Trial · NCT02101788

Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer

NCT02101788, Phase 2, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2020-09-29

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer. Trials, record NCT02101788. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02101788

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer
NCT number: NCT02101788
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 260 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Borderline Ovarian Serous Tumor, Micropapillary Serous Carcinoma, Ovarian Serous Adenocarcinoma, Primary Peritoneal Serous Adenocarcinoma, Recurrent Ovarian Low Grade Serous Adenocarcinoma, Recurrent Primary Peritoneal Serous Adenocarcinoma
Interventions: Letrozole, Paclitaxel, Pegylated Liposomal Doxorubicin Hydrochloride, Quality-of-Life Assessment, Questionnaire Administration, Tamoxifen Citrate, Topotecan, Trametinib Dimethyl Sulfoxide
First posted: 2014-04-02
Last updated: 2026-08-04
Results first posted: 2020-09-29
Limitations and caveats: The pERK expression analysis is still under development, and will not be available for approximately 2 - 3 years.

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS)	Time from study entry to time of progression or death, an average of 7 months for arm A and 13 months for arm B	Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan.Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the PFS endpoint definition.
Secondary	Incidence of Adverse Events (AEs)	During treatment period and up to 100 days after stopping the study treatment	Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy. Excludes AEs observed among control patients treated with trametinib after crossover.Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the AE endpoint definition.
Secondary	Overall Survival	Time from study entry to time of death or date of last contact, an average of 29 months for arm A and 37 months for arm B	Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact. Patients with disease progression on the Control arm were allowed to cross over to the trametinib arm. Per the protocol, the intent-to-treat OS analysis was not adjusted for crossover.
Secondary	Objective Tumor Response Rate (Complete Response and Partial Response)	Time from study entry to time of progression or death, an average of 7 months for arm A and 13 months for arm B	The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria.
Secondary	Patients Reported Acute Quality of Life	1. baseline (prior to cycle 1), 12 weeks (prior to cycle 4), 24 weeks (4 weeks post cycle 6), 36 weeks post cycle 1, 52 weeks post cycle 1.	Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). . The FACT-O TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-O TOI items provide valid answers and all of the component subscales have valid scores. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL. Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the quality of life endpoint definition
Secondary	Patient Reported Acute Peripheral Neuropathy Symptoms	Up to 52 weeks	Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms
Secondary	Progression Free Survival	Time from study entry to time of progression or death, an average of 7 months for SOC and 13 months for the treatment (Trametinib) arm.	Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan. RECIST v1.1 defines progression as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Secondary	pERK Expression	Baseline	Will be quantified using the H-score derived from the immunohistochemistry analysis of patient tumor tissue and is expected to present as a continuous measure. will consider the prognostic and predictive abilities of pERK relative to objective response rate (ORR) or PFS. Analysis of the dichotomous markers will be supported by Kaplan Meier plots, and forest plots of the odds-ratio and hazard ratio estimates. Duration of response will be depicted using swimmer plots, with median duration estimated using Kaplan Meier methods. The multivariable models will include covariate adjustment for geographic region, performance status and number of prior regimens, presented using effect coding. The adjusted hazard- and odds- ratio estimates from the multivariable models will be supported by nominal p-values and 2-sided, 95% confidence intervals. Confidence intervals will be interpreted as the plausible range of values for the true (unobserved) ratio that is supported by the data.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival (PFS)	Time from study entry to time of progression or death, an average of 7 months for arm A and 13 months for arm B	All randomized patients	months	MEDIAN
SECONDARY	Incidence of Adverse Events (AEs)	During treatment period and up to 100 days after stopping the study treatment	Treated with randomized therapy	participants	NUMBER
SECONDARY	Overall Survival	Time from study entry to time of death or date of last contact, an average of 29 months for arm A and 37 months for arm B	All randomized patients	Months	MEDIAN
SECONDARY	Objective Tumor Response Rate (Complete Response and Partial Response)	Time from study entry to time of progression or death, an average of 7 months for arm A and 13 months for arm B	Randomized patients	participants	NUMBER
SECONDARY	Patients Reported Acute Quality of Life	1. baseline (prior to cycle 1), 12 weeks (prior to cycle 4), 24 weeks (4 weeks post cycle 6), 36 weeks post cycle 1, 52 weeks post cycle 1.	Patients who provided baseline and ≥ 1 follow-up assessment	score on a scale	MEAN
SECONDARY	Patient Reported Acute Peripheral Neuropathy Symptoms	Up to 52 weeks	Patients that provided baseline and ≥ 1 follow-up assessment	score on a scale	MEAN
SECONDARY	Progression Free Survival	Time from study entry to time of progression or death, an average of 7 months for SOC and 13 months for the treatment (Trametinib) arm.	Patients with sufficient tissue for analysis	Months	MEDIAN
SECONDARY	pERK Expression	Baseline

