Effect of DrugsPhase 2CSSG-03NCT04042597
Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma
A Phase 2 study testing Anlotinib Hydrochloride in people with Effect of Drugs and Quality of Life, run by Peking University People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Effect of Drugs, Quality of Life, Chordoma
- What is being tested?
- Anlotinib Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2019to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Tingting Ren, Ph. D., +861380095026, tumorcenter@163.com
About this study
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
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.
- Conditions
- Effect of Drugs, Quality of Life, Chordoma, Advanced Cancer
- Being tested
- Anlotinib Hydrochloride
- Keywords
- chordoma, unresectable, anlotinib, imatinib, survival, quality of life
- Medical subject headings
- Chordoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib HydrochlorideDrug
anlotinib was given at a fixed dose of 12mg D1-14 every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Arm A: anlotinib arm | Experimental | anlotinib was given at a fixed dose of 12mg D1-14 every 21 days Receives: Drug: Anlotinib Hydrochloride |
| Arm B: imatinib arm | Active comparator | Imatinib was given at dose of 400 mg twice daily continuously Receives: Drug: Anlotinib Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate, ORR
CR+PR in the intent-to-treat population according to RECIST, version 1.1
Measured: 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
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start18 Jul 2019
- Primary completion30 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugsStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Wei Guo, M.D. and Ph.D., Principal investigator, Musculoskeletal Tumor Center of Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042597
- Sponsor's protocol ID
- PKUPH-sarcoma 05
- Acronym
- CSSG-03
- Status last verified
- Aug 2019
- First submitted
- 31 Jul 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04042597
- Acronym / sponsor ID
- CSSG-03 / PKUPH-sarcoma 05
- Conditions
- Effect of Drugs, Quality of Life, Chordoma, Advanced Cancer
- Keywords
- chordoma, unresectable, anlotinib, imatinib, survival, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- 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
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: anlotinib arm | Experimental | Drug: Anlotinib Hydrochlorideanlotinib was given at a fixed dose of 12mg D1-14 every 21 days |
| Arm B: imatinib arm | Active comparator | Drug: Anlotinib HydrochlorideImatinib was given at dose of 400 mg twice daily continuously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anlotinib Hydrochlorideanlotinib was given at a fixed dose of 12mg D1-14 every 21 days | Drug | Arm A: anlotinib arm, Arm B: imatinib arm |
Primary outcome
Objective response rate, ORR
Time frame: 6 months
CR+PR in the intent-to-treat population according to RECIST, version 1.1
Progression-free Survival, PFS
Time frame: 2 years
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
1 secondary outcome
Overall Survival, OS
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Guo, M.D. and Ph.D. principal investigator
Musculoskeletal Tumor Center of Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib Hydrochloride in people with Effect of Drugs and Quality of Life, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Xie, M.D. (+8613401044719, xie.lu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate, ORR (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.