Trial · NCT02713386
Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT02713386, Phase 1, Phase 2, Completed, NRG Oncology; results first posted 2024-10-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Trials, record NCT02713386. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02713386
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- NCT number
- NCT02713386
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 147 participants, actual
- Lead sponsor
- NRG Oncology
- Conditions
Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, FIGO Stage III Ovarian Cancer 2014, FIGO Stage IIIA Ovarian Cancer 2014, FIGO Stage IIIA1 Ovarian Cancer, FIGO Stage IIIA2 Ovarian Cancer, FIGO Stage IIIB Ovarian Cancer 2014, FIGO Stage IIIC Ovarian Cancer 2014, FIGO Stage IVA Ovarian Cancer 2014, FIGO Stage IVB Ovarian Cancer 2014, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Primary Peritoneal Endometrioid Adenocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma, Stage III Fallopian Tube Cancer AJCC v7, Stage III Primary Peritoneal Cancer AJCC v7, Stage IIIA Fallopian Tube Cancer AJCC v7, Stage IIIA Primary Peritoneal Cancer AJCC v7, Stage IIIB Fallopian Tube Cancer AJCC v7, Stage IIIB Primary Peritoneal Cancer AJCC v7, Stage IIIC Fallopian Tube Cancer AJCC v7, Stage IIIC Primary Peritoneal Cancer AJCC v7, Stage IV Fallopian Tube Cancer AJCC v6 and v7, Stage IV Primary Peritoneal Cancer AJCC v7
- Interventions
- Carboplatin, Paclitaxel, Ruxolitinib Phosphate, Therapeutic Conventional Surgery
- First posted
- 2016-03-18
- Last updated
- 2025-05-25
- Results first posted
- 2024-10-24
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-limiting Toxicities (Phase I) | 42 days (2 cycles) | Will be assessed according to Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (CTCAE version 5.0 will be used starting 04/01/2018), or delays in treatment caused by toxicities. A DLT is defined as either hematologic or non-hematologic toxicity (assessed in accordance with the CTEP CTCAE Version 4.0), which cause any of the following (any toxicity): a dose delay \> 7 days related to any toxicity, an omission of day 8 or day 15 paclitaxel, any treatment related death. For hematologic toxicity: study treatment-related febrile neutropenia, grade 4 neutropenia lasting \> 7 days, study treatment-related grade 4 thrombocytopenia or bleeding associated with grade 3 thrombocytopenia. For non-hematologic toxicity: study treatment related grade 3 or grade 4 non-hematologic toxicity. |
| Primary | Progression-free Survival (PFS) (Phase II) | The maximum follow-up time for PFS is 57 months. | Will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. A log-rank test utilizing the categorized values of the exploratory laboratory parameters or a Cox proportional hazards (PH) model to estimate of the hazard ratio for progression or death in PFS. If feasible, the PH model will examine the effect of continuous measures. All patients must have measurable disease, and at least one "target lesion" to be used to assess response as defined by RECIST 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \>= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray. Lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI |
| Secondary | Number of Participants With Grade 3 or Higher AE (Phase I and II) | Serious and other adverse events were collected from baseline until 30 days after last treatment, an average of 10 months. | Will be assessed according to CTEP CTCAE version 4.03 (CTCAE version 5.0 will be used starting 04/01/2018). Count of Participants with grade 3 or higher AE. The participants included are the patients in Arm I and the patients in Arm II (DL1 and phase 2). The patients in phase 1 DL2 are not included because they are at a different dose level. The first 17 patients were entered between 11/14/2016 and 10/19/2017. These are the phase 1 patients. Group in DL1 entered 7 patients between 11/14/2016 - 2/17/2017. The DL2 patients were entered between 4/21/2017 and 10/19/2017. There were 10 entered in DL2 because we had a few (3 patients) who were not evaluable and needed to be replaced. From 6/28/2018 to 2/3/2020, we entered the phase 2 patients (42 vs. 88). The first 7 patients were combined with the active therapy on phase 2, for the toxicity comparison (42 vs. 88+7=95 patients). |
| Secondary | Frequency of Patients Who Could Not Receive Surgery Within the Defined Timeframe for Reasons Other Than Non-response, Disease Progression, or Medical Contraindications (Phase I) | Up to 6 weeks | Frequencies will be given by the dose-level administered. |
| Secondary | Number of Patients Who Discontinue Ruxolitinib in the First 3 Months of Maintenance Therapy Due to Toxicity (Phase I) | Up to 3 months in the maintenance phase | Number of patients who discontinue ruxolitinib in the first 3 months of maintenance therapy due to toxicity (Phase I) |
