Trial Outcomes & Findings for Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working (NCT NCT05432791)
NCT ID: NCT05432791
Last Updated: 2026-05-12
Results Overview
Will be estimated using the Kaplan-Meier method, where the stratified log-rank test will be used to compare the distributions across the treatment arms. PFS rates at 1 year will also be reported, along with 95% confidence intervals. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be assessed as well.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2/PHASE3
Target enrollment
74 participants
Primary outcome timeframe
Time between the date of randomization and the earliest of disease progression or death, assessed up to 1 year
Results posted on
2026-05-12
Participant Flow
Participant milestones
| Measure |
Arm 1 (Olaparib, Temozolomide)
Patients receive temozolomide PO QD on days 1-7 of each cycle and olaparib PO BID on days 1-7 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and/or bone scans throughout the trial. Patients also undergo collection of blood samples throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood samples
\>
\> Bone Scan: Undergo bone scan
\>
\> Computed Tomography: Undergo CT scan
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Multigated Acquisition Scan: Undergo MUGA
\>
\> Olaparib: Given PO
\>
\> Temozolomide: Given PO
\>
\> Transthoracic Echocardiography Test: Undergo TTE
|
Arm 2 (Trabectedin, Pazopanib)
Patients receive trabectedin IV continuously over 24 hours on day 1 of each cycle or pazopanib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and/or bone scans throughout the trial. Patients also undergo TTE or MUGA on study and as clinically indicated, as well as collection of blood samples throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood samples
\>
\> Bone Scan: Undergo bone scan
\>
\> Computed Tomography: Undergo CT scan
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Multigated Acquisition Scan: Undergo MUGA
\>
\> Pazopanib: Given PO
\>
\> Trabectedin: Given IV
\>
\> Transthoracic Echocardiography Test: Undergo TTE
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
37
|
|
Overall Study
COMPLETED
|
37
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arm 1 (Olaparib, Temozolomide)
Patients receive temozolomide PO QD on days 1-7 of each cycle and olaparib PO BID on days 1-7 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and/or bone scans throughout the trial. Patients also undergo collection of blood samples throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood samples
\>
\> Bone Scan: Undergo bone scan
\>
\> Computed Tomography: Undergo CT scan
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Multigated Acquisition Scan: Undergo MUGA
\>
\> Olaparib: Given PO
\>
\> Temozolomide: Given PO
\>
\> Transthoracic Echocardiography Test: Undergo TTE
|
Arm 2 (Trabectedin, Pazopanib)
Patients receive trabectedin IV continuously over 24 hours on day 1 of each cycle or pazopanib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and/or bone scans throughout the trial. Patients also undergo TTE or MUGA on study and as clinically indicated, as well as collection of blood samples throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood samples
\>
\> Bone Scan: Undergo bone scan
\>
\> Computed Tomography: Undergo CT scan
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Multigated Acquisition Scan: Undergo MUGA
\>
\> Pazopanib: Given PO
\>
\> Trabectedin: Given IV
\>
\> Transthoracic Echocardiography Test: Undergo TTE
|
|---|---|---|
|
Overall Study
Still on Treatment
|
0
|
1
|
Baseline Characteristics
Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working
Baseline characteristics by cohort
| Measure |
Arm 1 (Olaparib, Temozolomide)
n=37 Participants
Patients receive temozolomide PO QD on days 1-7 of each cycle and olaparib PO BID on days 1-7 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and/or bone scans throughout the trial. Patients also undergo collection of blood samples throughout the trial.\> \> Biospecimen Collection: Undergo collection of blood samples\>
\> Bone Scan: Undergo bone scan\>
\> Computed Tomography: Undergo CT scan\>
\> Magnetic Resonance Imaging: Undergo MRI\>
\> Multigated Acquisition Scan: Undergo MUGA\>
\> Olaparib: Given PO\>
\> Temozolomide: Given PO\>
\> Transthoracic Echocardiography Test: Undergo TTE
