Trial · NCT01653028
Alisertib in Treating Patients With Advanced or Metastatic Sarcoma
NCT01653028, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-12-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Alisertib in Treating Patients With Advanced or Metastatic Sarcoma. Trials, record NCT01653028. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01653028
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alisertib in Treating Patients With Advanced or Metastatic Sarcoma
- NCT number
- NCT01653028
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 72 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Myxofibrosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Leiomyosarcoma, Recurrent Liposarcoma, Recurrent Malignant Peripheral Nerve Sheath Tumor, Recurrent Undifferentiated Pleomorphic Sarcoma, Stage III Soft Tissue Sarcoma AJCC v7, Stage IV Soft Tissue Sarcoma AJCC v7
- Interventions
- Alisertib, Laboratory Biomarker Analysis
- First posted
- 2012-07-30
- Last updated
- 2017-11-30
- Results first posted
- 2016-12-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart. | Up to 18 months | The primary endpoint was estimated by the number of confirmed responses divided by the total number of evaluable patients per cohort. The study used a two stage Simon design to assess the primary endpoint. A confirmed tumor response rate of 5% was considered not promising; an observed confirmed response rate of 25% was considered promising. One confirmed response within the initial 9 patients enrolled within each cohort, expanded enrollment to 24 patients in that cohort. 3 out of 24 patients with confirmed tumor responses was considered evidence that this treatment could be recommended for further testing. This study design yielded 90% power to detect a true confirmed response rate of at least 25% at .10 level of significance if the true rate is at most 5%. There was a 63% chance of stopping early if the true confirmed response rate was 5%. |
| Secondary | Overall Survival (OS) | The time between registration and death, assessed up to 18 months | The distribution will be estimated by the methods of Kaplan and Meier. The estimates of survival at specific time points will be calculated (eg, median, 6 month survival). |
| Secondary | Progression Free Survival (PFS) | The time between registration to disease progression or death, assessed up to 18 months | The distribution will be estimated by the methods of Kaplan and Meier. The estimates of PFS at specific time points will be calculated (eg, median, 1 year PFS). |
| Secondary | Adverse Events | During treatment and up to 5 years | Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below. |
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 | The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart. | Up to 18 months | percentage of patients with response | NUMBER | |
| SECONDARY | Overall Survival (OS) | The time between registration and death, assessed up to 18 months | Weeks | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) | The time between registration to disease progression or death, assessed up to 18 months | Weeks | MEDIAN | |
| SECONDARY | Adverse Events | During treatment and up to 5 years | All patients that began study treatment were assessed for this endpoint. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart. | Cohort 1 | 0 | percentage of patients with response | ||
The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart. | Cohort 2 | 0 | percentage of patients with response | ||
The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart. | Cohort 3 | 0 | percentage of patients with response | ||
The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart. | Cohort 4 | 0 | percentage of patients with response | ||
The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart. | Cohort 5 | 7 | percentage of patients with response | ||
| Overall Survival (OS) | Cohort 1 | NA | 95% Confidence Interval 23.3 to NA | Weeks | |
| Overall Survival (OS) | Cohort 2 | 71.7 | 95% Confidence Interval 16 to NA | Weeks | |
| Overall Survival (OS) | Cohort 3 | 67.8 | 95% Confidence Interval 19 to NA | Weeks | |
| Overall Survival (OS) | Cohort 4 | 69 | 95% Confidence Interval 16 to NA | Weeks | |
| Overall Survival (OS) | Cohort 5 | 28.6 | 95% Confidence Interval 16.6 to 51.3 | Weeks |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 12 | |
| Overall Study | STARTED | Cohort 2 | 10 | |
| Overall Study | STARTED | Cohort 3 | 11 | |
| Overall Study | STARTED | Cohort4 | 10 | |
| Overall Study | STARTED | Cohort 5 | 29 | |
| Overall Study | COMPLETED | Cohort 1 | 12 | |
| Overall Study | COMPLETED | Cohort 2 | 10 | |
| Overall Study | COMPLETED | Cohort 3 | 11 | |
| Overall Study | COMPLETED | Cohort4 | 10 | |
| Overall Study | COMPLETED | Cohort 5 | 29 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events755
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 | Cohort 1 | 10 | 12 | 32 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 2 | 4 | 10 | 15 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 3 | 7 | 11 | 44 |
| other | Anemia | Blood and lymphatic system disorders | Cohort4 | 6 | 10 | 15 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 5 | 15 | 29 | 37 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort 1 | 1 | 12 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort 2 | 0 | 10 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort 3 | 1 | 11 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort4 | 0 | 10 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort 5 | 2 | 29 | 2 |
1 to 10 of 755Source ClinicalTrials.gov
See all 755 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | ||
| Total, all-cause mortality | Cohort 2 | ||
| Total, all-cause mortality | Cohort 3 | ||
| Total, all-cause mortality | Cohort4 | ||
| Total, all-cause mortality | Cohort 5 | ||
| Total, other adverse events | Cohort 1 | 12 | 12 |
| Total, other adverse events | Cohort 2 | 8 | 10 |
| Total, other adverse events | Cohort 3 | 11 | 11 |
| Total, other adverse events | Cohort4 | 9 | 10 |
| Total, other adverse events | Cohort 5 | 28 | 29 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27502708 | DERIVED |
Source PubMed
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180821 | Alliance for Clinical Trials in Oncology Operations Center | Galanis, Evanthia; Hahn, Olwen; Kozono, David | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
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/NCT01653028
GET https://conductscience.org/api/trials/v1/NCT01653028/results?page=2