Trial Outcomes & Findings for Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer (NCT NCT03617679)
NCT ID: NCT03617679
Last Updated: 2025-02-11
Results Overview
Progression free survival is defined as cycle 1 day 1 (C1D1) till the time of progression as determined by RECIST 1.1 criteria or death.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
Up to 48 months.
Results posted on
2025-02-11
Participant Flow
Participant milestones
| Measure |
Active Ingredient
1:1 Randomization. Participants in this arm receive the active ingredient medication.
Rucaparib: Participants allocated to the active ingredient arm will receive Rucaparib twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Medication should be taken around the same time every day, with 8 or more ounces of water.
|
Placebo
1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).
Placebo Oral Tablet: Participants allocated to the placebo arm will receive a placebo tablet (that looks identical to the active ingredient tablet) twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Tablet should be taken around the same time every day, with 8 or more ounces of water.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
40
|
|
Overall Study
COMPLETED
|
39
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Active Ingredient
n=39 Participants
1:1 Randomization. Participants in this arm receive the active ingredient medication.
Rucaparib: Participants allocated to the active ingredient arm will receive Rucaparib twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Medication should be taken around the same time every day, with 8 or more ounces of water.
|
Placebo
n=40 Participants
1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).
Placebo Oral Tablet: Participants allocated to the placebo arm will receive a placebo tablet (that looks identical to the active ingredient tablet) twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Tablet should be taken around the same time every day, with 8 or more ounces of water.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
n=5 Participants
|
67 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
40 participants
n=7 Participants
|
79 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 48 months.Progression free survival is defined as cycle 1 day 1 (C1D1) till the time of progression as determined by RECIST 1.1 criteria or death.
Outcome measures
| Measure |
Active Ingredient
n=39 Participants
1:1 Randomization. Participants in this arm receive the active ingredient medication.
Rucaparib: Participants allocated to the active ingredient arm will receive Rucaparib twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Medication should be taken around the same time every day, with 8 or more ounces of water.
|
Placebo
n=40 Participants
1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).
Placebo Oral Tablet: Participants allocated to the placebo arm will receive a placebo tablet (that looks identical to the active ingredient tablet) twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Tablet should be taken around the same time every day, with 8 or more ounces of water.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
28.1 months
Interval 12.8 to
insufficient number of participants with events
|
8.7 months
Interval 5.4 to 16.7
|
SECONDARY outcome
Timeframe: Up to 48 months.Overall survival is defined as cycle 1 day 1 (C1D1) till the time of death.
Outcome measures
| Measure |
Active Ingredient
n=39 Participants
1:1 Randomization. Participants in this arm receive the active ingredient medication.
Rucaparib: Participants allocated to the active ingredient arm will receive Rucaparib twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Medication should be taken around the same time every day, with 8 or more ounces of water.
|
Placebo
n=40 Participants
1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).
Placebo Oral Tablet: Participants allocated to the placebo arm will receive a placebo tablet (that looks identical to the active ingredient tablet) twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Tablet should be taken around the same time every day, with 8 or more ounces of water.
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Interval 34.8 to
insufficient number of participants with events
|
28.4 months
Interval 19.0 to
insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 48 months.Safety and tolerability analysis of Rucaparib will be summarized by dose and severity as assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5 and relationship to study drug.
Outcome measures
| Measure |
Active Ingredient
n=39 Participants
1:1 Randomization. Participants in this arm receive the active ingredient medication.
Rucaparib: Participants allocated to the active ingredient arm will receive Rucaparib twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Medication should be taken around the same time every day, with 8 or more ounces of water.
|
Placebo
n=40 Participants
1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).
Placebo Oral Tablet: Participants allocated to the placebo arm will receive a placebo tablet (that looks identical to the active ingredient tablet) twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Tablet should be taken around the same time every day, with 8 or more ounces of water.
|
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
|
37 Participants
|
27 Participants
|
Adverse Events
Active Ingredient
Serious events: 3 serious events
Other events: 37 other events
Deaths: 1 deaths
Placebo
Serious events: 1 serious events
Other events: 27 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Active Ingredient
n=39 participants at risk
1:1 Randomization. Participants in this arm receive the active ingredient medication.
Rucaparib: Participants allocated to the active ingredient arm will receive Rucaparib twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Medication should be taken around the same time every day, with 8 or more ounces of water.
|
Placebo
n=40 participants at risk
1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).
