Trial Outcomes & Findings for PLX2853 as a Single Agent in Advanced Gynecological Malignancies and in Combination With Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer (NCT NCT04493619)
NCT ID: NCT04493619
Last Updated: 2024-11-04
Results Overview
Overall response rate as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
37 participants
Primary outcome timeframe
From 8 weeks of treatment for only PLX2853 (Cycle 3 Day 1; 28 days per cycle) until completion of long term follow-up, an average of 6 months.
Results posted on
2024-11-04
Participant Flow
Participant milestones
| Measure |
Phase 2a
PLX2853 80 mg once/day monotherapy
|
Phase 1b Combination
PLX2853 40 mg once/daily + carboplatin once every 28 days
|
Phase 1b
PLX2853 80 mg once/daily + carboplatin once every 28 days
|
Phase 2a Combination
PLX2853 40 mg once/daily + carboplatin once every 28 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
3
|
7
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
3
|
7
|
13
|
Reasons for withdrawal
| Measure |
Phase 2a
PLX2853 80 mg once/day monotherapy
|
Phase 1b Combination
PLX2853 40 mg once/daily + carboplatin once every 28 days
|
Phase 1b
PLX2853 80 mg once/daily + carboplatin once every 28 days
|
Phase 2a Combination
PLX2853 40 mg once/daily + carboplatin once every 28 days
|
|---|---|---|---|---|
|
Overall Study
Death
|
4
|
3
|
3
|
4
|
|
Overall Study
Study discontinued early
|
10
|
0
|
4
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
Baseline Characteristics
PLX2853 as a Single Agent in Advanced Gynecological Malignancies and in Combination With Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer
Baseline characteristics by cohort
| Measure |
PLX2853 Phase 2a Monotherapy
n=14 Participants
Up to 26 evaluable subjects with ARID1A mutation-positive advanced gynecological malignancies will be enrolled.
PLX2853: PLX2853 tablets
|
PLX2853 (40 mg) + Carboplatin Phase 1b
n=3 Participants
Phase 1b (PLX2853 + carboplatin combination): Up to 15 evaluable subjects with platinum-resistant EOC will be enrolled.
PLX2853: PLX2853 tablets
Carboplatin: Carboplatin IV injection, 5 mg•min/mL
|
PLX2853 (80 mg) + Carboplatin Phase 1b
n=7 Participants
Phase 1b (PLX2853 + carboplatin combination): Up to 15 evaluable subjects with platinum-resistant EOC will be enrolled.
PLX2853: PLX2853 tablets
Carboplatin: Carboplatin IV injection, 5 mg•min/mL
|
PLX2853 + Carboplatin Phase 2a Combination Therapy
n=13 Participants
Phase 2a (PLX2853 + carboplatin combination): Up to 26 evaluable subjects with platinum-resistant EOC will be enrolled.
PLX2853: PLX2853 tablets
Carboplatin: Carboplatin IV injection, 5 mg•min/mL
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
37 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
3 participants
n=7 Participants
|
3 participants
n=31 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=99 Participants
|
0 participants
n=107 Participants
|
7 participants
n=206 Participants
|
10 participants
n=7 Participants
|
34 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From 8 weeks of treatment for only PLX2853 (Cycle 3 Day 1; 28 days per cycle) until completion of long term follow-up, an average of 6 months.Population: This outcome measure was not evaluated. The study was discontinued early and continued collection of disease status, which is required to determine overall response rate (ORR), was not conducted, therefore this measure is not reportable.
Overall response rate as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From time of first dose of PLX2853 and carboplatin until 30 days of end of treatment an average of 6 months.Population: Note that the MTD was not reached as the study terminated early.
