Trial · NCT02517918
Metronomic Chemotherapy in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma
NCT02517918, Phase 1, Completed, Institut Bergonié; results first posted 2025-06-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Metronomic Chemotherapy in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma. Trials, record NCT02517918. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02517918
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Metronomic Chemotherapy in Patients With Advanced Solid Tumor With Bone Metastasis and Advanced Pretreated Osteosarcoma
- NCT number
- NCT02517918
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 23 participants, actual
- Lead sponsor
- Institut Bergonié
- Conditions
- Solid Tumor, Osteosarcoma
- Interventions
- Sirolimus combined with CP, MT and ZA
- First posted
- 2015-08-07
- Last updated
- 2025-06-08
- Results first posted
- 2025-06-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Escalation Part: Number of Dose-Limiting Toxicities (DLTs) at Each Dose Level on Cycle 1 | During the first cycle (28 days) | A DLT is defined as an adverse event (AE) or laboratory abnormality that fulfills the criteria below: * Is considered to be at least possibly related to the study treatment * Occurs during the first cycle of treatment * Is unrelated to disease, disease progression, inter-current illness, or concomitant medications * Meets one of the criteria below, graded as outlined or according to NCI CTCAEv4.3: * Grade 4 non-haematological toxicity (not laboratory) * Grade 3 non-haematological toxicity \> 3 days (not laboratory) (except for asthenia, 1rst episode of nausea/vomiting without maximal symptomatic/prophylactic treatment) * Grade ≥ 3 non-hematologic laboratory value if medical intervention is required to treat the patient, or the abnormality leads to hospitalization, or the abnormality persists for \> 1 week * Grade ≥ 3 hematologic toxicity \> 3 days (except for lymphopenia) * Grade 4 lymphopenia * Confirmed febrile neutropenia |
| Primary | Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, in Terms of 6-month Non-progression Rate | 6-month non-progression rate as per RECIST v1.1 | 6-month non-progression rate defined as the rate of complete or partial response or stable disease at 6 months using RECIST v1.1 : * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions and also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). * Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD * Unevaluable : patients stopped the treatment before tumor assessment. |
| Secondary | Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, Best Objective Response Rate (ORR) as Per RECIST v1.1 | Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from the start of treatment and at least 4 weeks after the first CR or PR, even if there are treatment delays, an average of 4 months. | The best objective response (BOR) is the best response recorded for each patient from the start of the study treatment until the end of treatment for progressive disease, death, patient or investigator decision. BOR is determined by investigator review of tumor assessments using RECIST v1.1 : * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions and also demonstrate an absolute increase of at least 5 mm * Stable Disease (SD) Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from start of treatment and at least 4 weeks after the first CR or PR, even if there are treatment delays, average of 4 months |
| Secondary | Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, 1-year Progression-free Survival (PFS) | 1-year Progression-free survival (PFS) as per RECIST v1.1 | 1-year Progression-free survival (PFS) is defined as the time from study treatment initiation to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment). Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). |
| Secondary | Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, 1-year Overall Survival (OS) | 1-year Overall Survival (OS) as per RECIST v1.1 | 1-year Overall Survival (OS) is defined as the time from first infusion to death (of any cause) |
| Secondary | Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, Best Objective Response Rate (ORR) as Per RECIST v1.1 | Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from the start of treatment and at least 4 weeks after the first CR or PR, even if there are treatment delays, an average of 4 months. | The best objective response (BOR) is the best response recorded for each patient from the start of the study treatment until the end of treatment for progressive disease, death, patient or investigator decision. BOR is determined by investigator review of tumor assessments using RECIST v1.1 : * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions and also demonstrate an absolute increase of at least 5 mm * Stable Disease (SD) Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from start of treatment and at least 4 weeks after the first CR or PR, even if there are treatment delays, an average of 4 months |