| Secondary | Progression-free Survival (PFS) (Phase II) (Subset Analysis) | From study entry to time of progression or death, whichever occurs first, assessed up to 5 years | Will be assessed according to RECIST 1.1. Subset analyses within categorized, important exploratory laboratory parameters will examine the treatment effect on PFS. The effect of treatment on PFS will be examined within each of these subsets using a log-rank test or a Cox PH model. Interest will center on whether the hazard of PFS changes from one group to another. The impact of the biomarkers on PFS will be assessed using log-rank tests or Cox PH models. |
| Secondary | Number of Patients Who Have Total Gross Resection (Phase II) | At the time of surgery (surgery occurred within 6 weeks after completion of cycle 3, as soon as nadir counts permit and surgery deemed safe by investigator) | The outcome is whether there is a total gross resection rate at time of interval cytoreductive surgery among those who had surgery. |
| Secondary | Number of Participants With Complete Pathological Response (Phase II) | At the time of tumor reductive surgery or biopsy after 3 cycles (i.e. after 63 days). | At the time of TRS, complete pathologic response is defined as no evidence of disease on radiographic imaging at the time of radiographic tumor measurement just prior to TRS, no visible or palpable tumor at the time of surgical exploration, and no pathologic evidence of disease in tissue specimens obtained from TRS. |
| Secondary | Overall Survival (OS) (Phase II) | The average (median) OS follow-up time is 38 months. | The effect of treatment on OS will be conducted with a Kaplan-Meier analysis and reported as median survival times. |
| Other | Change in Cancer Stem Cells (CSC) Observed in Tissue | Baseline up to 63 days (3 cycles) | Landmark analyses will be conducted to see if changes in CSC are associated with PFS. The predictive value of CSC will be formally examined with a Cox model using an interaction term with treatment. Subset analyses will be conducted as well in the event that a formal analysis fails to reject the null hypothesis. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose-limiting Toxicities (Phase I) | 42 days (2 cycles) | Eligible | participants | NUMBER |
| PRIMARY | Progression-free Survival (PFS) (Phase II) | The maximum follow-up time for PFS is 57 months. | Eligible for PFS analysis | months | MEDIAN |
| SECONDARY | Number of Participants With Grade 3 or Higher AE (Phase I and II) | Serious and other adverse events were collected from baseline until 30 days after last treatment, an average of 10 months. | Eligible | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Patients Who Could Not Receive Surgery Within the Defined Timeframe for Reasons Other Than Non-response, Disease Progression, or Medical Contraindications (Phase I) | Up to 6 weeks | Eligible | participants | NUMBER |
| SECONDARY | Number of Patients Who Discontinue Ruxolitinib in the First 3 Months of Maintenance Therapy Due to Toxicity (Phase I) | Up to 3 months in the maintenance phase | Eligible | participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) (Phase II) (Subset Analysis) | From study entry to time of progression or death, whichever occurs first, assessed up to 5 years | |||
| SECONDARY | Number of Patients Who Have Total Gross Resection (Phase II) | At the time of surgery (surgery occurred within 6 weeks after completion of cycle 3, as soon as nadir counts permit and surgery deemed safe by investigator) | Eligible | participants | NUMBER |
| SECONDARY | Number of Participants With Complete Pathological Response (Phase II) | At the time of tumor reductive surgery or biopsy after 3 cycles (i.e. after 63 days). | Eligible | participants | NUMBER |
| SECONDARY | Overall Survival (OS) (Phase II) | The average (median) OS follow-up time is 38 months. | Eligible | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Change in Cancer Stem Cells (CSC) Observed in Tissue | Baseline up to 63 days (3 cycles) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose-limiting Toxicities (Phase I) | Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 2 | participants | ||
| Dose-limiting Toxicities (Phase I) | Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 3 | participants | ||
| Progression-free Survival (PFS) (Phase II) | Phase 2 - Arm I (Paclitaxel and Carboplatin) | 11.63 | 95% Confidence Interval 10.32 to 14.39 | months | |
| Progression-free Survival (PFS) (Phase II) | Phase 2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 14.55 | 95% Confidence Interval 11.89 to 16.92 | months | |
| Number of Participants With Grade 3 or Higher AE (Phase I and II) | Phase 2 - Arm I (Paclitaxel and Carboplatin) | 32 | Participants | ||
| Number of Participants With Grade 3 or Higher AE (Phase I and II) | Phase 2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 81 | Participants | ||
| Number of Participants With Grade 3 or Higher AE (Phase I and II) | Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 1 | Participants | ||
