Trial · NCT01751308
Safety and Efficacy of Cabazitaxel in Pediatric Patients With Refractory Solid Tumors Including Central Nervous System Tumors
NCT01751308, Phase 1, Phase 2, Completed, Sanofi; results first posted 2016-08-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Cabazitaxel in Pediatric Patients With Refractory Solid Tumors Including Central Nervous System Tumors. Trials, record NCT01751308. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01751308
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Cabazitaxel in Pediatric Patients With Refractory Solid Tumors Including Central Nervous System Tumors
- NCT number
- NCT01751308
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Malignant Solid Tumor - Malignant Nervous System Neoplasm
- Interventions
- Cabazitaxel (XRP6258)
- First posted
- 2012-12-17
- Last updated
- 2016-08-12
- Results first posted
- 2016-08-12
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Maximum Tolerated Dose of Cabazitaxel | Cycle 1 (21 days) | MTD was highest dose level of cabazitaxel at which no more than 1 of 6 evaluable participants experienced dose limiting toxicities (DLT). DLT defined as an AE or abnormal laboratory values related to study treatment: hematologic DLTs: any Grade(G)4 hematologic toxicity except neutropenia G4 lasting≤7 days,G3 or 4 febrile neutropenia except G3 or 4 febrile neutropenia in absence of granulocyte-colony stimulating factor prophylaxis, G4 thrombocytopenia; non-hematologic DLTs:any G≥3 non-hematologic toxicity except G3 nausea or G3 or4 vomiting, G3 or4 diarrhea,G3 or4 dehydration,G3 fatigue lasting≤7 days, inadequately treated hypersensitivity reactions, elevated transaminases\<10\* upper limit of normal of ≤7 days, re-treatment delay of\>2 weeks due to delayed recovery from toxicity related to study treatment to baseline G or≤ G1(except for alopecia) and platelet transfusion during Cycle1. Grades based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. |
| Primary | Phase 2: Percentage of Participants With Objective Response (OR) | Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks) | OR in participants was defined as the participants with a Complete Response (CR) or Partial Response (PR) after 3 cycles of cabazitaxel treatment and maintained for at least 4 weeks. CR and PR were based on modified response assessment in neuro-oncology (RANO) criteria for participants with CNS tumors. CR was defined as disappearance of all target lesions. PR was defined as ≥50% decrease in the sum of the products of the two perpendicular diameters of target lesions, compared to the baseline measurement. |
| Primary | Phase 2: Duration of Response (DOR) | Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks) | DOR defined as time (in days) from date of first response until date of first documented progressive disease (PD) or death (from any cause), whichever came first. If progression or death was not observed, participant was censored at the date of participant's last progression-free tumor assessment prior to study cut-off date. PD as per RANO criteria was defined as ≥ 25% increase in the product of perpendicular diameters of any target lesion, taking as reference the smallest product observed since the start of treatment or the appearance of one or more new lesions, or worsening neurologic status not explained by causes unrelated to tumor progression (example, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc.) plus any increase in tumor cross-sectional area (or tumor volume). |
| Secondary | Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline up to DP or death due to any cause (maximum duration: 112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) | AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. Treatment emergent adverse events (TEAEs) were defined as AEs that developed or worsened in grade or became serious during the on-treatment period which was defined as the period from the time of first dose of cabazitaxel until 30 days following the last administration of cabazitaxel. |
| Secondary | Phase 1: Number of Participants With Objective Response | Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 112.1 weeks) | OR in participants was defined as the participants with a CR or PR after 3 cycles of cabazitaxel treatment and maintained for at least 4 weeks as assessed by response evaluation criteria in solid tumors (RECIST) version 1.1 and RANO criteria for CNS tumors. For solid tumors, as per RECIST 1.1, CR defined as disappearance of all target and non-target lesions (any pathological lymph nodes, must had reduction in short axis to \<10 mm); PR defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. For CNS tumors, as per RANO criteria, CR defined as disappearance of all target and non-target lesions; PR defined as a ≥50% decrease in the sum of the products of the two perpendicular diameters of target lesions, compared to baseline measurement. |
