Trial Outcomes & Findings for Phase II Trial Of ZK-EPO (ZK 219477) (Sagopilone) In Metastatic Melanoma (NCT NCT00598507)
NCT ID: NCT00598507
Last Updated: 2013-12-11
Results Overview
Objective tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
COMPLETED
PHASE2
35 participants
Up to 5 years
2013-12-11
Participant Flow
Accrual began in May 2007 at Moffitt Cancer Center and was completed in October 2008.
Participant milestones
| Measure |
Chemotherapy - ZK-EPO
ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m\^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Trial Of ZK-EPO (ZK 219477) (Sagopilone) In Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Chemotherapy - ZK-EPO
n=35 Participants
ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m\^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
|
Age Continuous
|
68.7 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: All participants
Objective tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Outcome measures
| Measure |
Chemotherapy - ZK-EPO
n=35 Participants
ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m\^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
|
|---|---|
|
Response Rate (RR)
Confirmed Complete Response
|
1 participants
|
|
Response Rate (RR)
Confirmed Partial Response
|
2 participants
|
|
Response Rate (RR)
Unconfirmed Partial Response
|
1 participants
|
|
Response Rate (RR)
Stable Disease for at Least 12 Weeks
|
8 participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All participants
PFS: the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD)according to modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Outcome measures
| Measure |
Chemotherapy - ZK-EPO
n=35 Participants
ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m\^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
|
|---|---|
|
Median Progression Free Survival (PFS)
|
7.5 weeks
Interval 6.4 to 8.7
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All participants
Median OS: the time (expressed in months or years) when half the patients are expected to be alive.
Outcome measures
| Measure |
Chemotherapy - ZK-EPO
n=35 Participants
ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m\^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
|
|---|---|
|
Median Overall Survival (OS)
|
31 weeks
Interval 14.9 to 47.1
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All participants
Number of participants with Grade 3 or higher adverse events, attributable to treatment with sagopilone.
Outcome measures
| Measure |
Chemotherapy - ZK-EPO
n=35 Participants
ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m\^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
|
|---|---|
|
Occurrence of Attributable Serious Adverse Events (SAEs)
|
0 participants
|
Adverse Events
Chemotherapy - ZK-EPO
Serious adverse events
| Measure |
Chemotherapy - ZK-EPO
n=35 participants at risk
ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m\^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
|
|---|---|
|
General disorders
Confusion
|
2.9%
1/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Metabolism and nutrition disorders
Creatinine - high
|
2.9%
1/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
2.9%
1/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Gastrointestinal disorders
Dehydration
|
2.9%
1/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
General disorders
Fever in the absence of neutropenia
|
2.9%
1/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
2.9%
1/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Cardiac disorders
Pulmonary hypertension
|
2.9%
1/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
5.7%
2/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
General disorders
Syncope (fainting)
|
2.9%
1/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
Other adverse events
| Measure |
Chemotherapy - ZK-EPO
n=35 participants at risk
ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m\^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
|
|---|---|
|
Nervous system disorders
Neuropathy: sensory
|
54.3%
19/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Nervous system disorders
Neuropathy: motor
|
22.9%
8/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
General disorders
Confusion
|
5.7%
2/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Blood and lymphatic system disorders
Hemoglobin - low
|
31.4%
11/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC) - low
|
22.9%
8/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC) - low
|
14.3%
5/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Blood and lymphatic system disorders
Platelets - low
|
14.3%
5/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
37.1%
13/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
General disorders
Fever (in the absence of neutropenia)
|
8.6%
3/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
General disorders
Constitutional Symptoms - Other
|
5.7%
2/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
General disorders
Pain - Extremity-limb
|
20.0%
7/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
General disorders
Pain - Joint
|
20.0%
7/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
General disorders
Pain - Muscle
|
14.3%
5/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
General disorders
Pain - Back
|
8.6%
3/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
General disorders
Pain - Bone
|
5.7%
2/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
General disorders
Pain - Head/headache
|
5.7%
2/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
28.6%
10/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
14.3%
5/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
11.4%
4/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
5.7%
2/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase) - high
|
5.7%
2/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase) - high
|
5.7%
2/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
5.7%
2/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Gastrointestinal disorders
Nausea
|
31.4%
11/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Gastrointestinal disorders
Anorexia
|
22.9%
8/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Gastrointestinal disorders
Constipation
|
17.1%
6/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Gastrointestinal disorders
Vomiting
|
11.4%
4/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Gastrointestinal disorders
Dehydration
|
5.7%
2/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Gastrointestinal disorders
Diarrhea
|
5.7%
2/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
7/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
20.0%
7/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
5.7%
2/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
11.4%
4/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
11.4%
4/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Cardiac disorders
Hypotension
|
5.7%
2/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lymphatic
|
5.7%
2/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
|
Blood and lymphatic system disorders
Edema: limb
|
14.3%
5/35 • Up to 5 years
Participants treated with at least one dose of sagopilone.
|
Additional Information
Ronald DeConti, M.D., Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place