MTD is defined as the maximum tolerated dose, which is determined from dose-limiting toxicity. If DLTs are observed in 2 or more of 6 subjects (or ≥33% of the cohort) at a dose level, the dose at which this occurs will be considered intolerable and the MTD will have been exceeded. The MTD is the dose below the intolerable dose. RP2D is the recommended Phase 2 dose, which was determined to be 80 mg
Outcome measures
| Measure |
PLX2853 Phase 2a Monotherapy
n=14 Participants
Subjects with ARID1A mutation-positive advanced gynecological malignancies will be enrolled.
|
PLX2853 + Carboplatin Phase 1b/2a Combination Therapy
n=23 Participants
Subjects with platinum-resistant EOC
|
|---|---|---|
|
Phase 1b (PLX2853 + Carboplatin Combination): Establish the Number of Participants Reaching MTD/RP2D for the Combination of PLX2853 and Carboplatin
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From 8 weeks of treatment with PLX2853 and Carboplatin (Cycle 3 Day 1; 28 days per cycle) until completion of long term follow-up, an average of 6 months.Population: This outcome measure was not evaluated. The study was discontinued early and continued collection of disease status, which is required to determine overall response rate (ORR), was not conducted, therefore this measure is not reportable.
Overall response rate as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Outcome measures
Outcome data not reported
Adverse Events
PLX2853 Phase 2a Monotherapy
Serious events: 6 serious events
Other events: 14 other events
Deaths: 5 deaths
PLX2853 + Carboplatin Phase 1b/2a Combination Therapy
Serious events: 10 serious events
Other events: 20 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
PLX2853 Phase 2a Monotherapy
n=14 participants at risk
Up to 26 evaluable subjects with ARID1A mutation-positive advanced gynecological malignancies will be enrolled.
PLX2853: PLX2853 tablets
|
PLX2853 + Carboplatin Phase 1b/2a Combination Therapy
n=23 participants at risk
Phase 1b (PLX2853 + carboplatin combination): Up to 15 evaluable subjects with platinum-resistant EOC will be enrolled.
Phase 2a (PLX2853 + carboplatin combination): Up to 26 evaluable subjects with platinum-resistant EOC will be enrolled.
PLX2853: PLX2853 tablets
Carboplatin: Carboplatin IV injection, 5 mg•min/mL
|
|---|---|---|
|
Infections and infestations
sepsis
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
0.00%
0/23 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Gastrointestinal disorders
abdominal pain
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
0.00%
0/23 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Blood and lymphatic system disorders
anemia
|
14.3%
2/14 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
0.00%
0/23 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Hepatobiliary disorders
hepatic hematoma
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
0.00%
0/23 • Through 30 days after last dose of study drug, an average of 6 months
|
|
General disorders
fatigue
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
0.00%
0/23 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Gastrointestinal disorders
large intenstinal obstruction
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
0.00%
0/23 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Gastrointestinal disorders
small intestinal obstruction
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Infections and infestations
abdominal infection
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Psychiatric disorders
confusional state
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
8.7%
2/23 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Gastrointestinal disorders
duodenal obstruction
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Gastrointestinal disorders
gastric haemmorhage
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Metabolism and nutrition disorders
hyponatremia
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Injury, poisoning and procedural complications
infusion related reaction
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Nervous system disorders
lethargy
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Gastrointestinal disorders
obstruction gastric
|
14.3%
2/14 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Infections and infestations
pneumonia
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Injury, poisoning and procedural complications
procedural pneumothorax
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
General disorders
pyrexia
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Nervous system disorders
syncope
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
Other adverse events
| Measure |
PLX2853 Phase 2a Monotherapy
n=14 participants at risk
Up to 26 evaluable subjects with ARID1A mutation-positive advanced gynecological malignancies will be enrolled.
PLX2853: PLX2853 tablets
|
PLX2853 + Carboplatin Phase 1b/2a Combination Therapy
n=23 participants at risk
Phase 1b (PLX2853 + carboplatin combination): Up to 15 evaluable subjects with platinum-resistant EOC will be enrolled.
Phase 2a (PLX2853 + carboplatin combination): Up to 26 evaluable subjects with platinum-resistant EOC will be enrolled.