| Secondary | Phase 1 and 2: Pharmacokinetics (PK) Parameter of Cabazitaxel: Area Under the Plasma Concentration (AUC) Versus Time Curve | Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI | Blood samples for PK parameters were collected at 5 minutes before end of infusion (EOI), 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1. |
| Secondary | Phase 1 and 2: PK Parameter of Cabazitaxel: Total Plasma Clearance (CL) | Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI | Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1. |
| Secondary | Phase 1 and 2: PK Parameter of Cabazitaxel: Volume of Distribution at Steady State (Vss) | Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI | Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1. |
| Secondary | Phase 1 and 2: PK Parameter of Cabazitaxel: Maximum Plasma Concentration Observed (Cmax) | Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI | Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1. |
| Secondary | Phase 2: Progression Free Survival (PFS) | Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks) | The PFS was defined as the time (in months) from the date of first dose administration until the date of first documented PD or death (from any cause), whichever came first. If progression or death was not observed, the participant was censored at the date of the participant's last progression-free tumor assessment prior to the study cut-off date. PD as per RANO criteria was defined as ≥25% increase in the product of perpendicular diameters of any target lesion, taking as reference the smallest product observed since the start of treatment or the appearance of one or more new lesions, or worsening neurologic status not explained by causes unrelated to tumor progression (example, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc) plus any increase in tumor cross-sectional area (or tumor volume). The analysis was performed by Kaplan-Meier method. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Maximum Tolerated Dose of Cabazitaxel | Cycle 1 (21 days) | DLT evaluable population defined as a subset of participants in the Phase 1 part of the study from the AT population who received the first dose of cabazitaxel and had sufficient safety evaluations or experienced a DLT during Cycle 1. | mg/m^2 | NUMBER |
| PRIMARY | Phase 2: Percentage of Participants With Objective Response (OR) | Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks) | Efficacy evaluable population was subset of AT population with measurable disease with a baseline and at least one post-baseline tumor evaluation.Number of participants analyzed=participants with available data for this endpoint. | percentage of participants | NUMBER |
| PRIMARY | Phase 2: Duration of Response (DOR) | Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks) | Due to no objective responses in Stage 1 of Phase 2, the analysis of duration of response was not performed.Hence, the data is not reported. | ||
| SECONDARY | Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline up to DP or death due to any cause (maximum duration: 112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) | Analysis was performed on safety population (AT population). | participants | NUMBER |
| SECONDARY | Phase 1: Number of Participants With Objective Response | Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 112.1 weeks) | Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint. | participants | NUMBER |
| SECONDARY | Phase 1 and 2: Pharmacokinetics (PK) Parameter of Cabazitaxel: Area Under the Plasma Concentration (AUC) Versus Time Curve | Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI | PK population (for both Phase 1 and Phase 2 parts of the study) included all participants who received treatment on Day 1 of Cycle 1 and had at least one post-dose PK sample. Number of participants analyzed=participants with available data for this endpoint. | ng.h/mL | MEAN |
| SECONDARY | Phase 1 and 2: PK Parameter of Cabazitaxel: Total Plasma Clearance (CL) | Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI | Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint. | L/h/m^2 | MEAN |
