Comparison · NCT02601209-a9bddf6e
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)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. 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, record NCT02601209-a9bddf6e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02601209-a9bddf6e
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0179 | 0.00316 | 0.0945 | wilson | |
| Risk in group 2 | 0.0862 | 0.0374 | 0.186 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0683 | -0.17 | 0.0225 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.207 | 0.025 | 1.72 | log | |
| Odds ratio, group 1 over group 2 | 0.193 | 0.0218 | 1.7 | log | |
| Number needed to treat, for one fewer participant with the outcome on Phase II - Analysis Group 2 MLN0128 than on Phase II - Analysis Group 2 Pazopanib | 14.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Phase II - Analysis Group 2 MLN0128 | Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle. | 1 | 56 | OG000 |
| Group 2 | Phase II - Analysis Group 2 Pazopanib | Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period. | 5 | 58 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Patients Having CR, PR, or SD at 6 Months (Phase II Analysis Group 2 - Initial Treatment Period)
- Description
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.
- Time frame
- Up to 6 months
- Population
- Phase II Analysis Group 2 - Initial Treatment Period
Source ClinicalTrials.gov
Trial
- Title
- Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma
- NCT number
- NCT02601209
- Phases
- PHASE1, PHASE2
- 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
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2020-03-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02601209?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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