Trial · NCT02601209
Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma
NCT02601209, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2020-03-03
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma. Trials, record NCT02601209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02601209
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma
- NCT number
- NCT02601209
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 151 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
High Grade Sarcoma, Metastatic Leiomyosarcoma, Metastatic Malignant Peripheral Nerve Sheath Tumor, Metastatic Synovial Sarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma, Metastatic Unresectable Sarcoma, Myxofibrosarcoma, Recurrent Leiomyosarcoma, Recurrent Malignant Peripheral Nerve Sheath Tumor, Recurrent Synovial Sarcoma, Recurrent Undifferentiated Pleomorphic Sarcoma, Stage III Uterine Corpus Leiomyosarcoma AJCC v8, Stage IIIA Uterine Corpus Leiomyosarcoma AJCC v8, Stage IIIB Uterine Corpus Leiomyosarcoma AJCC v8, Stage IIIC Uterine Corpus Leiomyosarcoma AJCC v8, Stage IV Uterine Corpus Leiomyosarcoma AJCC v8, Stage IVA Uterine Corpus Leiomyosarcoma AJCC v8, Stage IVB Uterine Corpus Leiomyosarcoma AJCC v8, Unresectable Leiomyosarcoma
- Interventions
- Pazopanib, Pazopanib Hydrochloride, Sapanisertib
- First posted
- 2015-11-10
- Last updated
- 2022-08-23
- Results first posted
- 2020-03-03
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) | 28 days | The Maximum Tolerated Dose (MTD) of sapanisertib (MLN0128) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. The number of patients reporting a dose-limiting event is reported. |
| Primary | Progression-free Survival (PFS) (Phase II Analysis Group 2 - Initial Treatment Period) | Up to 2 years | Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and an upper confidence boundary from a 1-sided, 85% confidence interval are estimated using the Kaplan-Meier methods. |
| Secondary | The Number of Patients Who Experienced Grade 3+ Adverse Events (Phase II Analysis Group 2 - Initial Treatment Period) | Up to 4 months | The number of patients who experienced grade 3+ adverse events for Phase II Analysis Group 2 for the initial treatment period is reported below. |
| Secondary | Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD], and Progressive Disease [PD])(Phase II Analysis Group 2 - Initial Treatment Period) | Up to 2 years | The frequencies (and percentages) of tumor response categories (CR, PR, SD, PD) will be summarized for Phase II Analysis Group 2. Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to \< 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion, b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. symptomatic deterioration. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD. |
| Secondary | Duration of Response (Phase II Analysis Group 2 - Initial Treatment Period) | Time between each patient's best tumor response and progression(or date of last disease assessment for patients who die without progression or are lost to follow-up), assessed up to 2 years | Duration of response is defined as the time between each patient's best tumor response and progression (or date of last disease assessment for patients who die without progression or are lost to follow-up). Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to \< 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD. |
| Secondary | Number of Patients Having CR, PR, or SD at 6 Months (Phase II Analysis Group 2 - Initial Treatment Period) | Up to 6 months | Will be defined as the number of patients having either complete response (CR), partial response (PR), or stable disease for at least 6 months after starting treatment. The frequencies and rates of tumor response categories (CR, PR, SD, PD, and too early/not evaluated) will be summarized by dose cohort and treatment arm. Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to \< 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion,b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. symptomatic deterioration. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD. |
| Secondary | Time to Progression (TTP) (Phase II Analysis Group 2 - Initial Treatment Period) | Time between randomization and disease progression, assessed up to 2 years | Time to progression is defined as the time between randomization and disease progression. Kaplan-Meier methodology will be used to estimate the distribution of TTP. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion,b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. Symptomatic deterioration. |