| Number of Participants With Grade 3 or Higher AE (Phase I and II) | Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 3 | Participants | ||
| Frequency of Patients Who Could Not Receive Surgery Within the Defined Timeframe for Reasons Other Than Non-response, Disease Progression, or Medical Contraindications (Phase I) | Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 0 | participants | ||
| Frequency of Patients Who Could Not Receive Surgery Within the Defined Timeframe for Reasons Other Than Non-response, Disease Progression, or Medical Contraindications (Phase I) | Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 3 | participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 - Dose Level 1 | STARTED | Phase 2 - Arm I (Paclitaxel and Carboplatin) | 0 | |
| Phase 1 - Dose Level 1 | STARTED | Phase 2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 0 | |
| Phase 1 - Dose Level 1 | STARTED | Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 7 | |
| Phase 1 - Dose Level 1 | STARTED | Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 0 | |
| Phase 1 - Dose Level 1 | COMPLETED | Phase 2 - Arm I (Paclitaxel and Carboplatin) | 0 | |
| Phase 1 - Dose Level 1 | COMPLETED | Phase 2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 0 | |
| Phase 1 - Dose Level 1 | COMPLETED | Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 7 | |
| Phase 1 - Dose Level 1 | COMPLETED | Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 0 | |
| Phase 1 - Dose Level 1 | NOT COMPLETED | Phase 2 - Arm I (Paclitaxel and Carboplatin) | 0 | |
| Phase 1 - Dose Level 1 | NOT COMPLETED | Phase 2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events1,156
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 2 - Arm I (Paclitaxel and Carboplatin) | 28 | 42 | |
| other | Anemia | Blood and lymphatic system disorders | Phase 2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 70 | 88 | |
| other | Anemia | Blood and lymphatic system disorders | Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 1 | 7 | |
| other | Anemia | Blood and lymphatic system disorders | Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 1 | 10 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Phase 2 - Arm I (Paclitaxel and Carboplatin) | 0 | 42 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Phase 2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 6 | 88 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 0 | 7 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 0 | 10 | |
| other | Atrial fibrillation | Cardiac disorders | Phase 2 - Arm I (Paclitaxel and Carboplatin) | 3 | 42 | |
| other | Atrial fibrillation | Cardiac disorders | Phase 2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 0 | 88 |
1 to 10 of 1,156Source ClinicalTrials.gov
See all 1,156 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 2 - Arm I (Paclitaxel and Carboplatin) | 14 | 42 |
| Total, all-cause mortality | Phase 2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 25 | 88 |
| Total, all-cause mortality | Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 4 | 7 |
| Total, all-cause mortality | Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 10 | 10 |
| Total, other adverse events | Phase 2 - Arm I (Paclitaxel and Carboplatin) | 41 | 42 |
| Total, other adverse events | Phase 2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 88 | 88 |
| Total, other adverse events | Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 1 | 7 |
| Total, other adverse events | Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 3 | 10 |
| Total, serious adverse events | Phase 2 - Arm I (Paclitaxel and Carboplatin) | 9 | 42 |
| Total, serious adverse events | Phase 2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) | 42 | 88 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38776484 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel and Carboplatin) vs Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin): Number of Patients Who Discontinue Ruxolitinib in the First 3 Months of Maintenance Therapy Due to Toxicity (Phase I) | Trial comparisons |
Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) vs Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin): Frequency of Patients Who Could Not Receive Surgery Within the Defined Timeframe for Reasons Other Than Non-response, Disease Progression, or Medical Contraindications (Phase I) | Trial comparisons |
| Arm I (Paclitaxel and Carboplatin) vs Arm II (Ruxolitinib, Paclitaxel, and Carboplatin): Number of Patients Who Have Total Gross Resection (Phase II) | Trial comparisons |
| Arm I (Paclitaxel and Carboplatin) vs Arm II (Ruxolitinib, Paclitaxel, and Carboplatin): Number of Participants With Complete Pathological Response (Phase II) | Trial comparisons |
| Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) vs Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin): Dose-limiting Toxicities (Phase I) | 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.
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