|
Arm 2 (Trabectedin, Pazopanib)
n=37 Participants
Patients receive trabectedin IV continuously over 24 hours on day 1 of each cycle or pazopanib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and/or bone scans throughout the trial. Patients also undergo TTE or MUGA on study and as clinically indicated, as well as collection of blood samples throughout the trial.\> \> Biospecimen Collection: Undergo collection of blood samples\>
\> Bone Scan: Undergo bone scan\>
\> Computed Tomography: Undergo CT scan\>
\> Magnetic Resonance Imaging: Undergo MRI\>
\> Multigated Acquisition Scan: Undergo MUGA\>
\> Pazopanib: Given PO\>
\> Trabectedin: Given IV\>
\> Transthoracic Echocardiography Test: Undergo TTE
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=1512 Participants
|
5 Participants
n=504 Participants
|
11 Participants
n=2016 Participants
|
|
Age, Continuous
|
58.0 years
n=1512 Participants
|
58.0 years
n=504 Participants
|
58.0 years
n=2016 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=1512 Participants
|
37 Participants
n=504 Participants
|
74 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=1512 Participants
|
30 Participants
n=504 Participants
|
59 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
4 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=1512 Participants
|
6 Participants
n=504 Participants
|
17 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=1512 Participants
|
25 Participants
n=504 Participants
|
44 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=1512 Participants
|
4 Participants
n=504 Participants
|
11 Participants
n=2016 Participants
|
|
ECOG PS (0 or 1)
|
37 Participants
n=1512 Participants
|
37 Participants
n=504 Participants
|
74 Participants
n=2016 Participants
|
|
Prior Lines of Treatment
2
|
22 Participants
n=1512 Participants
|
22 Participants
n=504 Participants
|
44 Participants
n=2016 Participants
|
|
Prior Lines of Treatment
3 or more
|
15 Participants
n=1512 Participants
|
15 Participants
n=504 Participants
|
30 Participants
n=2016 Participants
|
PRIMARY outcome
Timeframe: Time between the date of randomization and the earliest of disease progression or death, assessed up to 1 yearWill be estimated using the Kaplan-Meier method, where the stratified log-rank test will be used to compare the distributions across the treatment arms. PFS rates at 1 year will also be reported, along with 95% confidence intervals. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be assessed as well.
Outcome measures
| Measure |
Arm 1 (Olaparib, Temozolomide)
n=34 Participants
Patients receive temozolomide PO QD on days 1-7 of each cycle and olaparib PO BID on days 1-7 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and/or bone scans throughout the trial. Patients also undergo collection of blood samples throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood samples
\>
\> Bone Scan: Undergo bone scan
\>
\> Computed Tomography: Undergo CT scan
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Multigated Acquisition Scan: Undergo MUGA
\>
\> Olaparib: Given PO
\>
\> Temozolomide: Given PO
\>
\> Transthoracic Echocardiography Test: Undergo TTE
|
Arm 2 (Trabectedin, Pazopanib)
n=36 Participants
Patients receive trabectedin IV continuously over 24 hours on day 1 of each cycle or pazopanib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and/or bone scans throughout the trial. Patients also undergo TTE or MUGA on study and as clinically indicated, as well as collection of blood samples throughout the trial.
\>
\> Biospecimen Collection: Undergo collection of blood samples
\>
\> Bone Scan: Undergo bone scan
\>
\> Computed Tomography: Undergo CT scan
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Multigated Acquisition Scan: Undergo MUGA
\>
\> Pazopanib: Given PO
\>
\> Trabectedin: Given IV
\>
\> Transthoracic Echocardiography Test: Undergo TTE
|
|---|---|---|
|
Progression Free Survival (PFS) (Phase II)
|
3.2 Months
Interval 2.0 to
Not enough events to calculate upper bound
|
5.6 Months
Interval 2.8 to
Not enough events to calculate upper bound
|
PRIMARY outcome
Timeframe: Time between the date of randomization and the date of death from any cause, assessed up to 5 yearsPopulation: The trial failed to pass the Phase II threshold to move to Phase III as noted in the DSMB recommendation. Any Phase III portion will not be analyzed.