Source ClinicalTrials.gov

Results by group50

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression-free Survival (PFS)	Arm A - Control Arm		7.2	95% Confidence Interval 5.6 to 9.9	months
Progression-free Survival (PFS)	Arm B - Experimental Arm		13.0	95% Confidence Interval 9.9 to 15.0	months
Incidence of Adverse Events (AEs)	Arm A - Control Arm	Abdominal pain	22		participants
Incidence of Adverse Events (AEs)	Arm B - Experimental Arm	Abdominal pain	7		participants
Incidence of Adverse Events (AEs)	Arm A - Control Arm	Anemia	12		participants
Incidence of Adverse Events (AEs)	Arm B - Experimental Arm	Anemia	16		participants
Incidence of Adverse Events (AEs)	Arm A - Control Arm	Diarrhea	4		participants
Incidence of Adverse Events (AEs)	Arm B - Experimental Arm	Diarrhea	13		participants
Incidence of Adverse Events (AEs)	Arm A - Control Arm	Fatigue	5		participants
Incidence of Adverse Events (AEs)	Arm B - Experimental Arm	Fatigue	10		participants

1 to 10 of 50Source ClinicalTrials.gov

See all 50 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A - Control Arm	130
Overall Study	STARTED	Arm B - Experimental Arm	130
Overall Study	Crossover From Arm A to Arm B	Arm A - Control Arm	88
Overall Study	Crossover From Arm A to Arm B	Arm B - Experimental Arm	0
Overall Study	COMPLETED	Arm A - Control Arm	120
Overall Study	COMPLETED	Arm B - Experimental Arm	116
Overall Study	NOT COMPLETED	Arm A - Control Arm	10
Overall Study	NOT COMPLETED	Arm B - Experimental Arm	14

Source ClinicalTrials.gov

Adverse events1,155

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
other	Thrombotic Thrombocytopenic Purpura	Blood and lymphatic system disorders	Arm A - Control Arm	1	127
other	Thrombotic Thrombocytopenic Purpura	Blood and lymphatic system disorders	Arm B - Experimental Arm	1	127
other	Thrombotic Thrombocytopenic Purpura	Blood and lymphatic system disorders	Crossover From Control to Experimental Arm	0	88
other	Lymph Node Pain	Blood and lymphatic system disorders	Arm A - Control Arm	1	127
other	Lymph Node Pain	Blood and lymphatic system disorders	Arm B - Experimental Arm	1	127
other	Lymph Node Pain	Blood and lymphatic system disorders	Crossover From Control to Experimental Arm	1	88
other	Anemia	Blood and lymphatic system disorders	Arm A - Control Arm	54	127
other	Anemia	Blood and lymphatic system disorders	Arm B - Experimental Arm	66	127
other	Anemia	Blood and lymphatic system disorders	Crossover From Control to Experimental Arm	51	88
other	Febrile Neutropenia	Blood and lymphatic system disorders	Arm A - Control Arm	0	127

1 to 10 of 1,155Source ClinicalTrials.gov

See all 1,155 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A - Control Arm	60	127
Total, all-cause mortality	Arm B - Experimental Arm	51	127
Total, all-cause mortality	Crossover From Control to Experimental Arm	3	88
Total, other adverse events	Arm A - Control Arm	124	127
Total, other adverse events	Arm B - Experimental Arm	127	127
Total, other adverse events	Crossover From Control to Experimental Arm	88	88
Total, serious adverse events	Arm A - Control Arm	43	127
Total, serious adverse events	Arm B - Experimental Arm	45	127
Total, serious adverse events	Crossover From Control to Experimental Arm	25	88

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35123694	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
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	NIH RePORTER
P50CA083639	The University of Texas M. D. Anderson Cancer Center SPORE in Ovarian Cancer	BAST, ROBERT C	UNIVERSITY OF TX MD ANDERSON CAN CTR	NATIONAL CANCER INSTITUTE	1999 to 2015	NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Arm A - Control Arm vs Arm B - Experimental Arm: Objective Tumor Response Rate (Complete Response and Partial Response)

Source 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02101788

GET https://conductscience.org/api/trials/v1/NCT02101788/results?page=2

API reference For AI assistants