Trial Outcomes & Findings for Pembrolizumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NCT NCT02520154)
NCT ID: NCT02520154
Last Updated: 2025-06-08
Results Overview
PFS was defined from the start of neoadjuvant therapy until the date of disease progression or death, whichever occurred first. Disease progression was evaluated using RECIST v1.1 guidelines. Patients who were alive without disease progression were censored at their last evaluation date or until withdrawal of consent. Patients who were removed off protocol for reasons other than disease progression, death, treatment toxicity, or withdrawal of consent were censored at the start date of their non-protocol treatment. Feasibility was defined as the ability to complete all planned 3 cycles of adjuvant carboplatin, paclitaxel, and pembrolizumab.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2025-06-08
Participant Flow
The study was activated on 07/05/2016 and closed to new patient entry on 09/09/2020. All recruitments were done in a medical clinic setting
There were 58 participants who were screened for the protocol study. 27 participants were found to be screen failures, 2 participants withdrew from the study, 2 participants were taken off study due to medical concerns by their primary physician, and 1 participants expired from early progression of disease not related to the study treatment. 26 participants were able to complete the study treatments as outlined in the study design
Participant milestones
| Measure |
Treatment Group
Paclitaxel 80 mg/m2 IV on Day 1, 8, 15 + Carboplatin AUC of 6 IV on Day 1 for 3 cycles every 21 days, followed by interval debulking surgery, then followed by Pembrolizumab 200 mg IV on Day 1 + Paclitaxel 80 mg/m2 IV on Day 1, 8, 15 + Carboplatin AUC of 6 IV on Day 1 for 3 cycles every 21 days, followed by Pembrolizumab maintenance at 200 mg IV every 21 days for up to 20 additional cycles
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment Group
Paclitaxel 80 mg/m2 IV on Day 1, 8, 15 + Carboplatin AUC of 6 IV on Day 1 for 3 cycles every 21 days, followed by interval debulking surgery, then followed by Pembrolizumab 200 mg IV on Day 1 + Paclitaxel 80 mg/m2 IV on Day 1, 8, 15 + Carboplatin AUC of 6 IV on Day 1 for 3 cycles every 21 days, followed by Pembrolizumab maintenance at 200 mg IV every 21 days for up to 20 additional cycles
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Pembrolizumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
Treatment Group
n=31 Participants
Paclitaxel 80 mg/m2 IV on Day 1, 8, 15 + Carboplatin AUC of 6 IV on Day 1 for 3 cycles every 21 days, followed by interval debulking surgery, then followed by Pembrolizumab 200 mg IV on Day 1 + Paclitaxel 80 mg/m2 IV on Day 1, 8, 15 + Carboplatin AUC of 6 IV on Day 1 for 3 cycles every 21 days, followed by Pembrolizumab maintenance at 200 mg IV every 21 days for up to 20 additional cycles
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
|
Treatment Group
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPFS was defined from the start of neoadjuvant therapy until the date of disease progression or death, whichever occurred first. Disease progression was evaluated using RECIST v1.1 guidelines. Patients who were alive without disease progression were censored at their last evaluation date or until withdrawal of consent. Patients who were removed off protocol for reasons other than disease progression, death, treatment toxicity, or withdrawal of consent were censored at the start date of their non-protocol treatment. Feasibility was defined as the ability to complete all planned 3 cycles of adjuvant carboplatin, paclitaxel, and pembrolizumab.
Outcome measures
| Measure |
Treatment Group
n=31 Participants
Paclitaxel 80 mg/m2 IV on Day 1, 8, 15 + Carboplatin AUC of 6 IV on Day 1 for 3 cycles every 21 days, followed by interval debulking surgery, then followed by Pembrolizumab 200 mg IV on Day 1 + Paclitaxel 80 mg/m2 IV on Day 1, 8, 15 + Carboplatin AUC of 6 IV on Day 1 for 3 cycles every 21 days, followed by Pembrolizumab maintenance at 200 mg IV every 21 days for up to 20 additional cycles
|
|---|---|
|
To Evaluate Progression-free Survival of Paclitaxel/Carboplatin and Pembrolizumab in Patients With Advanced Stage, Metastatic Ovarian Cancer Undergoing NACT
|
14.2 months
Interval 10.5 to 23.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsPembrolizumab with chemotherapy was feasible and resulted in PFS within the historical range for this EOC population.