| Secondary | Overall Survival (OS) (Phase II Analysis Group 2 - Initial Treatment Period) | Time between randomization and death due to any cause (or last contact for surviving patients and those lost to follow-up), assessed up to 2 years | Overall survival (OS) (Phase II Analysis Group 2 - Initial Treatment Period). Kaplan-Meier methodology will be used to estimate the distribution of OS. |
| Other | Progression-free Survival (PFS) (Phase II) | Up to 2 years | Defined as either disease progression or death (in cases where patients have died without evidence of disease progression) in crossover patients. |
| Other | Duration of Response in Crossover Patients (Phase II) | Time between each patient's best tumor response and progression>>> (or date of last disease assessment for patients who die without progression or are lost to follow-up), assessed up to 2 years | Will be analyzed using Kaplan-Meier methodology. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) | 28 days | Phase I | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Progression-free Survival (PFS) (Phase II Analysis Group 2 - Initial Treatment Period) | Up to 2 years | Phase II Analysis Group 2 - Initial Treatment Period | months | MEDIAN |
| SECONDARY | The Number of Patients Who Experienced Grade 3+ Adverse Events (Phase II Analysis Group 2 - Initial Treatment Period) | Up to 4 months | Phase II Analysis Group 2 - Initial Treatment Period; This analysis excludes cancel patients (who never received treatment i.e. Withdrew before initiation of regimen ) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD], and Progressive Disease [PD])(Phase II Analysis Group 2 - Initial Treatment Period) | Up to 2 years | Phase II Analysis Group 2 - Initial Treatment Period; Patients with tumor response data available are included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (Phase II Analysis Group 2 - Initial Treatment Period) | Time between each patient's best tumor response and progression(or date of last disease assessment for patients who die without progression or are lost to follow-up), assessed up to 2 years | Phase II Analysis Group 2 - Initial Treatment Period; Only patients that had a complete response or partial response are included in this analysis. | months | MEDIAN |
| SECONDARY | Number of Patients Having CR, PR, or SD at 6 Months (Phase II Analysis Group 2 - Initial Treatment Period) | Up to 6 months | Phase II Analysis Group 2 - Initial Treatment Period | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Progression (TTP) (Phase II Analysis Group 2 - Initial Treatment Period) | Time between randomization and disease progression, assessed up to 2 years | Phase II Analysis Group 2 - Initial Treatment Period | months | MEDIAN |
| SECONDARY | Overall Survival (OS) (Phase II Analysis Group 2 - Initial Treatment Period) | Time between randomization and death due to any cause (or last contact for surviving patients and those lost to follow-up), assessed up to 2 years | Phase II Analysis Group 2 - Initial Treatment Period | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Progression-free Survival (PFS) (Phase II) | Up to 2 years | |||
| OTHER_PRE_SPECIFIED | Duration of Response in Crossover Patients (Phase II) | Time between each patient's best tumor response and progression>>> (or date of last disease assessment for patients who die without progression or are lost to follow-up), assessed up to 2 years |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) | Phase I - Dose Level 0 | 0 | Participants | ||
| Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) | Phase I - Dose Level 1 | 0 | Participants | ||
| Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) | Phase I - Dose Level 2 | 0 | Participants | ||
| Progression-free Survival (PFS) (Phase II Analysis Group 2 - Initial Treatment Period) | Phase II - Analysis Group 2 MLN0128 | 2.0 | 95% Confidence Interval 1.9 to 3.0 | months | |
| Progression-free Survival (PFS) (Phase II Analysis Group 2 - Initial Treatment Period) | Phase II - Analysis Group 2 Pazopanib | 2.1 | 95% Confidence Interval 1.9 to 3.7 | months | |
| The Number of Patients Who Experienced Grade 3+ Adverse Events (Phase II Analysis Group 2 - Initial Treatment Period) | Phase II - Analysis Group 2 MLN0128 | 28 | Participants | ||
