax, T1/2, etc) of oral BGJ398 including known pharmacologically active metabolites

  5. Preliminary anti-tumor activity

    Time frame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.

    Assessed based on RECIST version 1.1

  6. Best overall response (BOR)

    Time frame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.

    Assessed by investigator per RECIST version 1.1. BOR is the best response recorded until disease progression.

  7. Overall response rate (ORR)

    Time frame: Participants will be followed for the duration of treatment, an expected average of 24 weeks.

    Assessed by investigator per RECIST version 1.1. ORR is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR).

  8. Progression-free survival (PFS)

    Time frame: 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.

    PFS is defined as the times from the date of first dose of BGJ398 to the date of the first documented disease progression, date of death due to any cause or until a new anticancer therapy is initiated, whichever occurs first.

  9. Duration of all Adverse Events (AEs)

    Time frame: From within 21 days of first treatment to 28 days after treatment discontinuation

    To characterize the safety and tolerability of oral BGJ398

  10. Duration of Serious Advers Events (SAEs)

    Time frame: From within 21 days of first treatment to 28 days after treatment discontinuation

    To characterize the safety and tolerability of oral BGJ398

  11. Severity of all Adverse Events (AEs)

    Time frame: From within 21 days of first treatment to 28 days after treatment discontinuation

    To characterize the safety and tolerability of oral BGJ398

  12. Severity of all Serious Advers Events (SAEs)

    Time frame: From within 21 days of first treatment to 28 days after treatment discontinuation

    To characterize the safety and tolerability of oral BGJ398

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Phase I Study of Oral BGJ398 in Asian Patients With Advanced Solid Tumor Having Alterations of the FGF-R Pathway

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2012
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.