Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT03104335
Status:
WITHDRAWN
Last Update Posted:
2020-05-19
First Post:
2017-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Apatinib for Advanced Soft Tissue Sarcoma Patients: a Phase 2, Multicenter Trial
Sponsor:
Peking University People's Hospital
Organization:
Study Overview
Official Title:
Apatinib for Advanced Soft Tissue Sarcoma Patients After Failure of Traditional Therapy: an One-armed, Phase 2, Open-label, Multicenter Prospective Trial
Status:
WITHDRAWN
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not enough patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with advanced soft tissue sarcoma(rhabdomyosarcoma and liposarcoma excluded), who experience progression after standard chemotherapy, have limited treatment options which promise a survival benefit.This trial tends to explore apatinib, which is a domestic highly selective inhibitor of vascular endothelial growth factor receptor-2, as a treatment option for heavily pretreated soft tissue sarcoma patients.
Detailed Description:
From April 1st 2017 to June 1st 2019, participants who met the following criteria were included: 1) histologically confirmed high-grade soft tissue sarcoma(rhabdomyosarcoma and liposarcoma excluded); 2) initial treated in the orthopedic oncology departments of three affiliated hospitals of Peking University,including Peking University People's Hospital, Peking University Shougang Hospital and Peking University International Hospital; 3) not amenable to curative treatment; 4) multiple metastatic lesions which could not be cured by local therapy or unresectable local advanced lesions; 5) having measurable lesions according to Response Evaluation Criteria for Solid Tumors 1.1(RECIST 1.1); 6) expected to live longer than 3 months with an Eastern Cooperative Oncology Group performance status of 0 or 1 and acceptable hematologic, hepatic, and renal function; 7) needed to be verified refractory to doxorubicin and ifosfamide.
All those participants need to sign informed consent forms for data collection and use for research purpose before inclusion, of which children patients' informed forms should be signed by their legal parents. Once the patient registered, he/she will be evaluated by his/her doctors of these departments at the clinic, and his/her follow-up should be done every eight weeks with at least chest CT as well as imaging of tumor lesions at other sites. A follow-up file should be sent every eight weeks to the coordination desk of these departments. This study was approved by the institutional review board, Peking University People's Hospital, Peking University Shougang Hospital and Peking University International Hospital Ethics Committee for Clinical Investigation, and conducted in accordance with the Declaration of Helsinki and Good Clinical Practice.
The investigators demand patients to use at least doxorubicin and ifosfamide. In a phase I trial, apatinib (Jiangsu Hengrui Medicine, Lianyungang, China) showed good oral bioavailability at a dose of 850 mg a day, the maximum-tolerated dose. Considering this, the participants are designed to receive 750 mg daily once oral administration of apatinib for body surface area (BSA) \> 1.5 and 500mg daily for BSA \<1.5. If the investigators meet with treatment interruptions because of grade 3 hematologic or grade 2 non-hematologic toxicities, dose reductions to 750 mg or 500 mg of apatinib per day, and supportive care should be allowed for the management of adverse events (AEs).
The primary objective is to describe the efficacy of apatinib in sarcoma patients. Endpoints is objective response rate (CR+PR) and Progression-Free-Survival (PFS) for each protocol as described containing apatinib according to RECIST 1.1. The secondary objective is overall survival (OS), duration of response (DR) and the characterization of toxicities. PFS is defined as the time from the start of using apatinib until disease progression or death, whichever occurs first. OS is defined as the time from the start of using apatinib until death. The period from appearance of response or stable disease to progression or death is thus considered the duration of response (DR).
Safety evaluation will be based on the frequency and severity of toxicities graded according to the Common Terminology Criteria for Adverse Events.
All those participants need to sign informed consent forms for data collection and use for research purpose before inclusion, of which children patients' informed forms should be signed by their legal parents. Once the patient registered, he/she will be evaluated by his/her doctors of these departments at the clinic, and his/her follow-up should be done every eight weeks with at least chest CT as well as imaging of tumor lesions at other sites. A follow-up file should be sent every eight weeks to the coordination desk of these departments. This study was approved by the institutional review board, Peking University People's Hospital, Peking University Shougang Hospital and Peking University International Hospital Ethics Committee for Clinical Investigation, and conducted in accordance with the Declaration of Helsinki and Good Clinical Practice.
The investigators demand patients to use at least doxorubicin and ifosfamide. In a phase I trial, apatinib (Jiangsu Hengrui Medicine, Lianyungang, China) showed good oral bioavailability at a dose of 850 mg a day, the maximum-tolerated dose. Considering this, the participants are designed to receive 750 mg daily once oral administration of apatinib for body surface area (BSA) \> 1.5 and 500mg daily for BSA \<1.5. If the investigators meet with treatment interruptions because of grade 3 hematologic or grade 2 non-hematologic toxicities, dose reductions to 750 mg or 500 mg of apatinib per day, and supportive care should be allowed for the management of adverse events (AEs).
The primary objective is to describe the efficacy of apatinib in sarcoma patients. Endpoints is objective response rate (CR+PR) and Progression-Free-Survival (PFS) for each protocol as described containing apatinib according to RECIST 1.1. The secondary objective is overall survival (OS), duration of response (DR) and the characterization of toxicities. PFS is defined as the time from the start of using apatinib until disease progression or death, whichever occurs first. OS is defined as the time from the start of using apatinib until death. The period from appearance of response or stable disease to progression or death is thus considered the duration of response (DR).
Safety evaluation will be based on the frequency and severity of toxicities graded according to the Common Terminology Criteria for Adverse Events.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: