A Phase I Study of Oral BGJ398 in Asian Patients

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01697605
• Collaborator: (none)
• Enrollment: 9
• Locations: 8
• Arm: 1
• Actual Duration (Months): 75.6
• Patients Per Site: 1.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Tumor With Alterations of the FGF-R	Drug: BGJ398	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Study of Oral BGJ398 in Asian Patients With Advanced Solid Tumor Having Alterations of the FGF-R Pathway
• Actual Study Start Date: Oct 19, 2012
• Actual Primary Completion Date: Feb 7, 2019
• Actual Study Completion Date: Feb 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BGJ398 Eligible participants received oral BGJ398 once daily or twice daily. Patients may continue treatment with BGJ398 until the patient experiences unacceptable toxicity or progressive disease.	Drug: BGJ398

Outcome Measures

Primary Outcome Measures

1. Incidence rate and category of dose limiting toxicities (DLTs) [First cycle of 28 days]

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

Secondary Outcome Measures

1. Frequency of all Adverse Events (AEs) and Serious Advers Events (SAEs) [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 [From baseline to 28 days after treatment discontinuation]

   hematology and chemistry values

3. Assessments of physical examinations, vital signs and electrocardiograms (ECGs) [Participants will be followed for the duration of treatment, an expected average of 24 weeks.]

4. Time vs. concentration profiles [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 [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) [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) [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) [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) [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) [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) [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) [From within 21 days of first treatment to 28 days after treatment discontinuation]

    To characterize the safety and tolerability of oral BGJ398

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Guangzhou	Guangdong	China	51000
2	Novartis Investigative Site	Chengdu	Sichuan	China	610041
3	Novartis Investigative Site	Guangzhou		China	510060
4	Nagoya University Hospital	Nagoya-city	Aichi	Japan	466-8560
5	National Cancer Center Hospital East (NCEE)	Kashiwa	Chiba	Japan	277-8577
6	Novartis Investigative Site	Kobe-shi	Hyogo	Japan	650-0017
7	Novartis Investigative Site	Sayama	Osaka	Japan	589 8511
8	Shizuoka Cancer Center	Sunto-gun	Shizuoka	Japan	411-8777

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Results for CBGJ398X1101 can be found on the Novartis Clinical Trials Results website

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01697605
• Other Study ID Numbers: CBGJ398X1101
• First Posted: Oct 2, 2012
• Last Update Posted: Dec 8, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Novartis Pharmaceuticals: Phase I, open-label, dose escalation, BGJ398, Japanese, Asian, FGF-R
• Additional relevant MeSH terms: Infigratinib

Study Results

No Results Posted as of Dec 8, 2020