| SECONDARY | Phase 1 and 2: PK Parameter of Cabazitaxel: Volume of Distribution at Steady State (Vss) | Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI | Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint. | L/m^2 | MEAN |
| SECONDARY | Phase 1 and 2: PK Parameter of Cabazitaxel: Maximum Plasma Concentration Observed (Cmax) | Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI | Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint. | ng/mL | MEAN |
| SECONDARY | Phase 2: Progression Free Survival (PFS) | Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks) | Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint. | months | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1: Maximum Tolerated Dose of Cabazitaxel | Phase 1: Overall Population | 30 | mg/m^2 | ||
| Phase 2: Percentage of Participants With Objective Response (OR) | Phase 2: Cabazitaxel 30 mg/m^2 | CR | 0 | percentage of participants | |
| Phase 2: Percentage of Participants With Objective Response (OR) | Phase 2: Cabazitaxel 30 mg/m^2 | PR | 0 | percentage of participants | |
| Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Phase 1: Cabazitaxel 20 mg/m^2 | 6 | participants | ||
| Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Phase 1: Cabazitaxel 25 mg/m^2 | 3 | participants | ||
| Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Phase 1: Cabazitaxel 30 mg/m^2 | 7 | participants | ||
| Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Phase 1: Cabazitaxel 35 mg/m^2 | 7 | participants | ||
| Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Phase 2: Cabazitaxel 30 mg/m^2 | 16 | participants | ||
| Phase 1: Number of Participants With Objective Response | Phase 1: Cabazitaxel 20 mg/m^2 | 1 | participants | ||
| Phase 1: Number of Participants With Objective Response | Phase 1: Cabazitaxel 25 mg/m^2 | 0 | participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 | STARTED | Phase 1: Cabazitaxel 20 mg/m^2 | 6 | |
| Phase 1 | STARTED | Phase 1: Cabazitaxel 25 mg/m^2 | 3 | |
| Phase 1 | STARTED | Phase 1: Cabazitaxel 30 mg/m^2 | 7 | |
| Phase 1 | STARTED | Phase 1: Cabazitaxel 35 mg/m^2 | 7 | |
| Phase 1 | STARTED | Phase 2: Cabazitaxel 30 mg/m^2 | 0 | |
| Phase 1 | COMPLETED | Phase 1: Cabazitaxel 20 mg/m^2 | 6 | |
| Phase 1 | COMPLETED | Phase 1: Cabazitaxel 25 mg/m^2 | 3 | |
| Phase 1 | COMPLETED | Phase 1: Cabazitaxel 30 mg/m^2 | 7 | |
| Phase 1 | COMPLETED | Phase 1: Cabazitaxel 35 mg/m^2 | 7 | |
| Phase 1 | COMPLETED | Phase 2: Cabazitaxel 30 mg/m^2 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events765
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 | Anaemia | Blood and lymphatic system disorders | Phase 1: Cabazitaxel 20 mg/m^2 | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: Cabazitaxel 25 mg/m^2 | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: Cabazitaxel 30 mg/m^2 | 2 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: Cabazitaxel 35 mg/m^2 | 1 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Cabazitaxel 30 mg/m^2 | 1 | 16 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 1: Cabazitaxel 20 mg/m^2 | 0 | 6 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 1: Cabazitaxel 25 mg/m^2 | 0 | 3 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 1: Cabazitaxel 30 mg/m^2 | 1 | 7 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 1: Cabazitaxel 35 mg/m^2 | 0 | 7 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 2: Cabazitaxel 30 mg/m^2 | 0 | 16 |
1 to 10 of 765Source ClinicalTrials.gov
See all 765 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: Cabazitaxel 20 mg/m^2 | ||
| Total, all-cause mortality | Phase 1: Cabazitaxel 25 mg/m^2 | ||
| Total, all-cause mortality | Phase 1: Cabazitaxel 30 mg/m^2 | ||
| Total, all-cause mortality | Phase 1: Cabazitaxel 35 mg/m^2 | ||
| Total, all-cause mortality | Phase 2: Cabazitaxel 30 mg/m^2 | ||
| Total, other adverse events | Phase 1: Cabazitaxel 20 mg/m^2 | 6 | 6 |
| Total, other adverse events | Phase 1: Cabazitaxel 25 mg/m^2 | 3 | 3 |
| Total, other adverse events | Phase 1: Cabazitaxel 30 mg/m^2 | 7 | 7 |
| Total, other adverse events | Phase 1: Cabazitaxel 35 mg/m^2 | 7 | 7 |
| Total, other adverse events | Phase 2: Cabazitaxel 30 mg/m^2 | 15 | 16 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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GET https://conductscience.org/api/trials/v1/NCT01751308/results?page=2