OsteosarcomaPhase 2GEIS-29NCT02429973
Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma
A Phase 2 study testing Gemcitabine plus rapamycin in people with Osteosarcoma, run by Broto, Javier Martín, M.D..
Trial summary
Multicenter and prospective phase II trial with gemcitabine and rapamycin in second line of metastatic osteosarcoma. The study includes 6 cycles of the combination gemcitabine+rapamycin in metastatic or unresectable osteosarcoma patients. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Gemcitabine plus rapamycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Apr 2015
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed consent signed before any trial test
- Age equal or less than 80 years
- Histological diagnosis of high-grade, metastatic or unresectable osteosarcoma in progression
- Previous treatment with drugs used in first line: methotrexate, adriamycin, platinum
- Measurable disease, acoording to RECIST criteria
- ECOG 0-2
Who cannot join
- Patients who have been irradiated on target lesions
- ECOG >2
- Bilirubin levels over normal values. Creatinine over 1.6 mg/dL
- History of other cancers except basal cell cancer or cervical cancer adequately treated
- Serious cardiovascular disease
About this study
Official title: Multicenter and Prospective Phase II Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma
Multicenter and prospective phase II trial with gemcitabine and rapamycin in second line of metastatic osteosarcoma. The study includes 6 cycles of the combination gemcitabine+rapamycin in metastatic or unresectable osteosarcoma patients.
Read the detailed description
The trial seeks to analyze progression free survival (PFS), measured as PFS rate at 4 months, in patients with metastatic osteosarcoma who have previously received the most active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide). The treatment schedule consists of a maximum of 6 cycles of 3 weeks of gemcitabine+rapamycin. Gemcitabine is given at 800 mg/m2 in days 1 and 8 in cycles of 21 days. Rapamycin is given at 5 mg per day during treatment duration.
- Conditions
- Osteosarcoma
- Being tested
- Gemcitabine plus rapamycin
- Keywords
- Osteosarcoma
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine plus rapamycinDrug
Gemcitabine and rapamycin given in combination
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 6 cycles of gemcitabine plus rapamycin Receives: Drug: Gemcitabine plus rapamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) rate
Measured: 4 months
Secondary outcomes (1)
Tumor response according to RECIST
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Broto, Javier Martín, M.D.
- Responsible party
- Sponsor
- Investigators
- Javier Martin, PhD, Principal investigator, Virgen del Rocío Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429973
- Sponsor's protocol ID
- EC11-444 OSTEOSARC
- Acronym
- GEIS-29
- Status last verified
- Apr 2015
- First submitted
- 24 Apr 2015
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter and Prospective Phase II Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma
- ClinicalTrials.gov ID
- NCT02429973
- Acronym / sponsor ID
- GEIS-29 / EC11-444 OSTEOSARC
- Conditions
- Osteosarcoma
- Keywords
- Osteosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Broto, Javier Martín, M.D.
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 29 Apr 2015 (estimated)
- 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.
Multicenter and prospective phase II trial with gemcitabine and rapamycin in second line of metastatic osteosarcoma. The study includes 6 cycles of the combination gemcitabine+rapamycin in metastatic or unresectable osteosarcoma patients.
Detailed description
The trial seeks to analyze progression free survival (PFS), measured as PFS rate at 4 months, in patients with metastatic osteosarcoma who have previously received the most active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide). The treatment schedule consists of a maximum of 6 cycles of 3 weeks of gemcitabine+rapamycin. Gemcitabine is given at 800 mg/m2 in days 1 and 8 in cycles of 21 days. Rapamycin is given at 5 mg per day during treatment duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Gemcitabine plus rapamycin6 cycles of gemcitabine plus rapamycin |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent signed before any trial test
- Age equal or less than 80 years
- Histological diagnosis of high-grade, metastatic or unresectable osteosarcoma in progression
- Previous treatment with drugs used in first line: methotrexate, adriamycin, platinum
- Measurable disease, acoording to RECIST criteria
Key exclusion criteria (5 listed)
- Patients who have been irradiated on target lesions
- ECOG >2
- Bilirubin levels over normal values. Creatinine over 1.6 mg/dL
- History of other cancers except basal cell cancer or cervical cancer adequately treated
- Serious cardiovascular disease
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 |
|---|---|---|
| Gemcitabine plus rapamycinGemcitabine and rapamycin given in combination | Drug | Experimental |
Primary outcome
Progression free survival (PFS) rate
Time frame: 4 months
1 secondary outcome
Tumor response according to RECIST
Time frame: 6 months
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 29 Apr 2015.
Related trials for Osteosarcoma
RecruitingPhase 1/2
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma
RecruitingObservational study
Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions
Pheochromocytoma, Paraganglioma
RecruitingPhase 2
Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
Osteogenic Sarcoma Recurrent
RecruitingPhase 2
The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
Osteosarcoma in Children, Osteosarcoma in Adolescents and Young Adults
RecruitingPhase 2
Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma
Pediatric Osteosarcoma
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.
Javier Martin, PhD principal investigator
Virgen del Rocío Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine plus rapamycin in people with Osteosarcoma, run by Broto, Javier Martín, M.D..
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 5 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 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 (PFS) rate (time frame: 4 months). 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 29 Apr 2015.