Trial Outcomes & Findings for A Phase II Study of UCN-01 in Metastatic Melanoma (NCT NCT00072189)
NCT ID: NCT00072189
Last Updated: 2015-03-02
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Up to 7 years
Results posted on
2015-03-02
Participant Flow
Participant milestones
| Measure |
Arm 1
Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
7-hydroxystaurosporine: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Arm 1
Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
7-hydroxystaurosporine: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Phase II Study of UCN-01 in Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Arm 1
n=17 Participants
Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
7-hydroxystaurosporine: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Age, Continuous
|
53 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 7 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Arm 1
n=16 Participants
Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
7-hydroxystaurosporine: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Response Rate
|
0 percentage of responding participants
|
SECONDARY outcome
Timeframe: Up to 7 yearsEstimated using the product-limit method of Kaplan and Meier.
Outcome measures
| Measure |
Arm 1
n=17 Participants
Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
7-hydroxystaurosporine: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Overall Survival
|
7.3 months
Interval 3.4 to 18.4
|
SECONDARY outcome
Timeframe: From the date of study registration to the first documentation of progressive tumor, assessed up to 7 yearsEstimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Arm 1
n=17 Participants
Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
7-hydroxystaurosporine: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Progression-free Survival
|
1.3 months
Interval 1.2 to 3.0
|
Adverse Events
Arm 1
Serious events: 7 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=17 participants at risk
Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
7-hydroxystaurosporine: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Haematemesis
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Packed red blood cell transfusion
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
5.9%
1/17 • Number of events 2 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
General symptom
|
11.8%
2/17 • Number of events 2 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.8%
2/17 • Number of events 2 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
Arm 1
n=17 participants at risk
Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
7-hydroxystaurosporine: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
41.2%
7/17 • Number of events 16 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Packed red blood cell transfusion
|
11.8%
2/17 • Number of events 2 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
11.8%
2/17 • Number of events 2 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Hearing loss
|
5.9%
1/17 • Number of events 5 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
5.9%
1/17 • Number of events 2 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
3/17 • Number of events 4 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
11.8%
2/17 • Number of events 4 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
11.8%
2/17 • Number of events 2 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastritis
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
64.7%
11/17 • Number of events 12 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
35.3%
6/17 • Number of events 7 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
64.7%
11/17 • Number of events 25 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
General symptom
|
41.2%
7/17 • Number of events 7 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Oedema NOS
|
11.8%
2/17 • Number of events 2 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
11.8%
2/17 • Number of events 4 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infection NOS
|
11.8%
2/17 • Number of events 2 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
11.8%
2/17 • Number of events 4 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
11.8%
2/17 • Number of events 3 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
23.5%
4/17 • Number of events 7 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
23.5%
4/17 • Number of events 5 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hyperbilirubinemia
|
11.8%
2/17 • Number of events 2 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hypercholesterolemia
|
29.4%
5/17 • Number of events 16 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukopenia
|
17.6%
3/17 • Number of events 11 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphopenia
|
17.6%
3/17 • Number of events 13 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight loss
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
17.6%
3/17 • Number of events 4 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
88.2%
15/17 • Number of events 31 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
47.1%
8/17 • Number of events 11 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
23.5%
4/17 • Number of events 6 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.6%
3/17 • Number of events 3 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
17.6%
3/17 • Number of events 3 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
35.3%
6/17 • Number of events 6 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
5.9%
1/17 • Number of events 2 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
11.8%
2/17 • Number of events 3 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
11.8%
2/17 • Number of events 2 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
11.8%
2/17 • Number of events 2 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
29.4%
5/17 • Number of events 5 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Neurological disorder NOS
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.8%
2/17 • Number of events 5 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Confusion
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.6%
3/17 • Number of events 4 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.6%
3/17 • Number of events 3 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
5.9%
1/17 • Number of events 2 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
1/17 • Number of events 11 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
17.6%
3/17 • Number of events 3 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
5.9%
1/17 • Number of events 1 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • Number of events 2 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
11.8%
2/17 • Number of events 2 • Collected over a period of 24 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
DCC Project Administrator
California Cancer Consortium
Phone: : 626-256-4673
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60