Trial Outcomes & Findings for Enzastaurin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer (NCT NCT00407758)
NCT ID: NCT00407758
Last Updated: 2019-03-20
Results Overview
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
CT scan or MRI if used to follow lesions for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.
Results posted on
2019-03-20
Participant Flow
This trial was opened to patient entry on November 6, 2006 and was closed to accrual on May 7, 2007.
Participant milestones
| Measure |
Enzastaurin
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Enzastaurin
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
|
|---|---|
|
Overall Study
ineligible -improper prior treatment
|
1
|
Baseline Characteristics
Enzastaurin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Enzastaurin
n=27 Participants
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
|
|---|---|
|
Age, Customized
40-49 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
10 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
6 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: CT scan or MRI if used to follow lesions for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.Population: Eligible and treated patients
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above.
Outcome measures
| Measure |
Enzastaurin
n=27 Participants
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
|
|---|---|
|
Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Partial response
|
2 Participants
|
|
Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Complete response
|
0 Participants
|
PRIMARY outcome
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years.Population: Eligible and treated patients
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Enzastaurin
n=27 Participants
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
|
|---|---|
|
Progression-free Survival > 6 Months Using RECIST 1.0
PFS> 6 months - Yes
|
3 Participants
|
|
Progression-free Survival > 6 Months Using RECIST 1.0
PFS>6months - No
|
24 Participants
|
PRIMARY outcome
Timeframe: Assessed every cycle while on treatment, 30 days after the last cycle of treatmentPopulation: Eligible and treated patients
Number of participants with a maximum grade of 3 or higher during the treatment period.
Outcome measures
| Measure |
Enzastaurin
n=27 Participants
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
|
|---|---|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Anemia
|
1 Participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Constitutional
|
5 Participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Gastrointestinal
|
11 Participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Infection
|
2 Participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Metabolic
|
4 Participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Other Neurological
|
1 Participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Pain
|
5 Participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Pulmonary
|
5 Participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Vascular
|
1 Participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Death, not CTC coded
|
3 Participants
|
SECONDARY outcome
Timeframe: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.Population: Eligible and treated patients
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Outcome measures
| Measure |
Enzastaurin
n=27 Participants
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
|
|---|---|
|
Duration Overall Survival
|
15.1 months
Interval 6.5 to
Upper limit not yet reached
|
SECONDARY outcome
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years.Population: Eligible and treated patients
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Enzastaurin
n=27 Participants
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
|
|---|---|
|
Duration of Progression-free Survival (PFS)
|
1.8 months
Interval 1.5 to 2.7
|
SECONDARY outcome
Timeframe: BaselinePopulation: Eligible and treated patients
Platinum sensitive = a platinum-free interval between 6 and 12 months.
Outcome measures
| Measure |
Enzastaurin
n=27 Participants
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
|
|---|---|
|
Prognostic Factor - Number of Patients With Platinum Sensitivity
Platinum Sensitive
|
11 Participants
|
|
Prognostic Factor - Number of Patients With Platinum Sensitivity
Not Platinum Sensitive
|
16 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Eligible and treated patients
Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work
Outcome measures
| Measure |
Enzastaurin
n=27 Participants
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
|
|---|---|
|
Prognostic Factor - Initial Performance Status
Performance Status = 0
|
16 Participants
|
|
Prognostic Factor - Initial Performance Status
Performance Status = 1
|
11 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Eligible and treated patients
Outcome measures
| Measure |
Enzastaurin
n=27 Participants
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
|
|---|---|
|
Prognostic Factor - Age at Study Entry
|
59 years
Interval 53.0 to 71.0
|
Adverse Events
Enzastaurin
Serious events: 12 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enzastaurin
n=27 participants at risk
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
|
|---|---|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
11.1%
3/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Obstruction, Gi - Rectum
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Obstruction, Gi - Colon
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Ascites
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Dehydration
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Constipation
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Abdominal Pain Nos
|
7.4%
2/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
Other adverse events
| Measure |
Enzastaurin
n=27 participants at risk
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
|
|---|---|
|
Immune system disorders
Rhinitis
|
14.8%
4/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Neutrophils
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Platelets
|
11.1%
3/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Leukocytes
|
11.1%
3/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Hemoglobin
|
70.4%
19/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Palpitations
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Hypertension
|
7.4%
2/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Sweating
|
7.4%
2/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Weight Gain
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Fever
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Weight Loss
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Fatigue
|
74.1%
20/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Insomnia
|
14.8%
4/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
7.4%
2/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
3/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.4%
2/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Decubitus
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Endocrine disorders
Hot Flashes
|
7.4%
2/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Endocrine disorders
Diabetes
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Obstruction, Gi - Colon
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Heartburn
|
7.4%
2/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Ascites
|
14.8%
4/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Ileus
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Dysphagia
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Distention
|
11.1%
3/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Taste Alteration
|
7.4%
2/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Incontinence, Anal
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Dry Mouth
|
11.1%
3/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
7.4%
2/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
9/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Anorexia
|
44.4%
12/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Dehydration
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Constipation
|
44.4%
12/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Nausea
|
40.7%
11/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Diarrhea
|
48.1%
13/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage, Gi - Upper Gi Nos
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Petechiae
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Pleura
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Blood
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Wound
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Colon
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
18.5%
5/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Vulva
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Edema: Limb
|
29.6%
8/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Blood and lymphatic system disorders
Edema: Head And Neck
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Ast
|
7.4%
2/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Gfr
|
11.1%
3/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Creatinine
|
14.8%
4/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
18.5%
5/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Alt
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
11.1%
3/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.4%
2/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hyponatremia
|
22.2%
6/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
3/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.1%
3/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.8%
4/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
3/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.8%
4/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Mood Alteration - Depression
|
7.4%
2/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
7.4%
2/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Tremor
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Somnolence
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Dizziness
|
7.4%
2/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Neuropathy-Sensory
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Neuropathy-Motor
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Pelvis
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Breast
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Chest /Thorax Nos
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Head/Headache
|
11.1%
3/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Extremity-Limb
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Joint
|
11.1%
3/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Bone
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Rectum
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Abdominal Pain Nos
|
40.7%
11/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Tumor
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain: Muscle
|
11.1%
3/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
2/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
44.4%
12/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Urinary Color Change
|
11.1%
3/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Flu-Like Syndrome
|
3.7%
1/27 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60