Trial Outcomes & Findings for Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies (NCT NCT01554371)
NCT ID: NCT01554371
Last Updated: 2021-02-03
Results Overview
Standard dose-confirmation design of 3 to 6 participants per cohort (3+3 design) was used to determine the MTD of eribulin in combination with cyclophosphamide for participants with any solid tumor. The highest dose level or MTD is reached when no more than one of six participants experience a Dose Limiting Toxicity (DLTs). A DLT is defined as any treatment-related toxicity in first 28 days of therapy with a grade 3 or 4 non-hematologic toxicity, a grade 4 neutropenia or thrombocytopenia lasting \>7 days or febrile neutropenia, or any clinically significant toxicity grade 2 or higher that requires more than 14 days to resolve. The highest dose level at which no more than one of six participants experience DLT defines the MTD.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2021-02-03
Participant Flow
Participant milestones
| Measure |
Phase 1b: 1.1 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.1 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/ m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase 1b: 1.4 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.4 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/ m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)
Dose-expansion cohort will enroll patients with advanced breast cancer only after Phase Ib enrollment has been concluded. The MTD of Eribulin mesylate will be administered on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
38
|
|
Overall Study
COMPLETED
|
3
|
3
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies
Baseline characteristics by cohort
| Measure |
Phase 1b: 1.1 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
n=3 Participants
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.1 mg/m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle. The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase 1b: 1.4 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
n=3 Participants
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.4 mg/m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle. The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)
n=38 Participants
Dose-expansion cohort will enroll patients with advanced breast cancer only after Phase Ib enrollment has been concluded. The MTD of Eribulin mesylate will be administered on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
30-39 years old
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Customized
40-49 years old
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Age, Customized
50-59 years old
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Customized
60-69 years old
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Age, Customized
70-79 years old
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Customized
80-89 years old
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
38 participants
n=5 Participants
|
44 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsStandard dose-confirmation design of 3 to 6 participants per cohort (3+3 design) was used to determine the MTD of eribulin in combination with cyclophosphamide for participants with any solid tumor. The highest dose level or MTD is reached when no more than one of six participants experience a Dose Limiting Toxicity (DLTs). A DLT is defined as any treatment-related toxicity in first 28 days of therapy with a grade 3 or 4 non-hematologic toxicity, a grade 4 neutropenia or thrombocytopenia lasting \>7 days or febrile neutropenia, or any clinically significant toxicity grade 2 or higher that requires more than 14 days to resolve. The highest dose level at which no more than one of six participants experience DLT defines the MTD.
Outcome measures
| Measure |
Phase 1b: Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
n=6 Participants
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.1 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/ m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase 1b: 1.4 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.4 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)
Dose-expansion cohort will enroll patients with advanced breast cancer only after Phase Ib enrollment has been concluded. The MTD of Eribulin mesylate will be administered on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) in Participants With Any Solid Tumor (Phase Ib)
Eribulin
|
1.4 milligrams per square meter (mg/m2)
|
—
|
—
|
|
Maximum Tolerated Dose (MTD) in Participants With Any Solid Tumor (Phase Ib)
Cyclophosphamide
|
600 milligrams per square meter (mg/m2)
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 24 monthsThe clinical benefit rate is defined as the proportion of participants with confirmed complete response (CR), partial response (PR) and stable disease (SD) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Responses are determined by changes in the largest diameter of the tumor lesions and the shortest diameter in the case of malignant lymph nodes. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter, PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters, and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Only participants with measurable disease present at baseline, received at least 1 cycle of therapy, and had disease re-evaluated will be considered evaluable.
Outcome measures
| Measure |
Phase 1b: Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
n=38 Participants
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.1 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/ m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase 1b: 1.4 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.4 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)
Dose-expansion cohort will enroll patients with advanced breast cancer only after Phase Ib enrollment has been concluded. The MTD of Eribulin mesylate will be administered on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
|---|---|---|---|
|
Clinical Benefit Rate for Patients With Advanced Breast Cancer (ABC) (Phase II)
|
.135 proportion of particpants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 monthsSafety of combination of eribulin and cyclophosphamide in participants was assessed by monitoring the frequency of treatment-related toxicities according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 with an attribute of possibly, probably, or definitely related to treatment. Number of participants by toxicity will be reported.