Outcome measures
| Measure |
Treatment Group
n=31 Participants
Paclitaxel 80 mg/m2 IV on Day 1, 8, 15 + Carboplatin AUC of 6 IV on Day 1 for 3 cycles every 21 days, followed by interval debulking surgery, then followed by Pembrolizumab 200 mg IV on Day 1 + Paclitaxel 80 mg/m2 IV on Day 1, 8, 15 + Carboplatin AUC of 6 IV on Day 1 for 3 cycles every 21 days, followed by Pembrolizumab maintenance at 200 mg IV every 21 days for up to 20 additional cycles
|
|---|---|
|
To Describe the Feasibility of Combination Therapy and Maintenance Pembrolizumab in This Population
|
26 Participants
|
SECONDARY outcome
Timeframe: up to 3 yearsToxicity was evaluated via grading and recording treatment-related adverse events (TRAE) according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
Outcome measures
| Measure |
Treatment Group
n=31 Participants
Paclitaxel 80 mg/m2 IV on Day 1, 8, 15 + Carboplatin AUC of 6 IV on Day 1 for 3 cycles every 21 days, followed by interval debulking surgery, then followed by Pembrolizumab 200 mg IV on Day 1 + Paclitaxel 80 mg/m2 IV on Day 1, 8, 15 + Carboplatin AUC of 6 IV on Day 1 for 3 cycles every 21 days, followed by Pembrolizumab maintenance at 200 mg IV every 21 days for up to 20 additional cycles
|
|---|---|
|
To Evaluate the Safety of Combination and Maintenance Pembrolizumab
|
31 Participants
|
Adverse Events
Treatment Group
Serious events: 13 serious events
Other events: 26 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment Group
n=31 participants at risk
Paclitaxel 80 mg/m2 IV on Day 1, 8, 15 + Carboplatin AUC of 6 IV on Day 1 for 3 cycles every 21 days, followed by interval debulking surgery, then followed by Pembrolizumab 200 mg IV on Day 1 + Paclitaxel 80 mg/m2 IV on Day 1, 8, 15 + Carboplatin AUC of 6 IV on Day 1 for 3 cycles every 21 days, followed by Pembrolizumab maintenance at 200 mg IV every 21 days for up to 20 additional cycles
|
|---|---|
|
Investigations
Neutrophil count decrease
|
16.1%
5/31 • Number of events 6 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Endocrine disorders
Adrenal insufficiency
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Investigations
SGPT increased
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Investigations
SGOT increased
|
3.2%
1/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Blood and lymphatic system disorders
Anemia
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Investigations
Lipid increased
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Investigations
Platelet count decreased
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Vascular disorders
Thromboembolic event
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
Other adverse events
| Measure |
Treatment Group
n=31 participants at risk
Paclitaxel 80 mg/m2 IV on Day 1, 8, 15 + Carboplatin AUC of 6 IV on Day 1 for 3 cycles every 21 days, followed by interval debulking surgery, then followed by Pembrolizumab 200 mg IV on Day 1 + Paclitaxel 80 mg/m2 IV on Day 1, 8, 15 + Carboplatin AUC of 6 IV on Day 1 for 3 cycles every 21 days, followed by Pembrolizumab maintenance at 200 mg IV every 21 days for up to 20 additional cycles
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
9.7%
3/31 • Number of events 3 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Endocrine disorders
Adrenal insufficiency
|
6.5%
2/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Investigations
SGPT increased
|
29.0%
9/31 • Number of events 19 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Investigations
Alk Phos increased
|
12.9%
4/31 • Number of events 6 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.5%
2/31 • Number of events 3 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Blood and lymphatic system disorders
Anemia
|
83.9%
26/31 • Number of events 92 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.9%
4/31 • Number of events 7 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
32.3%
10/31 • Number of events 16 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Investigations
SGOT increased
|
25.8%
8/31 • Number of events 22 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
2/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Gastrointestinal disorders
Bloating
|
3.2%
1/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Blood and lymphatic system disorders
MCV decreased
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Blood and lymphatic system disorders
Enlarged lymph node
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Investigations
Blood bilirubin increased
|
6.5%
2/31 • Number of events 3 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.7%
3/31 • Number of events 4 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
General disorders
Conjunctivitis
|
6.5%
2/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Gastrointestinal disorders
Constipation
|
12.9%
4/31 • Number of events 5 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Investigations
Creatinine increased
|
6.5%
2/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Gastrointestinal disorders
Diarrhea
|
19.4%
6/31 • Number of events 11 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Nervous system disorders
Dizziness
|
6.5%
2/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Gastrointestinal disorders
Dry mouth
|
6.5%
2/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Nervous system disorders
Dysgeusia
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
2/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.1%
5/31 • Number of events 5 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
General disorders
Edema limbs
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
