A Study of DCC-3014 to Evaluate the Efficacy, Safety, and Pharmacokinetics in Subjects With TGCT

Phase 2Not Yet RecruitingNCT07832747

Ono Pharmaceutical Co., Ltd.18 enrolled

Overview

To evaluate the efficacy, safety, and pharmacokinetics of DCC-3014 in subjects with Tenosynovial Giant Cell Tumor

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tenosynovial Giant Cell Tumor

Interventions

DCC-3014DRUG

DCC-3014 will be orally administered at a dose of 30 mg twice weekly.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed diagnosis of TGCT (tumor biopsy to confirm diagnosis will be required if no histology/pathology is available at screening), and a TGCT in a single joint that can be assessed for range of motion (ROM) * TGCT for which surgical resection will potentially cause worsening functional limitation or severe morbidity * Participants who have symptoms defined as at least moderate pain or at least moderate stiffness during the screening period * Other protocol defined inclusion criteria may apply Exclusion Criteria: * Metastatic TGCT or other active malignancy that requires treatment, or history of malignancy within 5 years prior to initiation of the screening period (excluding non-metastatic squamous cell carcinoma, basal cell carcinoma, or cervix carcinoma in situ with documented cure) * QT interval corrected by Fridericia's formula (QTcF) \>450 ms in males or \>470 ms in females, or history of long QT syndrome * Active liver or biliary disease, including nonalcoholic steatohepatitis (NASH) or cirrhosis * Other protocol defined exclusion criteria may apply

Locations (1)

Cancer Institute Hospital of JFCR

Tokyo, Koto, Japan

Outcomes

Primary Outcomes

ORR at Week 24

Proportion of participants with a response of CR or PR based on independent radiological review, per RECIST v1.1

Time frame: at Week 24

Secondary Outcomes

Adverse events

To assess the safety of DCC-3014 in Japanese patients with TGCT

Time frame: through study completion, an average of 3 year

ORR per TVS (Tumor Volume Score) at Week 24

Tumor response will be assessed by an independent radiological reviewer per TVS.

Time frame: at Week 24

Change from Baseline in Range of Motion (ROM) at Week 24

Active and passive ROM of the affected and non-affected joints will be assessed

Time frame: at Week 24

Change from baseline in PROMIS Physical Function score at Week 24

PROMIS(Patient-reported Outcomes Measurement Information System) Physical Function Score

Time frame: at Week 24

Change from baseline in the Worst Stiffness NRS score at Week 24

NRS（Numeric rating scale） ranges from 0 to10, 0 is equivalent to no Stiffness and 10 indicates the worst possible Stiffness.

Time frame: at Week 24

Change from baseline in EQ-VAS (self-rated health scale) at Week 24

The EQ-VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. EQ-VAS ranges from 0 to 100. Higher scores indicate better perceived health.

Central Contacts

North America Clinical Trial Support Desk

CONTACT

+18665877745 (Toll-Free)clinical_trial@ono-pharma.com

International Clinical Trial Support Desk

CONTACT

+17162141777 (Standard)clinical_trial@ono-pharma.com

Data from ClinicalTrials.gov

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