Outcome measures
| Measure |
Phase 1b: Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
n=3 Participants
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.1 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/ m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase 1b: 1.4 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
n=3 Participants
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.4 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)
n=38 Participants
Dose-expansion cohort will enroll patients with advanced breast cancer only after Phase Ib enrollment has been concluded. The MTD of Eribulin mesylate will be administered on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
|---|---|---|---|
|
Number of Participants With Treatment-related Toxicities
White blood cell decreased
|
1 participants
|
2 participants
|
18 participants
|
|
Number of Participants With Treatment-related Toxicities
Mucositis oral
|
1 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Treatment-related Toxicities
Nausea
|
3 participants
|
3 participants
|
19 participants
|
|
Number of Participants With Treatment-related Toxicities
Constipation
|
3 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-related Toxicities
Fatigue
|
1 participants
|
3 participants
|
26 participants
|
|
Number of Participants With Treatment-related Toxicities
Peripheral sensory neuropathy
|
2 participants
|
1 participants
|
15 participants
|
|
Number of Participants With Treatment-related Toxicities
Anorexia
|
1 participants
|
2 participants
|
13 participants
|
|
Number of Participants With Treatment-related Toxicities
Platelet count decreased
|
0 participants
|
2 participants
|
5 participants
|
|
Number of Participants With Treatment-related Toxicities
Alopecia
|
1 participants
|
1 participants
|
9 participants
|
|
Number of Participants With Treatment-related Toxicities
Arthralgia
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Treatment-related Toxicities
Hemoglobin increased
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-related Toxicities
Headache
|
1 participants
|
0 participants
|
4 participants
|
|
Number of Participants With Treatment-related Toxicities
Chills
|
0 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Treatment-related Toxicities
Alanine aminotransferase increased
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-related Toxicities
Rash maculo-papular
|
0 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Treatment-related Toxicities
Epistaxis
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-related Toxicities
Hypomagnesemia
|
1 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Treatment-related Toxicities
Edema limbs
|
1 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Treatment-related Toxicities
Vomiting
|
1 participants
|
0 participants
|
10 participants
|
|
Number of Participants With Treatment-related Toxicities
Abdominal pain
|
0 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Treatment-related Toxicities
Anemia
|
0 participants
|
0 participants
|
13 participants
|
|
Number of Participants With Treatment-related Toxicities
Investigations - Other
|
0 participants
|
1 participants
|
5 participants
|
|
Number of Participants With Treatment-related Toxicities
Dysgeusia
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-related Toxicities
Alkaline phosphatase increased
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-related Toxicities
Hoarseness
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-related Toxicities
Fever
|
0 participants
|
1 participants
|
8 participants
|
|
Number of Participants With Treatment-related Toxicities
Neutrophil count decreased
|
0 participants
|
0 participants
|
23 participants
|
|
Number of Participants With Treatment-related Toxicities
Diarrhea
|
0 participants
|
0 participants
|
10 participants
|
|
Number of Participants With Treatment-related Toxicities
Hypokalemia
|
0 participants
|
0 participants
|
8 participants
|
|
Number of Participants With Treatment-related Toxicities
Weight loss
|
0 participants
|
0 participants
|
8 participants
|
|
Number of Participants With Treatment-related Toxicities
Gastrointestinal disorders - Other
|
0 participants
|
0 participants
|
6 participants
|
|
Number of Participants With Treatment-related Toxicities
Nasal congestion
|
0 participants
|
0 participants
|
5 participants
|
|
Number of Participants With Treatment-related Toxicities
Cough
|
0 participants
|
0 participants
|
5 participants
|
|
Number of Participants With Treatment-related Toxicities
Upper respiratory infection
|
0 participants
|
0 participants
|
5 participants
|
|
Number of Participants With Treatment-related Toxicities
Sinusitis
|
0 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Treatment-related Toxicities
Febrile neutropenia
|
0 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Treatment-related Toxicities
Bone pain
|
0 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Treatment-related Toxicities
Blurred vision
|
0 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Treatment-related Toxicities
Peripheral motor neuropathy
|
0 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Treatment-related Toxicities
Dyspnea
|
0 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Treatment-related Toxicities
Gastroesophageal reflux disease
|
0 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Treatment-related Toxicities
Lymphocyte count decreased
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-related Toxicities
Dizziness
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-related Toxicities
Hypoalbuminemia
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-related Toxicities
Hot flashes
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-related Toxicities
Aspartate aminotransferase increased
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-related Toxicities
Memory impairment
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-related Toxicities
Postnasal Drip
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-related Toxicities
Insomnia
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-related Toxicities
Pain
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-related Toxicities
Non-cardiac chest pain
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-related Toxicities
Hypoxia
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-related Toxicities
Portal vein thrombosis
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-related Toxicities
Sepsis
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-related Toxicities
Confusion
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-related Toxicities
Hypophosphatemia
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-related Toxicities
Pain in extremity
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-related Toxicities
Hypercalcemia
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-related Toxicities
Dysphagia
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-related Toxicities
Hyponatremia
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-related Toxicities
Myalgia
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsFor the purposes of Phase Ib dose escalation, DLTs will be defined as any treatment-related toxicity occurring within the first 21 days of combination therapy as grade 3 or 4 clinically evident non-hematologic toxicity; grade 4 neutropenia or thrombocytopenia lasting \> 7 days or febrile neutropenia; or any clinically significant toxicity grade 2 or higher that requires more than 14 days to resolve.