General disorders
T3 level decreased
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
General disorders
T4 level decreased
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
General disorders
TSH level decreased
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Gastrointestinal disorders
Enterocolitis
|
3.2%
1/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.1%
5/31 • Number of events 5 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
General disorders
Fatigue
|
25.8%
8/31 • Number of events 14 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
General disorders
Fever
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Vascular disorders
Flushing
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
9.7%
3/31 • Number of events 4 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Nervous system disorders
Headache
|
16.1%
5/31 • Number of events 5 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.7%
3/31 • Number of events 4 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.5%
2/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.5%
2/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
General disorders
Hyperthyroidism
|
12.9%
4/31 • Number of events 5 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
6.5%
2/31 • Number of events 3 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.6%
7/31 • Number of events 11 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
54.8%
17/31 • Number of events 33 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.5%
2/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.5%
2/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Vascular disorders
Hypotension
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
General disorders
Hypothyroidism
|
16.1%
5/31 • Number of events 5 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
General disorders
Insomnia
|
6.5%
2/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Investigations
Lipase increased
|
12.9%
4/31 • Number of events 15 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
General disorders
Localized edema
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Metabolism and nutrition disorders
Increased phosphorus
|
9.7%
3/31 • Number of events 6 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Metabolism and nutrition disorders
LDH increased
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Metabolism and nutrition disorders
Chloride decreased
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Gastrointestinal disorders
Mucositis oral
|
9.7%
3/31 • Number of events 4 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Gastrointestinal disorders
Nausea
|
35.5%
11/31 • Number of events 14 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
General disorders
Neck edema
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Investigations
Neutrophil count decreased
|
77.4%
24/31 • Number of events 99 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Nervous system disorders
Nystagmus
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Gastrointestinal disorders
Oral pain
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
General disorders
Pain
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Cardiac disorders
Palpitations
|
6.5%
2/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.8%
8/31 • Number of events 11 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Vascular disorders
Phlebitis
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Investigations
Platelet count decreased
|
45.2%
14/31 • Number of events 45 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Nervous system disorders
Presyncope
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Renal and urinary disorders
Proteinuria
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.4%
6/31 • Number of events 6 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.5%
2/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
29.0%
9/31 • Number of events 9 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Renal and urinary disorders
Increased BUN
|
6.5%
2/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Renal and urinary disorders
Increased leukocytes in urine
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucositis
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Investigations
Serum amylase increased
|
16.1%
5/31 • Number of events 8 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Cardiac disorders
Sinus bradycardia
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Cardiac disorders
Sinus tachycardia
|
6.5%
2/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
General disorders
Tinnitus
|
6.5%
2/31 • Number of events 2 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Nervous system disorders
Tremor
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Infections and infestations
Upper respiratory infection
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
General disorders
Vaginal dryness
|
3.2%
1/31 • Number of events 1 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
4/31 • Number of events 5 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
|
Investigations
White blood count decreased
|
80.6%
25/31 • Number of events 99 • Up to 3 years
The study was activated on 05/16/2016 and the first patient was registered on study 09/02/2016. The last patient treated on study was taken off treatment on 05/28/2021. Adverse events were reported from baseline till 30 days following the last dose of study agent given.
|
Additional Information
Dr. Amir Jazaeri MD
University of Texas M D Anderson Cancer Center
Phone: (713) 745-1613
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place