NCT04042597

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

July 31, 2019

Last Update Submit

August 1, 2019

Conditions

Effect of DrugsQuality of LifeChordomaAdvanced Cancer

Keywords

chordomaunresectableanlotinibimatinibsurvivalquality of life

Outcome Measures

Primary Outcomes (2)

  • Objective response rate, ORR

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

    6 months

  • 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

    2 years

Secondary Outcomes (1)

  • Overall Survival, OS

    5 years

Study Arms (2)

Arm A: anlotinib arm

EXPERIMENTAL

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

Drug: Anlotinib Hydrochloride

Arm B: imatinib arm

ACTIVE COMPARATOR

Imatinib was given at dose of 400 mg twice daily continuously

Drug: Anlotinib Hydrochloride

Interventions

Anlotinib HydrochlorideDRUG

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

Arm A: anlotinib armArm B: imatinib arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Chordoma

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Wei Guo, M.D. and Ph.D.

    Musculoskeletal Tumor Center of Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Xie, M.D.

CONTACT

+8613401044719xie.lu@hotmail.com

Jie Xu, M.D.

CONTACT

+8615901040835xujie_pkuph@sina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 2, 2019

Study Start

July 18, 2019

Primary Completion

October 30, 2021

Study Completion

December 31, 2021

Last Updated

August 5, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)