Trial · NCT00949325
Safety and Efficacy Study of Torisel and Liposomal Doxorubicin for Patients With Recurrent Sarcoma
NCT00949325, Phase 1, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2019-03-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Torisel and Liposomal Doxorubicin for Patients With Recurrent Sarcoma. Trials, record NCT00949325. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00949325
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Torisel and Liposomal Doxorubicin for Patients With Recurrent Sarcoma
- NCT number
- NCT00949325
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- Sarcoma
- Interventions
- temsirolimus plus liposomal doxorubicin
- First posted
- 2009-07-30
- Last updated
- 2019-03-11
- Results first posted
- 2019-03-11
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Incidence of Dose Limiting Toxicities | End of second 28-day cycle | Dose limiting toxicities in each dose cohort. |
| Primary | Part 2: Median Overall Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2 | up to 5 years | Number of days from day 1 of treatment until date of death from any cause. |
| Secondary | Median Progression-free Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2 | up to 3 years | Interval from Date of start of treatment to date of disease progression or death from any cause. Disease progression is defined as at least 20% increase in sum of longest diameter of target lesions or appearance of any new lesions. Subjective determination of significant worsening of disease-related symptoms was considered clinical disease progression. |
| Secondary | Objective Response Rate | up to 5 years | Number of participants who completed at least 2 treatment cycles with evidence of response. Response is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression |
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Prior to the initial dose on day 1, then 2, 6, and 24 hours post dose; prior to first dose of Cycle 2, then at 1, 2, 6, 24, 96, and 120 hours post dose in patients treated at the recommended phase 2 dose, Dose Level 4. | Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS |
| Secondary | Area Under the Curve (AUC) | Prior to the initial dose on day 1, then 2, 6, and 24 hours post dose; prior to first dose of Cycle 2, then at 1, 2, 6, 24, 96, and 120 hours post dose in patients treated at the recommended phase 2 dose, Dose Level 4. | AUC was calculated using a single compartment model. |
| Secondary | Drug Clearance | Prior to the initial dose on day 1, then 2, 6, and 24 hours post dose; prior to first dose of Cycle 2, then at 1, 2, 6, 24, 96, and 120 hours post dose in patients treated at the recommended phase 2 dose, Dose Level 4. | Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS. |
| Secondary | Mean Progression Free Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2 | up to 3 years | Interval from start of treatment to disease progression or death from any cause. Disease progression is defined as at least 20% increase in sum of longest diameter of target lesions or appearance of any new lesions. Subjective determination of significant worsening of disease-related symptoms was considered clinical disease progression |
| Secondary | Mean Overall Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2 | up to 5 years | |
| Secondary | Time to Response | up to 5 years | Number of days after 2 cycles of treatment, until maximal response is observed. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Incidence of Dose Limiting Toxicities | End of second 28-day cycle | participants | NUMBER | |
| PRIMARY | Part 2: Median Overall Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2 | up to 5 years | The number of analyzed participants does not include the 2 participants treated at the MTD who stopped treatment for early disease-related adverse events. | days | MEDIAN |
| SECONDARY | Median Progression-free Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2 | up to 3 years | The number of analyzed participants does not include the 2 participants treated at the MTD who stopped treatment for early disease-related adverse events. | days | MEDIAN |
| SECONDARY | Objective Response Rate | up to 5 years | Only participants who completed at least 2 treatment cycles (14/18 participants) were included to assess this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) | Prior to the initial dose on day 1, then 2, 6, and 24 hours post dose; prior to first dose of Cycle 2, then at 1, 2, 6, 24, 96, and 120 hours post dose in patients treated at the recommended phase 2 dose, Dose Level 4. | Seven subjects had complete series of blood samples available for evaluation for both Temsirolimus, the parent drug and Sirolimus, the active metabolite. The number (N) evaluable participants is less than the number of participants from whom samples were collected due to inadvertent processing mishaps. | mg/mL | MEAN |