Will be estimated using the Kaplan-Meier method, where the stratified log-rank test will be used to compare the distributions across the treatment arms. OS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be assessed as well.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsWill be estimated by dividing the number of evaluable patients that achieve a confirmed response (partial response \[PR\] or better) by the total number of evaluable patients. This estimate will be calculated by arm and will also include a 95% confidence interval using the properties of the binomial distribution, and compared between the arms using a chi-square test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from first evidence of response until disease progression (or death), assessed up to 5 yearsThis analysis is restricted to those patients that achieved a confirmed response (PR or better). Patients that go off of study treatment prior to progression will have their DOR time censored at that time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 weeksWill be estimated using the number of patients that achieve complete response, partial response, or stable disease at the 6 week assessment divided by all evaluable patients. This estimate will be calculated by arm and will also include a 95% confidence interval using the properties of the binomial distribution, and compared between the arms using a chi-square test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 weeks after the end of study treatmentAdverse events will be recorded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for each patient. Frequency tables and summary statistics will be used and with the appropriate methods of evaluating categorical and continuous data. In addition, patient reported safety and tolerability will be assessed using Patient-Reported Outcomes (PRO)-CTCAE for a prespecified group of expected toxicities. PRO-CTCAE assessments will occur prior to registration and on day 1 of every cycle during treatment. Collection of PRO-CTCAE will be discontinued after cycle 11.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 (Olaparib, Temozolomide)
Serious events: 8 serious events
Other events: 36 other events
Deaths: 6 deaths
Arm 2 (Trabectedin, Pazopanib)
Serious events: 13 serious events
Other events: 29 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Arm 1 (Olaparib, Temozolomide)
n=37 participants at risk
Transthoracic Echocardiography Test: Undergo TTE
|
Arm 2 (Trabectedin, Pazopanib)
n=37 participants at risk
Transthoracic Echocardiography Test: Undergo TTE
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.8%
4/37 • Number of events 5 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/37 • Up to 1 year
|
8.1%
3/37 • Number of events 3 • Up to 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Nausea
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
General disorders
Fatigue
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
General disorders
Fever
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
General disorders
Pain
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/37 • Up to 1 year
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Investigations
Neutrophil count decreased
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Investigations
Platelet count decreased
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Investigations
White blood cell decreased
|
8.1%
3/37 • Number of events 3 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Dizziness
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Nervous system disorders
Spinal cord compression
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
Other adverse events
| Measure |
Arm 1 (Olaparib, Temozolomide)
n=37 participants at risk
Transthoracic Echocardiography Test: Undergo TTE
|
Arm 2 (Trabectedin, Pazopanib)
n=37 participants at risk
Transthoracic Echocardiography Test: Undergo TTE
|
|---|---|---|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
3/37 • Number of events 5 • Up to 1 year
|
10.8%
4/37 • Number of events 5 • Up to 1 year
|
|
General disorders
Edema limbs
|
5.4%
2/37 • Number of events 3 • Up to 1 year
|
8.1%
3/37 • Number of events 6 • Up to 1 year
|
|
General disorders
Fatigue
|
78.4%
29/37 • Number of events 98 • Up to 1 year
|
62.2%
23/37 • Number of events 95 • Up to 1 year
|
|
General disorders
Localized edema
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
General disorders
Non-cardiac chest pain
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
General disorders
Pain
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Infections and infestations
Bladder infection
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Infections and infestations
Infections and infestations - Oth spec
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Infections and infestations
Sepsis
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Thrush
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
|
Infections and infestations
Urinary tract infection
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Bruising
|
8.1%
3/37 • Number of events 4 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
0.00%
0/37 • Up to 1 year
|
5.4%
2/37 • Number of events 5 • Up to 1 year
|
|
Investigations
Alanine aminotransferase increased
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
16.2%
6/37 • Number of events 26 • Up to 1 year
|
|
Investigations
Alkaline phosphatase increased
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
16.2%
6/37 • Number of events 30 • Up to 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
21.6%
8/37 • Number of events 20 • Up to 1 year
|
|
Investigations
CPK increased
|
0.00%
0/37 • Up to 1 year
|
5.4%
2/37 • Number of events 5 • Up to 1 year
|
|
Investigations
Creatinine increased
|
5.4%
2/37 • Number of events 3 • Up to 1 year
|
8.1%
3/37 • Number of events 5 • Up to 1 year
|
|
Investigations
Investigations - Other, specify
|
2.7%
1/37 • Number of events 3 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
|
Investigations
Lymphocyte count decreased
|
18.9%
7/37 • Number of events 20 • Up to 1 year
|
13.5%
5/37 • Number of events 23 • Up to 1 year
|
|
Investigations
Neutrophil count decreased
|
70.3%
26/37 • Number of events 66 • Up to 1 year
|
13.5%
5/37 • Number of events 23 • Up to 1 year
|
|
Investigations
Platelet count decreased
|
48.6%
18/37 • Number of events 53 • Up to 1 year
|
