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Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma (CSSG-03)

Primary Purpose

Effect of Drugs, Quality of Life, Chordoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Anlotinib Hydrochloride

About this trial

This is an interventional treatment trial for Effect of Drugs focused on measuring chordoma, unresectable, anlotinib, imatinib, survival, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years and older;
histologically proven metastatic or locally advanced chordoma, reviewed by the Pathology Committee of Peking University People's Hospital;
not amenable to curative-intent surgery;
measurable with computed tomography scan or magnetic resonance imaging, per RECIST, version 1.1.

Exclusion Criteria:

Eastern Cooperative Oncology Group (ECOG)30 performance status more than 2 ;
life expectancy less than 12 weeks;
with severe or uncontrolled medical disorders (≥grade 2 of Common Terminology Criteria for Adverse Events version 4.03 [CTCAE version 4.03]) that could jeopardise the outcomes of the study, for example, cardiac clinical symptom or disease with LVEF (left ventricular ejection fraction) <50%, hypertension that could not be well controlled through antihypertensive drugs and so on;
weight loss of 20% or more before illness;
brain or leptomeningeal metastasis;
surgical procedure or radiotherapy within 4 weeks of enrollment;
active gastroduodenal ulcer, previous condition associated with risk of bleeding or requiring anticoagulation;
proteinuria or hematuria;
denutrition with albuminemia less than 25 g/L;
pregnant or breastfeeding status;
other malignancy, positive HBV/HCV/HIV serology;
known allergy to the experimental agents;
had ever used anti-angiogenesis TKIs.

Sites / Locations

Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: anlotinib arm

Arm B: imatinib arm

Arm Description

anlotinib was given at a fixed dose of 12mg D1-14 every 21 days

Imatinib was given at dose of 400 mg twice daily continuously

Outcomes

Primary Outcome Measures

Objective response rate, ORR

CR+PR in the intent-to-treat population according to RECIST, version 1.1

Progression-free Survival, PFS

Progression-free survival is defined as time from randomisation to the first occurrence of progression of disease or death from any cause within 63 days of last response assessment or randomisation

Secondary Outcome Measures

Overall Survival, OS

OS is defined as time from randomisation to the first occurrence of death from any cause within 63 days of last response assessment or randomisation.

Full Information

NCT ID

NCT04042597

First Posted

July 31, 2019

Last Updated

August 1, 2019

Sponsor

Peking University People's Hospital

Collaborators

Peking University Shougang Hospital, Peking University Third Hospital, Peking University First Hospital, Beijing Jishuitan Hospital, Chinese PLA General Hospital, Peking University Cancer Hospital & Institute, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04042597

Brief Title

Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma

Acronym

CSSG-03

Official Title

A Prospective, Multicentre, Open-label, Randomised Phase 2 Trial to Study the Efficacy and Safety of Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 18, 2019 (Actual)

Primary Completion Date

October 30, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking University People's Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

For local relapse not amenable to reasonable curative surgery or for those with metastatic chordoma, chemotherapy is recognised as inactive. The major study drug is the small molecular tyrosine kinase inhibitors targeted at the stem cell factor receptor (KIT) and the platelet-derived growth factor receptors (PDGFRA and PDGFRB), eg. imatinib. Anlotinib is a novel tyrosine kinase inhibitor targeting both at VEGFR-2, -3 and PDGFRA and PDGFRB with high affinity, which also showed broad antitumor activity against EGFR and so on. Thus this multicenter, two-armed phase II trial of PKUPH-sarcoma 05 intended to investigate the efficacy and safety of anlotinib versus imatinib on advanced chordoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Effect of Drugs, Quality of Life, Chordoma, Advanced Cancer

Keywords

chordoma, unresectable, anlotinib, imatinib, survival, quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A: anlotinib arm

Arm Type

Experimental

Arm Description

anlotinib was given at a fixed dose of 12mg D1-14 every 21 days

Arm Title

Arm B: imatinib arm

Arm Type

Active Comparator

Arm Description

Imatinib was given at dose of 400 mg twice daily continuously

Intervention Type

Drug

Intervention Name(s)

Anlotinib Hydrochloride

Intervention Description

anlotinib was given at a fixed dose of 12mg D1-14 every 21 days

Primary Outcome Measure Information:

Title

Objective response rate, ORR

Description

CR+PR in the intent-to-treat population according to RECIST, version 1.1

Time Frame

6 months

Title

Progression-free Survival, PFS

Description

Progression-free survival is defined as time from randomisation to the first occurrence of progression of disease or death from any cause within 63 days of last response assessment or randomisation

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall Survival, OS

Description

OS is defined as time from randomisation to the first occurrence of death from any cause within 63 days of last response assessment or randomisation.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years and older; histologically proven metastatic or locally advanced chordoma, reviewed by the Pathology Committee of Peking University People's Hospital; not amenable to curative-intent surgery; measurable with computed tomography scan or magnetic resonance imaging, per RECIST, version 1.1. Exclusion Criteria: Eastern Cooperative Oncology Group (ECOG)30 performance status more than 2 ; life expectancy less than 12 weeks; with severe or uncontrolled medical disorders (≥grade 2 of Common Terminology Criteria for Adverse Events version 4.03 [CTCAE version 4.03]) that could jeopardise the outcomes of the study, for example, cardiac clinical symptom or disease with LVEF (left ventricular ejection fraction) <50%, hypertension that could not be well controlled through antihypertensive drugs and so on; weight loss of 20% or more before illness; brain or leptomeningeal metastasis; surgical procedure or radiotherapy within 4 weeks of enrollment; active gastroduodenal ulcer, previous condition associated with risk of bleeding or requiring anticoagulation; proteinuria or hematuria; denutrition with albuminemia less than 25 g/L; pregnant or breastfeeding status; other malignancy, positive HBV/HCV/HIV serology; known allergy to the experimental agents; had ever used anti-angiogenesis TKIs.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lu Xie, M.D.

Phone

+8613401044719

xie.lu@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jie Xu, M.D.

Phone

+8615901040835

xujie_pkuph@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Guo, M.D. and Ph.D.

Organizational Affiliation

Musculoskeletal Tumor Center of Peking University People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University People's Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100044

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tingting Ren, Ph. D.

Phone

+861380095026

tumorcenter@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma

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