| Secondary | Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, 1-year Progression-free Survival (PFS) as Per RECIST v1.1 | 1-year Progression-free survival (PFS) as per RECIST v1.1 | 1-year Progression-free survival (PFS) is defined as the time from study treatment initiation to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment). Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). |
| Secondary | Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, 1-year Overall Survival (OS) as Per RECIST v1.1 | 1-year Overall Survival (OS) as per RECIST v1.1 | 1-year Overall Survival (OS) is defined as the time from first infusion to death (of any cause) |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose Escalation Part: Number of Dose-Limiting Toxicities (DLTs) at Each Dose Level on Cycle 1 | During the first cycle (28 days) | Population assessable : Patients who received at least one dose of one of the trial's products and have received the complete C1 cycle (28 days: D1 to D28) or have exhibited a DLT during C1. | Number of DLTs | NUMBER |
| PRIMARY | Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, in Terms of 6-month Non-progression Rate | 6-month non-progression rate as per RECIST v1.1 | Population assessable : Patients eligible and who received at least one complete or two incomplete treatment cycles and least one disease measurement recorded not less than eight weeks after treatment onset. | participants | NUMBER |
| SECONDARY | Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, Best Objective Response Rate (ORR) as Per RECIST v1.1 | Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from the start of treatment and at least 4 weeks after the first CR or PR, even if there are treatment delays, an average of 4 months. | Population assessable : Patients who received at least one dose of one of the trial's products and have received the complete C1 cycle (28 days: D1 to D28) or have exhibited a DLT during C1. | participants | NUMBER |
| SECONDARY | Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, 1-year Progression-free Survival (PFS) | 1-year Progression-free survival (PFS) as per RECIST v1.1 | Population assessable : Patients who received at least one dose of one of the trial's products and have received the complete C1 cycle (28 days: D1 to D28) or have exhibited a DLT during C1. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, 1-year Overall Survival (OS) | 1-year Overall Survival (OS) as per RECIST v1.1 | Population assessable : Patients who received at least one dose of one of the trial's products and have received the complete C1 cycle (28 days: D1 to D28) or have exhibited a DLT during C1. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, Best Objective Response Rate (ORR) as Per RECIST v1.1 | Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from the start of treatment and at least 4 weeks after the first CR or PR, even if there are treatment delays, an average of 4 months. | Population assessable : Patients eligible and who received at least one complete or two incomplete treatment cycles and least one disease measurement recorded not less than eight weeks after treatment onset. | participants | NUMBER |
| SECONDARY | Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, 1-year Progression-free Survival (PFS) as Per RECIST v1.1 | 1-year Progression-free survival (PFS) as per RECIST v1.1 | Population assessable : Patients eligible and who received at least one complete or two incomplete treatment cycles and least one disease measurement recorded not less than eight weeks after treatment onset. | months | MEDIAN |
| SECONDARY | Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, 1-year Overall Survival (OS) as Per RECIST v1.1 | 1-year Overall Survival (OS) as per RECIST v1.1 | Population assessable : Patients eligible and who received at least one complete or two incomplete treatment cycles and least one disease measurement recorded not less than eight weeks after treatment onset. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose Escalation Part: Number of Dose-Limiting Toxicities (DLTs) at Each Dose Level on Cycle 1 | Dose Escalation Part With Sirolimus (Si) Dose 4 mg | 0 | Number of DLTs | ||
| Dose Escalation Part: Number of Dose-Limiting Toxicities (DLTs) at Each Dose Level on Cycle 1 | Dose Escalation Part With Sirolimus (SI) Dose 6 mg | 2 | Number of DLTs | ||
| Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, in Terms of 6-month Non-progression Rate | Expansion Cohort With Dose Sirolimus (SI) 4 mg | Complete response | 0 | participants | |
| Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, in Terms of 6-month Non-progression Rate | Expansion Cohort With Dose Sirolimus (SI) 4 mg | Partial response confirmed | 1 | participants | |
| Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, in Terms of 6-month Non-progression Rate | Expansion Cohort With Dose Sirolimus (SI) 4 mg | Stable disease | 1 | participants | |
| Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, in Terms of 6-month Non-progression Rate | Expansion Cohort With Dose Sirolimus (SI) 4 mg | Progression | 10 | participants | |
| Expansion Cohort : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, in Terms of 6-month Non-progression Rate | Expansion Cohort With Dose Sirolimus (SI) 4 mg | Unevaluable according to RECIST v1.1 | 2 | participants | |
| Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, Best Objective Response Rate (ORR) as Per RECIST v1.1 | Dose Escalation Part With Sirolimus (Si) Dose 4 mg | Completed response | 0 | participants | |
| Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, Best Objective Response Rate (ORR) as Per RECIST v1.1 | Dose Escalation Part With Sirolimus (SI) Dose 6 mg | Completed response | 0 | participants | |
| Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, Best Objective Response Rate (ORR) as Per RECIST v1.1 | Dose Escalation Part With Sirolimus (Si) Dose 4 mg | Partial response | 0 | participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Escalation Part With Sirolimus (Si) Dose 4 mg | 6 | |
| Overall Study | STARTED | Dose Escalation Part With Sirolimus (SI) Dose 6 mg | 3 | |
| Overall Study | STARTED | Expansion Cohort With Dose Sirolimus (SI) 4 mg | 14 | |
| Overall Study | COMPLETED | Dose Escalation Part With Sirolimus (Si) Dose 4 mg | 6 | |
| Overall Study | COMPLETED | Dose Escalation Part With Sirolimus (SI) Dose 6 mg | 3 | |
| Overall Study | COMPLETED | Expansion Cohort With Dose Sirolimus (SI) 4 mg | 14 | |
| Overall Study | NOT COMPLETED | Dose Escalation Part With Sirolimus (Si) Dose 4 mg | 0 | |
| Overall Study | NOT COMPLETED | Dose Escalation Part With Sirolimus (SI) Dose 6 mg | 0 | |
| Overall Study | NOT COMPLETED | Expansion Cohort With Dose Sirolimus (SI) 4 mg | 0 |
Source ClinicalTrials.gov
Adverse events300
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Dose Escalation Part With Sirolimus (Si) Dose 4 mg | 1 | 6 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Dose Escalation Part With Sirolimus (SI) Dose 6 mg | 2 | 3 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Expansion Cohort With Dose Sirolimus (SI) 4 mg | 4 | 14 | 6 |
| other | Sinus tachycardia | Cardiac disorders | Dose Escalation Part With Sirolimus (Si) Dose 4 mg | 0 | 6 | 0 |
| other | Sinus tachycardia | Cardiac disorders | Dose Escalation Part With Sirolimus (SI) Dose 6 mg | 0 | 3 | 0 |
| other | Sinus tachycardia | Cardiac disorders | Expansion Cohort With Dose Sirolimus (SI) 4 mg | 1 | 14 | 1 |
| other | Glaucoma | Eye disorders | Dose Escalation Part With Sirolimus (Si) Dose 4 mg | 0 | 6 | 0 |
| other | Glaucoma | Eye disorders | Dose Escalation Part With Sirolimus (SI) Dose 6 mg | 0 | 3 | 0 |
| other | Glaucoma | Eye disorders | Expansion Cohort With Dose Sirolimus (SI) 4 mg | 1 | 14 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Escalation Part With Sirolimus (Si) Dose 4 mg | 0 | 6 | 0 |
1 to 10 of 300Source ClinicalTrials.gov
See all 300 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation Part With Sirolimus (Si) Dose 4 mg | ||
| Total, all-cause mortality | Dose Escalation Part With Sirolimus (SI) Dose 6 mg | ||
| Total, all-cause mortality | Expansion Cohort With Dose Sirolimus (SI) 4 mg | ||
| Total, other adverse events | Dose Escalation Part With Sirolimus (Si) Dose 4 mg | 6 | 6 |
| Total, other adverse events | Dose Escalation Part With Sirolimus (SI) Dose 6 mg | 3 | 3 |
| Total, other adverse events | Expansion Cohort With Dose Sirolimus (SI) 4 mg | 14 | 14 |
| Total, serious adverse events | Dose Escalation Part With Sirolimus (Si) Dose 4 mg | 3 | 6 |
| Total, serious adverse events | Dose Escalation Part With Sirolimus (SI) Dose 6 mg | 3 | 3 |
| Total, serious adverse events | Expansion Cohort With Dose Sirolimus (SI) 4 mg | 9 | 14 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31401903 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Dose Escalation Part With Sirolimus (Si) Dose 4 mg vs Dose Escalation Part With Sirolimus (SI) Dose 6 mg: Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, 1-year Progression-free Survival (PFS) | Trial comparisons |
Dose Escalation Part With Sirolimus (Si) Dose 4 mg vs Dose Escalation Part With Sirolimus (SI) Dose 6 mg: Dose Escalation Part : Antitumor Activity Observed With Sirolimus Combined With CP, MT and ZA, 1-year Overall Survival (OS) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02517918
GET https://conductscience.org/api/trials/v1/NCT02517918/results?page=2