24.3%
9/37 • Number of events 20 • Up to 1 year
|
|
Investigations
Thyroid stimulating hormone increased
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Investigations
Weight gain
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Investigations
Weight loss
|
2.7%
1/37 • Number of events 8 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Investigations
White blood cell decreased
|
67.6%
25/37 • Number of events 70 • Up to 1 year
|
21.6%
8/37 • Number of events 32 • Up to 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
13.5%
5/37 • Number of events 11 • Up to 1 year
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.1%
3/37 • Number of events 9 • Up to 1 year
|
8.1%
3/37 • Number of events 6 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/37 • Up to 1 year
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.4%
2/37 • Number of events 3 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
5.4%
2/37 • Number of events 3 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.8%
4/37 • Number of events 15 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.9%
7/37 • Number of events 9 • Up to 1 year
|
5.4%
2/37 • Number of events 5 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 6 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 3 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.7%
1/37 • Number of events 9 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 3 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
2/37 • Number of events 4 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Nervous system disorders
Dizziness
|
2.7%
1/37 • Number of events 6 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Nervous system disorders
Dysgeusia
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
5.4%
2/37 • Number of events 13 • Up to 1 year
|
|
Nervous system disorders
Headache
|
13.5%
5/37 • Number of events 20 • Up to 1 year
|
5.4%
2/37 • Number of events 3 • Up to 1 year
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/37 • Up to 1 year
|
5.4%
2/37 • Number of events 6 • Up to 1 year
|
|
Psychiatric disorders
Anxiety
|
8.1%
3/37 • Number of events 5 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Psychiatric disorders
Depression
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Psychiatric disorders
Insomnia
|
2.7%
1/37 • Number of events 3 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Renal and urinary disorders
Bladder spasm
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
5.4%
2/37 • Number of events 4 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Renal and urinary disorders
Glucosuria
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
2.7%
1/37 • Number of events 3 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
5.4%
2/37 • Number of events 3 • Up to 1 year
|
|
Reproductive system and breast disorders
Vaginal discharge
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
2.7%
1/37 • Number of events 6 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.1%
3/37 • Number of events 4 • Up to 1 year
|
8.1%
3/37 • Number of events 19 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.1%
3/37 • Number of events 5 • Up to 1 year
|
8.1%
3/37 • Number of events 4 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.8%
4/37 • Number of events 4 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
10.8%
4/37 • Number of events 8 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Hair color changes
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 3 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 3 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 3 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.7%
1/37 • Number of events 3 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 3 • Up to 1 year
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
|
Vascular disorders
Flushing
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Vascular disorders
Hot flashes
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Vascular disorders
Hypertension
|
13.5%
5/37 • Number of events 12 • Up to 1 year
|
13.5%
5/37 • Number of events 16 • Up to 1 year
|
|
Vascular disorders
Thromboembolic event
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
|
Gastrointestinal disorders
Abdominal distension
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
16.2%
6/37 • Number of events 12 • Up to 1 year
|
16.2%
6/37 • Number of events 11 • Up to 1 year
|
|
Gastrointestinal disorders
Bloating
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Gastrointestinal disorders
Constipation
|
27.0%
10/37 • Number of events 19 • Up to 1 year
|
21.6%
8/37 • Number of events 15 • Up to 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
37.8%
14/37 • Number of events 27 • Up to 1 year
|
24.3%
9/37 • Number of events 41 • Up to 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
5.4%
2/37 • Number of events 3 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Gastrointestinal disorders
Esophageal pain
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 3 • Up to 1 year
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.7%
1/37 • Number of events 3 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
8.1%
3/37 • Number of events 4 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
|
Gastrointestinal disorders
Nausea
|
56.8%
21/37 • Number of events 63 • Up to 1 year
|
45.9%
17/37 • Number of events 55 • Up to 1 year
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/37 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
67.6%
25/37 • Number of events 80 • Up to 1 year
|
37.8%
14/37 • Number of events 64 • Up to 1 year
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
|
Cardiac disorders
Palpitations
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
2.7%
1/37 • Number of events 3 • Up to 1 year
|
|
Eye disorders
Blurred vision
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Eye disorders
Cataract
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Eye disorders
Dry eye
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
|
Eye disorders
Eye disorders - Other, specify
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
2.7%
1/37 • Number of events 3 • Up to 1 year
|
|
Eye disorders
Eye pain
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
Additional Information
Dr. Matthew Ingham
Perlmutter Cancer Center NYU Langone Health
Phone: 202-285-4944
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60