Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

non-interventional

Although modern radiation techniques combined with chemotherapy has greatly improved the local control and long-term survivals for patients with early-stage NKTCL, relapse and systemic dissemination are common for localized patients. Relapsed/refractory diseases together with advanced stage NKTCLs uaually progress rapidly with poor prognosis (5-year overall survival rate, 0-20%). According to published studies, some recurrent genetic alternations have been identified in NKTCL, including oncogene/tumor suppressive gene abberants, epigenetic changes, cellular signaling pathways abnormalities, cellular apoptosis related genes and so forth. However, the gene profiling techniques and materials vary in different studies, no consensus has been reached on the gene abnormalities of advanced, or relapsed/refractory NKTCL up to now. Additionally, gene sequencing using ctDNA of peripheral blood has been unexploited in NKTCL patients.

Target Gene Sequencing for Advanced Stage, Relapsed or Refractory Natural Killer/T-cell Lymphoma

Target Gene Sequencing for Advanced Stage, Relapsed/Refractory Natural Killer/T-cell Lymphoma and the Correlation Between Gene Abmormalities and Chemotherapy Efficacy

The concordance of plasma cfDNA genotyping and tumor genotyping is defined as the ratio of gene variants detected in tumor and cfDNA to variants identified in tumor

Chinese Academy of Medical Sciences

Principal Investigator

Digestive System Diseases

Stomach Neoplasms

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Futibatinib

Advanced or metastatic solid tumors harboring FGFR1-4 rearrangements

Advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification

Myeloid or lymphoid neoplasm harboring FGFR1 rearrangement

Futibatinib tablets will be dosed orally every day on a continuous 28-day cycle

The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma \[iCCA\]); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements.

Study TAS-120-202 is an open-label, multinational, 3-arm Phase 2 study evaluating the efficacy, safety, tolerability, PK, and pharmacodynamics of futibatinib in patients with FGFR aberrations. Eligible patients will be assigned to 1 of 3 treatment cohorts based on diagnosis and FGFR gene aberration status.

Patients will receive futibatinib at an oral dose of 20 mg once a day on a continuous 28-day cycle.

The study will enroll approximately:

* Cohort A: 60 patients with locally advanced, advanced, or metastatic solid tumor harboring FGFR rearrangements other than primary brain tumor or iCCA;
* Cohort B: 35 patients with locally-advanced, advanced, or metastatic gastric cancer or gastro-esophageal junction (GEJ) with FGFR2 amplification;
* Cohort C: 20 patients with myeloid or lymphoid neoplasms (MLN) with FGFR1 rearrangements

Treatment in all cohorts will continue until disease progression, unacceptable toxicity, or any other of the criteria for treatment discontinuation is met. For patients who discontinue treatment for reasons other than disease progression, tumor assessments should be continued until radiologic disease progression is documented or until initiation of subsequent new anticancer therapy (whichever occurs first).

Patients will be followed for survival every 12 weeks (±2 weeks) until survival events (deaths) have been reported for 75% of enrolled patients or the study is terminated early by the Sponsor.

Additional cohorts may be added in the future in case of new emerging efficacy data.

The study consists of independent 3 cohorts (Cohorts A, B and C) and there is no difference in the treatment regimen between the cohorts

Futibatinib in Patients With Specific FGFR Aberrations

A Phase 2 Study of Futibatinib in Patients With Specific FGFR Aberrations

ORR, defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors, RECIST version 1.1), based on independent central review of radiological images.

CR rate, defined as the proportion of patients who achieved a CR (per response criteria for MLN) based on investigators' assessment of imaging, peripheral blood, and bone marrow.

ORR, defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on investigator assessment.

DOR, defined as the time from the first documentation of response (CR or PR in Cohorts A and B; CR, PR, or CRi in Cohort C) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.

PFS, defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression, whichever occurs first.

OS, defined as the time from the date of first dose to the death date.

DCR, defined as the proportion of patients experiencing a best overall response of stable response (SD), PR, or complete response (CR) (per RECIST 1.1).

CR+CRi rate, defined as the proportion of patients who achieved a CR or CRi

Duration of CR, defined as the time from the first documentation of CR to the first documentation of recurrence or death due to any cause, whichever occurs first.

Duration of CR+CRi, defined as the time from the first documentation of CR or CRi to the first documentation of disease relapse or death due to any cause, whichever occurs first.

CCyR rate, defined as the proportion of patients who achieved a CCyR

PCyR rate, defined as the proportion of patients who achieved a PCyR

RFS, defined as the time from first documentation of CR to the date of death (any cause) or disease relapse or death due to any cause, whichever occurs first

EFS, defined as the time from first dose of study therapy to treatment failure, disease relapse after CR, or patient death due to any cause, whichever occurs first

Safety based on reported AEs will be graded according to the National Cancer Institute- Common Terminology Criteria for Adverse events (NCI-CTCAE), Version 5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Target Gene Sequencing for Advanced Stage, Relapsed or Refractory Natural Killer/T-cell Lymphoma	NCT04509804	Lymphoid Neopla...	non-interventio...	-	ChineseAMS
Target Gene Sequencing for Advanced Stage, Relapsed or Refractory Natural Killer/T-cell Lymphoma	NCT04509804	Lymphoid Neopla...	non-interventio...	-	ChineseAMS
Futibatinib in Patients With Specific FGFR Aberrations	NCT04189445	Advanced or Met... Advanced or Met... Myeloid or Lymp...	Futibatinib	18 Years -	Taiho Oncology, Inc.

Spots Global Cancer Trial Database for lymphoid neoplasm