Trial · NCT01027910
PCI-24781 in Combination With Doxorubicin to Treat Sarcoma
NCT01027910, Phase 1, Phase 2, Completed, Massachusetts General Hospital; results first posted 2017-02-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PCI-24781 in Combination With Doxorubicin to Treat Sarcoma. Trials, record NCT01027910. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01027910
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PCI-24781 in Combination With Doxorubicin to Treat Sarcoma
- NCT number
- NCT01027910
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Sarcoma
- Interventions
- PCI-24781, Doxorubicin, GCSF
- First posted
- 2009-12-09
- Last updated
- 2025-07-24
- Results first posted
- 2017-02-14
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose | up to 30 days after starting study drugs | |
| Secondary | Dose Limiting Toxicities | 1 year | number of patients who experienced dose limiting toxicities |
| Secondary | Number of Partial Responses (PR) | 1 year | number of patients who demonstrated partial response to therapy as determined by 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; Overall Response (OR) = CR + PR. |
| Secondary | Rate of Progression-free Survival at 6 Months in Participants Who Received PCI-24781/Doxorubicin Combination Administration. | 2 years |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose | up to 30 days after starting study drugs | The two groups differ in that GCSF was offered if clinically indicated in arm 1 while it was administered to all participants in arm 2. | mg/m2 | NUMBER |
| SECONDARY | Dose Limiting Toxicities | 1 year | participants | NUMBER | |
| SECONDARY | Number of Partial Responses (PR) | 1 year | participants | NUMBER | |
| SECONDARY | Rate of Progression-free Survival at 6 Months in Participants Who Received PCI-24781/Doxorubicin Combination Administration. | 2 years | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose | PCI-24781 + Doxorubicin Without Mandatory GCSF | 15 | mg/m2 | ||
| Maximum Tolerated Dose | PCI-24781 With Mandatory GCSF | 45 | mg/m2 | ||
| Dose Limiting Toxicities | Optional GCSF | 2 | participants | ||
| Dose Limiting Toxicities | Mandatory GCSF | 2 | participants | ||
| Number of Partial Responses (PR) | Optional GCSF | 0 | participants | ||
| Number of Partial Responses (PR) | Mandatory GCSF | 3 | participants | ||
| Rate of Progression-free Survival at 6 Months in Participants Who Received PCI-24781/Doxorubicin Combination Administration. | Optional GCSF | 1 | participants | ||
| Rate of Progression-free Survival at 6 Months in Participants Who Received PCI-24781/Doxorubicin Combination Administration. | Mandatory GCSF | 6 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PCI-24781 + Doxorubicin Without Mandatory GCSF | 6 | |
| Overall Study | STARTED | PCI-24781 + Doxorubicin With Mandatory GCSF | 14 | |
| Overall Study | COMPLETED | PCI-24781 + Doxorubicin Without Mandatory GCSF | 6 | |
| Overall Study | COMPLETED | PCI-24781 + Doxorubicin With Mandatory GCSF | 14 | |
| Overall Study | NOT COMPLETED | PCI-24781 + Doxorubicin Without Mandatory GCSF | 0 | |
| Overall Study | NOT COMPLETED | PCI-24781 + Doxorubicin With Mandatory GCSF | 0 |
Source ClinicalTrials.gov
Adverse events8
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 | diarrhea | Gastrointestinal disorders | PCI-24781+Dox Without Mandated GCSF | 1 | 6 | 1 |
| other | diarrhea | Gastrointestinal disorders | PCI-24781+Dox With Mandated GCSF | 0 | 14 | 0 |
| serious | grade 3 or 4 neutropenia | Blood and lymphatic system disorders | PCI-24781+Dox Without Mandated GCSF | 0 | 6 | 0 |
| serious | grade 3 or 4 neutropenia | Blood and lymphatic system disorders | PCI-24781+Dox With Mandated GCSF | 2 | 14 | 2 |
| serious | infection | Infections and infestations | PCI-24781+Dox Without Mandated GCSF | 1 | 6 | 1 |
| serious | infection | Infections and infestations | PCI-24781+Dox With Mandated GCSF | 0 | 14 | 0 |
| serious | thrombocytopenia | Blood and lymphatic system disorders | PCI-24781+Dox Without Mandated GCSF | 1 | 6 | 1 |
| serious | thrombocytopenia | Blood and lymphatic system disorders | PCI-24781+Dox With Mandated GCSF | 0 | 14 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PCI-24781+Dox Without Mandated GCSF | ||
| Total, all-cause mortality | PCI-24781+Dox With Mandated GCSF | ||
| Total, other adverse events | PCI-24781+Dox Without Mandated GCSF | 1 | 6 |
| Total, other adverse events | PCI-24781+Dox With Mandated GCSF | 0 | 14 |
| Total, serious adverse events | PCI-24781+Dox Without Mandated GCSF | 2 | 6 |
| Total, serious adverse events | PCI-24781+Dox With Mandated GCSF | 2 | 14 |
Source ClinicalTrials.gov
Papers7
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Optional GCSF vs Mandatory GCSF: Rate of Progression-free Survival at 6 Months in Participants Who Received PCI-24781/Doxorubicin Combination Administration. | Trial comparisons |
| Optional GCSF vs Mandatory GCSF: Number of Partial Responses (PR) | Trial comparisons |
| Optional GCSF vs Mandatory GCSF: Dose Limiting Toxicities | Trial comparisons |
| PCI-24781+Dox Without Mandated GCSF vs PCI-24781+Dox With Mandated GCSF: serious adverse events | 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/NCT01027910
GET https://conductscience.org/api/trials/v1/NCT01027910/registered