PLX2853: PLX2853 tablets
Carboplatin: Carboplatin IV injection, 5 mg•min/mL
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
14.3%
2/14 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
13.0%
3/23 • Number of events 3 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
35.7%
5/14 • Number of events 5 • Through 30 days after last dose of study drug, an average of 6 months
|
34.8%
8/23 • Number of events 8 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
2/14 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
17.4%
4/23 • Number of events 4 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
42.9%
6/14 • Number of events 6 • Through 30 days after last dose of study drug, an average of 6 months
|
26.1%
6/23 • Number of events 6 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
2/14 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
0.00%
0/23 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
2/14 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
17.4%
4/23 • Number of events 4 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
17.4%
4/23 • Number of events 4 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Investigations
Bilirubin increased
|
21.4%
3/14 • Number of events 3 • Through 30 days after last dose of study drug, an average of 6 months
|
8.7%
2/23 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
30.4%
7/23 • Number of events 7 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
13.0%
3/23 • Number of events 3 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
2/14 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
30.4%
7/23 • Number of events 7 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
21.7%
5/23 • Number of events 5 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
4/14 • Number of events 4 • Through 30 days after last dose of study drug, an average of 6 months
|
30.4%
7/23 • Number of events 7 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
17.4%
4/23 • Number of events 4 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Nervous system disorders
Dysgeusia
|
14.3%
2/14 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
13.0%
3/23 • Number of events 3 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
2/14 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
26.1%
6/23 • Number of events 6 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
21.4%
3/14 • Number of events 3 • Through 30 days after last dose of study drug, an average of 6 months
|
13.0%
3/23 • Number of events 3 • Through 30 days after last dose of study drug, an average of 6 months
|
|
General disorders
Fatigue
|
50.0%
7/14 • Number of events 7 • Through 30 days after last dose of study drug, an average of 6 months
|
56.5%
13/23 • Number of events 13 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Gastrointestinal disorders
Flatulence
|
14.3%
2/14 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
0.00%
0/23 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Gastrointestinal disorders
Gastroesophageal reflex disease
|
21.4%
3/14 • Number of events 3 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Renal and urinary disorders
Hematuria
|
14.3%
2/14 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
0.00%
0/23 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
21.7%
5/23 • Number of events 5 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.6%
4/14 • Number of events 4 • Through 30 days after last dose of study drug, an average of 6 months
|
17.4%
4/23 • Number of events 4 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
26.1%
6/23 • Number of events 6 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
2/14 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
21.7%
5/23 • Number of events 5 • Through 30 days after last dose of study drug, an average of 6 months
|
|
General disorders
Influenza like illness
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
8.7%
2/23 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
13.0%
3/23 • Number of events 3 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Investigations
Lymphocyte count decreased
|
14.3%
2/14 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
8.7%
2/23 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Gastrointestinal disorders
Nausea
|
78.6%
11/14 • Number of events 11 • Through 30 days after last dose of study drug, an average of 6 months
|
78.3%
18/23 • Number of events 18 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
17.4%
4/23 • Number of events 4 • Through 30 days after last dose of study drug, an average of 6 months
|
|
General disorders
Edema
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
8.7%
2/23 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
8.7%
2/23 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Investigations
Platelet count decreased
|
28.6%
4/14 • Number of events 4 • Through 30 days after last dose of study drug, an average of 6 months
|
69.6%
16/23 • Number of events 16 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Renal and urinary disorders
Proteinuria
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
13.0%
3/23 • Number of events 3 • Through 30 days after last dose of study drug, an average of 6 months
|
|
General disorders
Pyrexia
|
21.4%
3/14 • Number of events 3 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
17.4%
4/23 • Number of events 4 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
6/14 • Number of events 6 • Through 30 days after last dose of study drug, an average of 6 months
|
43.5%
10/23 • Number of events 10 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Investigations
Weight loss
|
14.3%
2/14 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
17.4%
4/23 • Number of events 4 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Investigations
Decreased white blood cell
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
21.7%
5/23 • Number of events 5 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
8.7%
2/23 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
8.7%
2/23 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
8.7%
2/23 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Gastrointestinal disorders
Ascites
|
14.3%
2/14 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
8.7%
2/23 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
8.7%
2/23 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
8.7%
2/23 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
8.7%
2/23 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
8.7%
2/23 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/14 • Through 30 days after last dose of study drug, an average of 6 months
|
8.7%
2/23 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Eye disorders
Vision blurred
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
8.7%
2/23 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Infections and infestations
Cystitis
|
14.3%
2/14 • Number of events 2 • Through 30 days after last dose of study drug, an average of 6 months
|
0.00%
0/23 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Gastrointestinal disorders
Eructation
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Investigations
Activated patrial thromboplastin time prolonged
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway cough
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneform
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
4.3%
1/23 • Number of events 1 • Through 30 days after last dose of study drug, an average of 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER