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Infigratinib

To estimate anti-tumor efficacy of BGJ398

BGJ398

Novartis Pharmaceuticals

This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to adult patients with histologically confirmed GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.

Patients were enrolled in two groups. Group 1 enrolled patients who are not candidates for surgery. Group 2 was planned to enroll patients who are surgical candidates. Patients from both groups were evaluated for tumor response and progression by MRI every 8 weeks until disease progression or discontinuation from study using RANO criteria.

A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

A Phase 2, Multicenter, Open-label Study of BGJ398 in Patients With Recurrent Resectable or Unresectable Glioblastoma

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

To assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes that harbor FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3 based on PFS6 (PFS rate at 6 months as defined by RANO criteria as assessed by the investigator)

To further assess the anti-tumor activity of BGJ398 for patients with GBM with an amplification, translocation, or activating mutation in FGFR1,2,3 or 4, based on Objective Response Rate (ORR - patients with measurable disease - as defined by RANO criteria as assessed by the investigator

To further assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes that harbor FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 and 3 based on Overall Survival

Safety: type, frequency, and severity of AEs and SAEs; Tolerability: dose interruptions, reductions and dose intensity, and evaluations of laboratory values

Non Surg BGJ398 125 mg

BGJ398X

Age, Continuous

Sex: Female, Male

caucasian

Race/Ethnicity, Customized

BGJ398 was out licensed and the indication was no longer pursued. Remaining patient continued treatment in post-trial settings.

Study Director

Progression Free Survival

partial response

stable disease

progressive disease

unknown

missing

Overall Response Rate

Overall Survival

participants with dose interruptions

participants with dose reductions

Safety and Tolerability

Overall Study

For patients with relapsed GBM, before receiving electric field treatment, the patient can be re-operated, and TTFields+BPC chemotherapy is used after surgery

TTFields

Qunying Yang

Yonggao Mu, chief

Yonggao Mu, Chief

Yonggao Mu

the study is a prospective, single-arm, open-label trial, designed to explore the efficacy and safety of Tumor-Treating Fields (TTFields) combined with second-line chemotherapy treatment in recurrent glioblastoma multiforme (GBM) , TTFields is an portable, battery operated device for chronic treatment of patients with recurrent or progressive glioblastoma multiforme (GBM) using alternating electric fields

PAST CLINICAL EXPERIENCE:

The effect of the electric fields generated by the TTFields has been tested in two Ⅲ phase trials in humans(EF-11\&EF-14). The data from these trials suggest TTFields may improve time to disease progression and overall survival of recurrent GBM patients. EF-11 is a randomized, controlled trial, designed to test the efficacy and safety of a new medical device.Although the number of patients in the trials is small, FDA has approved TTFields as a therapy for patients with recurrent GBM.

DESCRIPTION OF THE TRIAL:

Patients with GBM whose disease has recurred or progressed despite standard treatment (Surgery, radiation therapy, Temozolomide treatment) and meet all of the requirements for participation in the study will be included.Before receiving TTFields treatment, the patient can receive surgery again, and TTFields+BPC chemotherapy can be used after surgery; TTFields+BPC chemotherapy can also be used directly without surgery.

During the trial, TTFields treatment is a cycle (treatment course) every four weeks, and patients are required to complete at least one cycle of treatment. Recommended average daily wearing time ≥18 hours, patients will need to return once every month the hospital outpatient clinics where they will be examined by a physician and undergo routine laboratory examinations. These routine visits will continue for as long as the patient's disease is not progressing. After progression, if such occurs, patients will need to return once per month for two more months to the outpatient clinic for similar follow up examinations.

During the visits to the clinic patients will be examined physically and neurologically. A routine MRI of the head will be performed at baseline and after 2, 4 and 6 months. After this follow up plan, patients will be contacted once per month by telephone to answer basic questions about their health status. If the disease progresses, imaging tumor assessment or survival follow-up will be performed every 2 months thereafter, until 12 months of follow-up.

The investigator will use the RANO evaluation criteria for tumor imaging assessment, and classify the objective tumor response as follows: The objective tumor response status based on the evaluation of the target lesion can be: complete response (CR), partial response (PR), stable disease ( SD), disease progression (PD).

SCIENTIFIC BACKGROUND:

Electric fields exert forces on electric charges similar to the way a magnet exerts forces on metallic particles within a magnetic field. These forces cause movement and rotation of electrically charged biological building blocks, much like the alignment of metallic particles seen along the lines of force radiating outwards from a magnet.

Electric fields can also cause muscles to twitch and if strong enough may heat tissues. TTFields are alternating electric fields of low intensity. This means that they change their direction repetitively many times a second. Since they change direction very rapidly (200 thousand times a second), they do not cause muscles to twitch, nor do they have any effects on other electrically activated tissues in the body (brain, nerves and heart). Since the intensities of TTFields in the body are very low, they do not cause heating.

The breakthrough finding made by NovoCure was that finely tuned alternating fields of very low intensity, now termed TTFields (Tumor Treating Fields), cause a significant slowing in the growth of cancer cells. Due to the unique geometric shape of cancer cells when they are multiplying, TTFields cause the building blocks of these cells to move and pile up in such a way that the cells physically explode. In addition, cancer cells also contain miniature building blocks which act as tiny motors in moving essential parts of the cells from place to place. TTFields cause these tiny motors to fall apart since they have a special type of electric charge.

A Prospective, Open-label, Single-arm Clinical Study

A Prospective, Open-label, Single-arm Clinical Study Evaluating Tumor Treating Fields (TTFields) in Combination With Chemotherapy for Recurrent Glioblastom

To evaluate the OS12 of patients with recurrent glioblastoma treated with TTFields combined with chemotherapy

To evaluate the OS of patients with recurrent glioblastoma treated with tumor electric field therapy combined with chemotherapy

To evaluate the PFS of patients with recurrent glioblastoma treated with tumor electric field therapy combined with chemotherapy according to RANO standard

Adverse events and severe adverse events occurred during treatment were recorded by CTCAE V5.0, and the safety of tumor electric field therapy combined with chemotherapy was analyzed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 2 Study of BGJ398 in Patients With Recurrent GBM	NCT01975701	Recurrent Gliob...	BGJ398	18 Years -	Novartis
A Prospective, Open-label, Single-arm Clinical Study	NCT04689087	Recurrent Gliob...	TTFields	18 Years -	Sun Yat-sen University
A Prospective, Open-label, Single-arm Clinical Study	NCT04689087	Recurrent Gliob...	TTFields	18 Years -	Sun Yat-sen University
A Phase 2 Study of BGJ398 in Patients With Recurrent GBM	NCT01975701	Recurrent Gliob...	BGJ398	18 Years -	Novartis

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