Outcome measures
| Measure |
Phase 1b: Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
n=3 Participants
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.1 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/ m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase 1b: 1.4 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
n=3 Participants
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.4 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)
Dose-expansion cohort will enroll patients with advanced breast cancer only after Phase Ib enrollment has been concluded. The MTD of Eribulin mesylate will be administered on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicity (DLT) for Participants With Any Solid Tumor (Phase 1b)
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 24 monthsThe ORR is defined as the proportion of participants displaying a CR or PR per RECIST criteria recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The participant's best response will depend on the achievement of both measurement and confirmation criteria with CR defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter and PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1b: Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
n=38 Participants
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.1 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/ m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase 1b: 1.4 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.4 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)
Dose-expansion cohort will enroll patients with advanced breast cancer only after Phase Ib enrollment has been concluded. The MTD of Eribulin mesylate will be administered on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
|---|---|---|---|
|
Overall Response Rate (ORR) for Participants With Advanced Breast Cancer (Phase II)
|
.131 proportion of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 monthsTime to progression will be evaluated as time from first treatment to tumor progression in weeks. Disease progression will be measured using Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (uni-dimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST 1.1 criteria.
Outcome measures
| Measure |
Phase 1b: Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
n=38 Participants
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.1 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/ m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase 1b: 1.4 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.4 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)
Dose-expansion cohort will enroll patients with advanced breast cancer only after Phase Ib enrollment has been concluded. The MTD of Eribulin mesylate will be administered on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
|---|---|---|---|
|
Time to Progression for Participants With Advanced Breast Cancer (Phase II)
|
16.4 weeks
Interval 13.8 to 21.1
|
—
|
—
|
Adverse Events
Phase 1b: 1.1 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1b: 1.4 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)
Serious events: 5 serious events
Other events: 38 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Phase 1b: 1.1 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
n=3 participants at risk
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.1 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase 1b: 1.4 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
n=3 participants at risk
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.4 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)
n=38 participants at risk
Dose-expansion cohort will enroll patients with advanced breast cancer only after Phase Ib enrollment has been concluded. The MTD of Eribulin mesylate will be administered on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
|---|---|---|---|
|
General disorders
Fever
|
0.00%
0/3 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
2.6%
1/38 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
2.6%
1/38 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
2.6%
1/38 • Number of events 1 • Up to 5 years
|
|
Investigations
Low Hematocrit
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
2.6%
1/38 • Number of events 1 • Up to 5 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
2.6%
1/38 • Number of events 1 • Up to 5 years
|
Other adverse events
| Measure |
Phase 1b: 1.1 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
n=3 participants at risk
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.1 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase 1b: 1.4 mg/m2 Eribulin Combination w/ Cyclophosphamide (Solid Tumor Escalation Cohort)
n=3 participants at risk
Dose escalation cohort will include all patients with solid tumors. Eribulin mesylate 1.4 mg/ m2 on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.The highest dose level at which no more than one of six subjects experience DLT defines the MTD
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
Phase II: Eribulin Combination w/ Cyclophosphamide (Breast Cancer Expansion Cohort)
n=38 participants at risk
Dose-expansion cohort will enroll patients with advanced breast cancer only after Phase Ib enrollment has been concluded. The MTD of Eribulin mesylate will be administered on days 1 and 8 followed by cyclophosphamide 600 mg/m2 on day 1 of a 21-day cycle.