Placebo Oral Tablet: Participants allocated to the placebo arm will receive a placebo tablet (that looks identical to the active ingredient tablet) twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Tablet should be taken around the same time every day, with 8 or more ounces of water.
|
|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
2.6%
1/39 • Number of events 1 • 4 years and 8 months.
|
0.00%
0/40 • 4 years and 8 months.
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
5.1%
2/39 • Number of events 2 • 4 years and 8 months.
|
0.00%
0/40 • 4 years and 8 months.
|
|
Investigations
elevated ALT/AST
|
0.00%
0/39 • 4 years and 8 months.
|
2.5%
1/40 • Number of events 1 • 4 years and 8 months.
|
|
Investigations
neutropenia
|
2.6%
1/39 • Number of events 1 • 4 years and 8 months.
|
0.00%
0/40 • 4 years and 8 months.
|
|
Gastrointestinal disorders
nausea
|
2.6%
1/39 • Number of events 1 • 4 years and 8 months.
|
0.00%
0/40 • 4 years and 8 months.
|
Other adverse events
| Measure |
Active Ingredient
n=39 participants at risk
1:1 Randomization. Participants in this arm receive the active ingredient medication.
Rucaparib: Participants allocated to the active ingredient arm will receive Rucaparib twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Medication should be taken around the same time every day, with 8 or more ounces of water.
|
Placebo
n=40 participants at risk
1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).
Placebo Oral Tablet: Participants allocated to the placebo arm will receive a placebo tablet (that looks identical to the active ingredient tablet) twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Tablet should be taken around the same time every day, with 8 or more ounces of water.
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
59.0%
23/39 • Number of events 23 • 4 years and 8 months.
|
22.5%
9/40 • Number of events 9 • 4 years and 8 months.
|
|
General disorders
fatigue
|
61.5%
24/39 • Number of events 24 • 4 years and 8 months.
|
27.5%
11/40 • Number of events 11 • 4 years and 8 months.
|
|
Blood and lymphatic system disorders
anemia
|
66.7%
26/39 • Number of events 26 • 4 years and 8 months.
|
20.0%
8/40 • Number of events 8 • 4 years and 8 months.
|
|
Investigations
thrombocytopenia
|
38.5%
15/39 • Number of events 15 • 4 years and 8 months.
|
12.5%
5/40 • Number of events 5 • 4 years and 8 months.
|
|
Investigations
elevated ALT/AST
|
33.3%
13/39 • Number of events 13 • 4 years and 8 months.
|
0.00%
0/40 • 4 years and 8 months.
|
|
Nervous system disorders
Dysgeusia
|
20.5%
8/39 • Number of events 8 • 4 years and 8 months.
|
0.00%
0/40 • 4 years and 8 months.
|
|
Investigations
neutropenia
|
23.1%
9/39 • Number of events 9 • 4 years and 8 months.
|
17.5%
7/40 • Number of events 7 • 4 years and 8 months.
|
|
Investigations
elevated alkaline phosphatase
|
10.3%
4/39 • Number of events 4 • 4 years and 8 months.
|
2.5%
1/40 • Number of events 1 • 4 years and 8 months.
|
|
Nervous system disorders
dizziness
|
10.3%
4/39 • Number of events 4 • 4 years and 8 months.
|
0.00%
0/40 • 4 years and 8 months.
|
|
Metabolism and nutrition disorders
anorexia
|
7.7%
3/39 • Number of events 3 • 4 years and 8 months.
|
2.5%
1/40 • Number of events 1 • 4 years and 8 months.
|
|
Gastrointestinal disorders
diarrhea
|
5.1%
2/39 • Number of events 2 • 4 years and 8 months.
|
10.0%
4/40 • Number of events 4 • 4 years and 8 months.
|
|
Gastrointestinal disorders
dry mouth
|
5.1%
2/39 • Number of events 2 • 4 years and 8 months.
|
5.0%
2/40 • Number of events 2 • 4 years and 8 months.
|
|
Skin and subcutaneous tissue disorders
rash
|
5.1%
2/39 • Number of events 2 • 4 years and 8 months.
|
0.00%
0/40 • 4 years and 8 months.
|
|
Vascular disorders
hot flashes
|
5.1%
2/39 • Number of events 2 • 4 years and 8 months.
|
0.00%
0/40 • 4 years and 8 months.
|
|
Investigations
elevated creatinine
|
10.3%
4/39 • Number of events 4 • 4 years and 8 months.
|
0.00%
0/40 • 4 years and 8 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place