| SECONDARY | Area Under the Curve (AUC) | Prior to the initial dose on day 1, then 2, 6, and 24 hours post dose; prior to first dose of Cycle 2, then at 1, 2, 6, 24, 96, and 120 hours post dose in patients treated at the recommended phase 2 dose, Dose Level 4. | Seven subjects had complete series of blood samples available for evaluation for both Temsirolimus, the parent drug and Sirolimus, the active metabolite. The analysis was per protocol. The number (N) evaluable samples is less than the number of collected samples due to inadvertent processing mishaps. | ng*hr/ml | MEAN |
| SECONDARY | Drug Clearance | Prior to the initial dose on day 1, then 2, 6, and 24 hours post dose; prior to first dose of Cycle 2, then at 1, 2, 6, 24, 96, and 120 hours post dose in patients treated at the recommended phase 2 dose, Dose Level 4. | L/hr/m2 | MEAN | |
| SECONDARY | Mean Progression Free Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2 | up to 3 years | Days | MEAN | |
| SECONDARY | Mean Overall Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2 | up to 5 years | Subjects who received Temsirolimus MTD, 20 mg/m\^2 in Phase I of the study and all subjects in the Phase II study were included from both Phase I and Phase II of the study are included. | Days | MEAN |
| SECONDARY | Time to Response | up to 5 years | Although the original protocol specified that time to maximal response would be an outcome measure that would be obtained, appropriate data were not collected, so this outcome measure cannot be evaluated or reported. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Incidence of Dose Limiting Toxicities | Number of Subjects Who Experienced Dose-Limiting Toxicities | Temsirolimus 15 mg/m^2 | 1 | participants | |
| Part 1: Incidence of Dose Limiting Toxicities | Number of Subjects Who Experienced Dose-Limiting Toxicities | Temsirolimus 20 mg/m^2 | 4 | participants | |
| Part 1: Incidence of Dose Limiting Toxicities | Number of Subjects Who Experienced Dose-Limiting Toxicities | Temsirolimus 27 mg/m^2 | 3 | participants | |
| Part 2: Median Overall Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2 | Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2 | 254 | Full Range 50 to 1532 | days | |
| Median Progression-free Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2 | Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2 | 74 | Full Range 7 to 797 | days | |
| Objective Response Rate | Temsirolimus 20 mg/m^2 and 27 mg/m^2 | CR | 0 | Participants | |
| Objective Response Rate | Temsirolimus 20 mg/m^2 and 27 mg/m^2 | PR | 1 | Participants | |
| Objective Response Rate | Temsirolimus 20 mg/m^2 and 27 mg/m^2 | SD | 8 | Participants | |
| Objective Response Rate | Temsirolimus 20 mg/m^2 and 27 mg/m^2 | PD | 5 | Participants | |
| Maximum Observed Plasma Concentration (Cmax) | Temsirolimus- Parent Drug | 346.2 | Standard Deviation 250 | mg/mL |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1, Dose Level 3 | 3 | |
| Overall Study | STARTED | Cohort 2, Dose Level 4 | 18 | |
| Overall Study | STARTED | Cohort 3, Dose Level 5 | 3 | |
| Overall Study | COMPLETED | Cohort 1, Dose Level 3 | 3 | |
| Overall Study | COMPLETED | Cohort 2, Dose Level 4 | 16 | |
| Overall Study | COMPLETED | Cohort 3, Dose Level 5 | 3 | |
| Overall Study | NOT COMPLETED | Cohort 1, Dose Level 3 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2, Dose Level 4 | 2 | |
| Overall Study | NOT COMPLETED | Cohort 3, Dose Level 5 | 0 |
Source ClinicalTrials.gov
Adverse events15
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 | Neutropenia | Blood and lymphatic system disorders | Temsirolimus Plus Liposomal Doxorubicin | 5 | 24 | 5 |
| other | anemia | Blood and lymphatic system disorders | Temsirolimus Plus Liposomal Doxorubicin | 1 | 24 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Temsirolimus Plus Liposomal Doxorubicin | 2 | 24 | 2 |
| other | Hypokalemia | Metabolism and nutrition disorders | Temsirolimus Plus Liposomal Doxorubicin | 2 | 24 | 2 |
| other | Hypocalcemia | Metabolism and nutrition disorders | Temsirolimus Plus Liposomal Doxorubicin | 1 | 24 | 1 |
| other | Elevated transaminases | Hepatobiliary disorders | Temsirolimus Plus Liposomal Doxorubicin | 2 | 24 | 2 |
| other | Hyperlipedemia | Metabolism and nutrition disorders | Temsirolimus Plus Liposomal Doxorubicin | 1 | 24 | 1 |
| other | Stomatitis | Gastrointestinal disorders | Temsirolimus Plus Liposomal Doxorubicin | 2 | 24 | 2 |
| other | Pancreatitis | Hepatobiliary disorders | Temsirolimus Plus Liposomal Doxorubicin | 1 | 24 | 1 |
| serious | Dyspnea | Respiratory, thoracic and mediastinal disorders | Temsirolimus Plus Liposomal Doxorubicin | 2 | 24 | 2 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Temsirolimus Plus Liposomal Doxorubicin | ||
| Total, other adverse events | Temsirolimus Plus Liposomal Doxorubicin | 13 | 24 |
| Total, serious adverse events | Temsirolimus Plus Liposomal Doxorubicin | 7 | 24 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00949325
GET https://conductscience.org/api/trials/v1/NCT00949325/registered