Eribulin: Given intravenously (IV) Cyclophosphamide: Given IV
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 5 • Up to 5 years
|
100.0%
3/3 • Number of events 6 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
100.0%
3/3 • Number of events 3 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
13.2%
5/38 • Number of events 5 • Up to 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
10.5%
4/38 • Number of events 5 • Up to 5 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
7.9%
3/38 • Number of events 3 • Up to 5 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/3 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
66.7%
2/3 • Number of events 3 • Up to 5 years
|
33.3%
1/3 • Number of events 2 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
21.1%
8/38 • Number of events 10 • Up to 5 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
10.5%
4/38 • Number of events 7 • Up to 5 years
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
33.3%
1/3 • Number of events 4 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
General disorders
Edema Limbs
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
General disorders
Fever
|
0.00%
0/3 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
18.4%
7/38 • Number of events 9 • Up to 5 years
|
|
General disorders
Pain
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
18.4%
7/38 • Number of events 12 • Up to 5 years
|
|
General disorders
Chills
|
0.00%
0/3 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to 5 years
|
66.7%
2/3 • Number of events 7 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Investigations
White blood cell decreased
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
66.7%
2/3 • Number of events 6 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Investigations
Investigations - Other
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Investigations
Weight Loss
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
26.3%
10/38 • Number of events 12 • Up to 5 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to 5 years
|
66.7%
2/3 • Number of events 2 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
13.2%
5/38 • Number of events 5 • Up to 5 years
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 6 • Up to 5 years
|
|
Investigations
Hemoglobin increased
|
0.00%
0/3 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • Number of events 5 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
31.6%
12/38 • Number of events 13 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
28.9%
11/38 • Number of events 14 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
21.1%
8/38 • Number of events 10 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
7.9%
3/38 • Number of events 4 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
7.9%
3/38 • Number of events 4 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
47.4%
18/38 • Number of events 27 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
23.7%
9/38 • Number of events 10 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
23.7%
9/38 • Number of events 10 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
15.8%
6/38 • Number of events 7 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
10.5%
4/38 • Number of events 4 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
7.9%
3/38 • Number of events 3 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
7.9%
3/38 • Number of events 3 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
66.7%
2/3 • Number of events 3 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
23.7%
9/38 • Number of events 20 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 2 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 3 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 2 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
66.7%
2/3 • Number of events 3 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to 5 years
|
66.7%
2/3 • Number of events 2 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 2 • Up to 5 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
28.9%
11/38 • Number of events 12 • Up to 5 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
7.9%
3/38 • Number of events 7 • Up to 5 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 2 • Up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
7.9%
3/38 • Number of events 3 • Up to 5 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
23.7%
9/38 • Number of events 9 • Up to 5 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
15.8%
6/38 • Number of events 6 • Up to 5 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
10.5%
4/38 • Number of events 4 • Up to 5 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 2 • Up to 5 years
|
|
Eye disorders
Watering eyes
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
15.8%
6/38 • Number of events 6 • Up to 5 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
10.5%
4/38 • Number of events 4 • Up to 5 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
7.9%
3/38 • Number of events 3 • Up to 5 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
7.9%
3/38 • Number of events 3 • Up to 5 years
|
|
Renal and urinary disorders
Urinary Tract Pain
|
0.00%
0/3 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/38 • Up to 5 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 2 • Up to 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 2 • Up to 5 years
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 2 • Up to 5 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 2 • Up to 5 years
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 2 • Up to 5 years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
7.9%
3/38 • Number of events 5 • Up to 5 years
|
|
Vascular disorders
Lymphedema
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 3 • Up to 5 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
5.3%
2/38 • Number of events 2 • Up to 5 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
7.9%
3/38 • Number of events 3 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
13.2%
5/38 • Number of events 15 • Up to 5 years
|
Additional Information
Dr. Hope Rugo, MD
University of California, San Francisco
Phone: (415) 353-7618
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place