Effect of DrugPhase 2OAIENCT05277480
Apatinib With Ifosfamide Plus Etoposide for Relapsed or Refractory Osteosarcoma (OAIE)
A Phase 2 study testing Apatinib+IE and IE in people with Effect of Drug and Drug, run by Peking University People's Hospital at 5 sites in China.
Trial summary
Apatinib has led to positive responses in the treatment of osteosarcoma refractory to first-line chemotherapy. However, apatinib demonstrates only short-lived activity, and the disease control of musculoskeletal lesions is worse than that of pulmonary lesions. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Effect of Drug, Drug, Toxicity
- What is being tested?
- Apatinib+IE and IE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 5 sitesChina
- Study dates
- 1 Mar 2022to 26 Nov 2023
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- advanced recurrent and refractory osteosarcoma confirmed by histopathology;
- initial treatment in the Orthopedic/Oncology Departments of Peking University People's Hospital or Peking University Shougang Hospital;
- progression less than 6 months after first-line chemotherapy with a combination of high-dose methotrexate, doxorubicin, cisplatin and ifosfamide (first-line chemotherapy);
- measurable lesions according to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1) ;
- Eastern Cooperative Oncology Group performance status ≤ 1 ;
- acceptable haematologic, hepatic, and renal function.
Who cannot join
- those who had been previously treated with antiangiogenic TKIs and single IE chemotherapy;
- those who had severe or uncontrolled medical disorders that could jeopardize the outcomes of the study. These confounding conditions included, cardiac clinical symptoms or disease with left ventricular ejection fraction<50%, and hypertension that could not be well controlled with antihypertensive drugs.;
- all patients were assessed by the sarcoma board including a thoracic surgeon with at least 10 years surgical experience. Patients with lung metastases only were carefully assessed for eligibility for metastasectomy, of whom those who were suitable for surgery were excluded from this study;
- 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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- activegastroduodenal ulcer, previous condition associated with risk of bleeding or requiring anticoagulation;
- proteinuria or hematuria, denutrition with albuminemia <25 g/L;
- women who were pregnant or breast feeding, other malignancy;
- positive HBV/HCV/HIV serology, and known allergy to the experimental agents.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Peking University People's Hospital
Beijing, Beijing Municipality
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu
Shanghai General Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality
About this study
Official title: Apatinib in Combination With Ifosfamide and Etoposide (IE) for Relapsed or Refractory Osteosarcoma Progressed Upon First-line Chemotherapy (AIEO): a Prospective, Multiple-centre, Two-arm, Phase 2 Trial
Apatinib has led to positive responses in the treatment of osteosarcoma refractory to first-line chemotherapy. However, apatinib demonstrates only short-lived activity, and the disease control of musculoskeletal lesions is worse than that of pulmonary lesions. This treatment failure has been partly overcome by the addition of ifosfamide and etoposide (IE). We have ever retrospectively compared the activity of apatinib + IE in relapsed or refractory osteosarcoma in two sarcoma centers in China and concluded that for osteosarcoma with multiple sites of metastasis, apatinib + IE demonstrated clinically meaningful antitumor activity and delayed disease progression in patients with recurrent or refractory osteosarcoma after failure of chemotherapy. However to overcome the influence of other interventions on the outcome, we are currently performing a prospective trial to investigate this combination, from which more accurate data on this treatment strategy are expected.
- Conditions
- Effect of Drug, Drug, Toxicity
- Being tested
- Apatinib+IE, IE
- Keywords
- Osteosarcoma, Apatinib, Ifosfamide, Etoposide
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib+IEDrug
apatinib po； ifosfamide ivgtt ; etoposide ivgtt .
IEDrug
ifosfamide ivgtt ; etoposide ivgtt .
| Study group | Role | What they receive |
|---|---|---|
| Apatinib+IE group | Experimental | IE: Ifosfamide Plus Etoposide Receives: Drug: Apatinib+IE |
| IE group | Active comparator | IE: Ifosfamide Plus Etoposide Receives: Drug: IE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
from the start of target treatment until disease progression or death, whichever came first.
Measured: 2 years
Secondary outcomes (1)
Overall survival
from the date of treatment initiation to death from any cause.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Mar 2022
- Primary completion30 Jun 2023
- Study completion26 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Xie Lu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277480
- Sponsor's protocol ID
- PKUPH-sarcoma 11
- Acronym
- OAIE
- Status last verified
- Jul 2024
- First submitted
- 3 Mar 2022
- Last updated
- 31 Jul 2024
- 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 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apatinib in Combination With Ifosfamide and Etoposide (IE) for Relapsed or Refractory Osteosarcoma Progressed Upon First-line Chemotherapy (AIEO): a Prospective, Multiple-centre, Two-arm, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT05277480
- Acronym / sponsor ID
- OAIE / PKUPH-sarcoma 11
- Conditions
- Effect of Drug, Drug, Toxicity
- Keywords
- Osteosarcoma, Apatinib, Ifosfamide, Etoposide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 26 Nov 2023 (actual)
- First posted
- 14 Mar 2022 (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.
Apatinib has led to positive responses in the treatment of osteosarcoma refractory to first-line chemotherapy. However, apatinib demonstrates only short-lived activity, and the disease control of musculoskeletal lesions is worse than that of pulmonary lesions. This treatment failure has been partly overcome by the addition of ifosfamide and etoposide (IE). We have ever retrospectively compared the activity of apatinib + IE in relapsed or refractory osteosarcoma in two sarcoma centers in China and concluded that for osteosarcoma with multiple sites of metastasis, apatinib + IE demonstrated clinically meaningful antitumor activity and delayed disease progression in patients with recurrent or refractory osteosarcoma after failure of chemotherapy. However to overcome the influence of other interventions on the outcome, we are currently performing a prospective trial to investigate this combination, from which more accurate data on this treatment strategy are expected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib+IE group | Experimental | Drug: Apatinib+IEIE: Ifosfamide Plus Etoposide |
| IE group | Active comparator | Drug: IEIE: Ifosfamide Plus Etoposide |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- advanced recurrent and refractory osteosarcoma confirmed by histopathology;
- initial treatment in the Orthopedic/Oncology Departments of Peking University People's Hospital or Peking University Shougang Hospital;
- progression less than 6 months after first-line chemotherapy with a combination of high-dose methotrexate, doxorubicin, cisplatin and ifosfamide (first-line chemotherapy);
- measurable lesions according to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1) ;
- Eastern Cooperative Oncology Group performance status ≤ 1 ;
Key exclusion criteria (10 listed)
- those who had been previously treated with antiangiogenic TKIs and single IE chemotherapy;
- those who had severe or uncontrolled medical disorders that could jeopardize the outcomes of the study. These confounding conditions included, cardiac clinical symptoms or disease with left ventricular ejection fraction<50%, and hypertension that could not be well controlled with antihypertensive drugs.;
- all patients were assessed by the sarcoma board including a thoracic surgeon with at least 10 years surgical experience. Patients with lung metastases only were carefully assessed for eligibility for metastasectomy, of whom those who were suitable for surgery were excluded from this study;
- 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 |
|---|---|---|
| Apatinib+IEapatinib po； ifosfamide ivgtt ; etoposide ivgtt . | Drug | Apatinib+IE group |
| IEifosfamide ivgtt ; etoposide ivgtt . | Drug | IE group |
Primary outcome
Progression free survival
Time frame: 2 years
from the start of target treatment until disease progression or death, whichever came first.
1 secondary outcome
Overall survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib+IE and IE in people with Effect of Drug and Drug, run by Peking University People's Hospital at 5 sites 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 2 years). 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 31 Jul 2024.