Trial Outcomes & Findings for Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT02713386)

Last Updated: 2025-05-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

147 participants

Primary outcome timeframe

42 days (2 cycles)

Results posted on

2025-05-25

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 2 - Arm I (Paclitaxel and Carboplatin) See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo TRS	Phase 2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) See Detailed Description. Carboplatin: Given IV (AUC 5) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (15 mg bid)	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) See Detailed Description. Carboplatin: Given IV (AUC 6) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (10 mg bid)
Phase 1 - Dose Level 1 STARTED	0	0	7	0
Phase 1 - Dose Level 1 COMPLETED	0	0	7	0
Phase 1 - Dose Level 1 NOT COMPLETED	0	0	0	0
Phase 1 - Dose Level 2 STARTED	0	0	0	10
Phase 1 - Dose Level 2 COMPLETED	0	0	0	10
Phase 1 - Dose Level 2 NOT COMPLETED	0	0	0	0
Phase 2 STARTED	42	88	0	0
Phase 2 COMPLETED	42	88	0	0
Phase 2 NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 2 - Arm I (Paclitaxel and Carboplatin) n=42 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo TRS	Phase 2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=88 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=7 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=10 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Total n=147 Participants Total of all reporting groups
Age, Customized 20 - 29 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Customized 30 - 39 years	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Age, Customized 40 - 49 years	1 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants
Age, Customized 50 - 59 years	6 Participants n=5 Participants	19 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	28 Participants n=21 Participants
Age, Customized 60 - 69 years	11 Participants n=5 Participants	30 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	47 Participants n=21 Participants
Age, Customized 70 - 79 years	22 Participants n=5 Participants	27 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	54 Participants n=21 Participants
Age, Customized >= 80 years	0 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	88 Participants n=7 Participants	7 Participants n=5 Participants	10 Participants n=4 Participants	147 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	12 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	79 Participants n=7 Participants	7 Participants n=5 Participants	9 Participants n=4 Participants	129 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	80 Participants n=7 Participants	6 Participants n=5 Participants	9 Participants n=4 Participants	133 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants

PRIMARY outcome

Timeframe: 42 days (2 cycles)

Population: Eligible

Outcome measures

Outcome measures
Measure	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=7 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=7 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) See Detailed Description. Carboplatin: Given IV (AUC 5) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (15 mg bid)	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) See Detailed Description. Carboplatin: Given IV (AUC 6) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (10 mg bid)
Dose-limiting Toxicities (Phase I)	2 participants	3 participants	—	—

PRIMARY outcome

Timeframe: The maximum follow-up time for PFS is 57 months.

Population: Eligible for PFS analysis

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

Outcome measures

Outcome measures
Measure	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=42 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=88 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) See Detailed Description. Carboplatin: Given IV (AUC 5) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (15 mg bid)	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) See Detailed Description. Carboplatin: Given IV (AUC 6) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (10 mg bid)
Progression-free Survival (PFS) (Phase II)	11.63 months Interval 10.32 to 14.39	14.55 months Interval 11.89 to 16.92	—	—

SECONDARY outcome

Timeframe: Serious and other adverse events were collected from baseline until 30 days after last treatment, an average of 10 months.

Population: Eligible

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).

Outcome measures

Outcome measures
Measure	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=42 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=88 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=7 Participants See Detailed Description. Carboplatin: Given IV (AUC 5) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (15 mg bid)	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=10 Participants See Detailed Description. Carboplatin: Given IV (AUC 6) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (10 mg bid)
Number of Participants With Grade 3 or Higher AE (Phase I and II)	32 Participants	81 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: Eligible

Frequencies will be given by the dose-level administered.

Outcome measures

Outcome measures
Measure	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=7 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=10 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) See Detailed Description. Carboplatin: Given IV (AUC 5) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (15 mg bid)	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) See Detailed Description. Carboplatin: Given IV (AUC 6) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (10 mg bid)
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)	0 participants	3 participants	—	—

SECONDARY outcome

Timeframe: Up to 3 months in the maintenance phase

Population: Eligible

Number of patients who discontinue ruxolitinib in the first 3 months of maintenance therapy due to toxicity (Phase I)

Outcome measures

Outcome measures
Measure	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=3 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=3 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) See Detailed Description. Carboplatin: Given IV (AUC 5) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (15 mg bid)	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) See Detailed Description. Carboplatin: Given IV (AUC 6) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (10 mg bid)
Number of Patients Who Discontinue Ruxolitinib in the First 3 Months of Maintenance Therapy Due to Toxicity (Phase I)	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Population: Eligible

The outcome is whether there is a total gross resection rate at time of interval cytoreductive surgery among those who had surgery.

Outcome measures

Outcome measures
Measure	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=35 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=77 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) See Detailed Description. Carboplatin: Given IV (AUC 5) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (15 mg bid)	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) See Detailed Description. Carboplatin: Given IV (AUC 6) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (10 mg bid)
Number of Patients Who Have Total Gross Resection (Phase II)	20 participants	49 participants	—	—

SECONDARY outcome

Timeframe: At the time of tumor reductive surgery or biopsy after 3 cycles (i.e. after 63 days).

Population: Eligible

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.

Outcome measures

Outcome measures
Measure	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=35 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=77 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) See Detailed Description. Carboplatin: Given IV (AUC 5) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (15 mg bid)	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) See Detailed Description. Carboplatin: Given IV (AUC 6) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (10 mg bid)
Number of Participants With Complete Pathological Response (Phase II)	0 participants	1 participants	—	—

SECONDARY outcome

Timeframe: The average (median) OS follow-up time is 38 months.

Population: Eligible

The effect of treatment on OS will be conducted with a Kaplan-Meier analysis and reported as median survival times.

Outcome measures

Outcome measures
Measure	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=42 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) n=88 Participants See Detailed Description. Carboplatin: Given IV Paclitaxel: Given IV Ruxolitinib Phosphate: Given PO Therapeutic Conventional Surgery: Undergo TRS	Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) See Detailed Description. Carboplatin: Given IV (AUC 5) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (15 mg bid)	Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin) See Detailed Description. Carboplatin: Given IV (AUC 6) Paclitaxel: Given IV (70 mg/m2/week) Ruxolitinib Phosphate: Given PO (10 mg bid)
Overall Survival (OS) (Phase II)	30.8 months Interval 24.6 to Due to insufficient sample size, lack of follow-up time or a lack of a sufficient probability of death, the upper limit of the 95% CI for Arm I is not able to be estimated (NA).	NA months Interval 30.9 to Due to insufficient sample size, lack of follow-up time or a lack of a sufficient probability of death, the median and upper limit of the 95% CI for Arm II is not able to be estimated (NA).	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 63 days (3 cycles)

The impact of baseline values on PFS and OS can be assessed for prognostic and predictive significance with log-rank statistics and Cox models. The impact of changes in CRP values on PFS and OS can be examined with landmark analyses or as time dependent covariates.

Outcome measures

Outcome data not reported

Adverse Events

Phase 2 - Arm I (Paclitaxel and Carboplatin)

Serious events: 9 serious events

Other events: 41 other events

Deaths: 14 deaths

Phase 2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin)

Serious events: 42 serious events

Other events: 88 other events

Deaths: 25 deaths

Phase 1 - DL1 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 4 deaths

Phase 1 - DL2 - Arm II (Ruxolitinib, Paclitaxel, and Carboplatin)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 10 deaths

Serious adverse events

Other adverse events

Additional Information

Christopher Purdy on behalf of Michael Sill, PhD

NRG Oncology

Phone: 716-845-1300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60