| The Number of Patients Who Experienced Grade 3+ Adverse Events (Phase II Analysis Group 2 - Initial Treatment Period) | Phase II - Analysis Group 2 Pazopanib | 38 | Participants | ||
| Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD], and Progressive Disease [PD])(Phase II Analysis Group 2 - Initial Treatment Period) | Phase II - Analysis Group 2 MLN0128 | Complete Response | 0 | Participants | |
| Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD], and Progressive Disease [PD])(Phase II Analysis Group 2 - Initial Treatment Period) | Phase II - Analysis Group 2 Pazopanib | Complete Response | 0 | Participants | |
| Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD], and Progressive Disease [PD])(Phase II Analysis Group 2 - Initial Treatment Period) | Phase II - Analysis Group 2 MLN0128 | Partial Response | 2 | Participants |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Treatment (Up to 4 Months) | STARTED | Phase I - Dose Level 0 | 4 | |
| Initial Treatment (Up to 4 Months) | STARTED | Phase I - Dose Level 1 | 4 | |
| Initial Treatment (Up to 4 Months) | STARTED | Phase I - Dose Level 2 | 4 | |
| Initial Treatment (Up to 4 Months) | STARTED | Phase II - Analysis Group 1 Pazopanib | 6 | |
| Initial Treatment (Up to 4 Months) | STARTED | Phase II - Analysis Group 1 MLN0128 | 13 | |
| Initial Treatment (Up to 4 Months) | STARTED | Phase II - Analysis Group 2 Pazopanib | 15 | |
| Initial Treatment (Up to 4 Months) | STARTED | Phase II - Analysis Group 2 MLN0128 | 56 | |
| Initial Treatment (Up to 4 Months) | STARTED | Phase II - Analysis Group 1 Pazopanib Crossover | 6 | |
| Initial Treatment (Up to 4 Months) | STARTED | Phase II - Analysis Group 2 Pazopanib Crossover | 43 | |
| Initial Treatment (Up to 4 Months) | COMPLETED | Phase I - Dose Level 0 | 3 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events1,715
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 | Phase I - Dose Level 0 | 0 | 3 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Phase I - Dose Level 1 | 0 | 3 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Phase I - Dose Level 2 | 1 | 3 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Phase II - Analysis Group 1 MLN0128 | 6 | 12 | 15 |
| other | Anemia | Blood and lymphatic system disorders | Phase II - Analysis Group 1 Pazopanib | 1 | 12 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Phase II - Analysis Group 2 MLN0128 | 11 | 55 | 21 |
| other | Anemia | Blood and lymphatic system disorders | Phase II - Analysis Group 2 Pazopanib | 16 | 56 | 27 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Phase I - Dose Level 0 | 0 | 3 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Phase I - Dose Level 1 | 0 | 3 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Phase I - Dose Level 2 | 0 | 3 | 0 |
1 to 10 of 1,715Source ClinicalTrials.gov
See all 1,715 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I - Dose Level 0 | 2 | 3 |
| Total, all-cause mortality | Phase I - Dose Level 1 | 1 | 3 |
| Total, all-cause mortality | Phase I - Dose Level 2 | 3 | 3 |
| Total, all-cause mortality | Phase II - Analysis Group 1 MLN0128 | 9 | 12 |
| Total, all-cause mortality | Phase II - Analysis Group 1 Pazopanib | 5 | 12 |
| Total, all-cause mortality | Phase II - Analysis Group 2 MLN0128 | 27 | 55 |
| Total, all-cause mortality | Phase II - Analysis Group 2 Pazopanib | 24 | 56 |
| Total, other adverse events | Phase I - Dose Level 0 | 3 | 3 |
| Total, other adverse events | Phase I - Dose Level 1 | 3 | 3 |
| Total, other adverse events | Phase I - Dose Level 2 | 3 | 3 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| U10CA180821 | Alliance for Clinical Trials in Oncology Operations Center | Galanis, Evanthia; Hahn, Olwen; Kozono, David | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phase II - Analysis Group 2 MLN0128 vs Phase II - Analysis Group 2 Pazopanib: Number of Patients Having CR, PR, or SD at 6 Months (Phase II Analysis Group 2 - Initial Treatment Period) | Trial comparisons |
| Phase II - Analysis Group 2 MLN0128 vs Phase II - Analysis Group 2 Pazopanib: The Number of Patients Who Experienced Grade 3+ Adverse Events (Phase II Analysis Group 2 - Initial Treatment Period) | 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/NCT02601209
GET https://conductscience.org/api/trials/v1/NCT02601209/results?page=2