Trial Outcomes & Findings for Dinaciclib in Treating Patients With Stage III-IV Melanoma (NCT NCT01026324)
NCT ID: NCT01026324
Last Updated: 2017-04-04
Results Overview
Due to difficult accrual to the trial, enrollment was ended early without determination of an MTD.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
14 days
Results posted on
2017-04-04
Participant Flow
Subjects were screened and enrolled at one site in the US, Dana Farber Cancer Institute.
Participant milestones
| Measure |
Treatment (Dinaciclib) Dose Level 1
Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Treatment (Dinaciclib) Dose Level 2
Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Treatment (Dinaciclib) Dose Level 3
Patients receive dinaciclib at Dose Level 3(30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|
|
Treatment Allocation
STARTED
|
5
|
3
|
4
|
|
Treatment Allocation
Discontinued Intervention (Toxicity)
|
1
|
0
|
0
|
|
Treatment Allocation
Discontinuted Intervention (Progression)
|
3
|
3
|
4
|
|
Treatment Allocation
Discontinued Intervention (Withdrew)
|
1
|
0
|
0
|
|
Treatment Allocation
COMPLETED
|
5
|
3
|
4
|
|
Treatment Allocation
NOT COMPLETED
|
0
|
0
|
0
|
|
Follow up/Survival
STARTED
|
5
|
3
|
4
|
|
Follow up/Survival
Follow up Discontinuation (Death)
|
4
|
3
|
4
|
|
Follow up/Survival
COMPLETED
|
4
|
3
|
4
|
|
Follow up/Survival
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment (Dinaciclib) Dose Level 1
Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Treatment (Dinaciclib) Dose Level 2
Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Treatment (Dinaciclib) Dose Level 3
Patients receive dinaciclib at Dose Level 3(30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|
|
Follow up/Survival
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Dinaciclib in Treating Patients With Stage III-IV Melanoma
Baseline characteristics by cohort
| Measure |
Treatment (Dinaciclib) Dose Level 1
n=5 Participants
Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
|
Treatment (Dinaciclib) Dose Level 2
n=3 Participants
Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
|
Treatment (Dinaciclib) Dose Level 3
n=4 Participants
Patients receive dinaciclib at Dose Level 3 (30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Due to difficult accrual to the trial, enrollment was ended early without determination of an MTD.
Due to difficult accrual to the trial, enrollment was ended early without determination of an MTD.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Due to difficult accrual to the trial, enrollment was ended early without entering into Phase II
Due to difficult accrual to the trial, enrollment was ended early without entering into Phase II
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 monthsOutcome measures
| Measure |
Treatment (Dinaciclib)
n=5 Participants
Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV
|
Treatment (Dinaciclib) Dose Level 2
n=3 Participants
Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV
|
Treatment (Dinaciclib) Dose Level 3
n=4 Participants
Patients receive dinaciclib at Dose Level 3 (30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
dinaciclib: Given IV
|
|---|---|---|---|
|
Progression-free Survival
Stable Disease
|
2 participants
|
0 participants
|
0 participants
|
|
Progression-free Survival
Progressive Disease
|
1 participants
|
3 participants
|
4 participants
|
|
Progression-free Survival
Unevaluable
|
2 participants
|
0 participants
|
0 participants
|
Adverse Events
Dose Level 1 - Treatment (Dinaciclib)
Serious events: 5 serious events
Other events: 5 other events
Deaths: 5 deaths
Dose Level 2 - Treatment (Dinaciclib)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Dose Level 3 - Treatment (Dinaciclib)
Serious events: 4 serious events
Other events: 4 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Dose Level 1 - Treatment (Dinaciclib)
n=5 participants at risk
Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
Dose: 10 MG/M2
Dinaciclib: Given IV
Pharmacological study: Correlative studies
Laboratory biomarker analysis: Correlative studies
|
Dose Level 2 - Treatment (Dinaciclib)
n=3 participants at risk
Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
Dose: 20 MG/M2
Dinaciclib: Given IV
Pharmacological study: Correlative studies
Laboratory biomarker analysis: Correlative studies
|
Dose Level 3 - Treatment (Dinaciclib)
n=4 participants at risk
Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
Dose: 30 MG/M2
Dinaciclib: Given IV
Pharmacological study: Correlative studies
Laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytes
|
20.0%
1/5
|
33.3%
1/3
|
75.0%
3/4
|
|
Blood and lymphatic system disorders
Neutrophils
|
20.0%
1/5
|
100.0%
3/3
|
100.0%
4/4
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/5
|
100.0%
3/3
|
50.0%
2/4
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/5
|
33.3%
1/3
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/5
|
33.3%
1/3
|
25.0%
1/4
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
1/5
|
33.3%
1/3
|
25.0%
1/4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/4
|
|
Nervous system disorders
Syncope
|
0.00%
0/5
|
33.3%
1/3
|
0.00%
0/4
|
Other adverse events
| Measure |
Dose Level 1 - Treatment (Dinaciclib)
n=5 participants at risk
Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
Dose: 10 MG/M2
Dinaciclib: Given IV
Pharmacological study: Correlative studies
Laboratory biomarker analysis: Correlative studies
|
Dose Level 2 - Treatment (Dinaciclib)
n=3 participants at risk
Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
Dose: 20 MG/M2
Dinaciclib: Given IV
Pharmacological study: Correlative studies
Laboratory biomarker analysis: Correlative studies
|
Dose Level 3 - Treatment (Dinaciclib)
n=4 participants at risk
Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
Dose: 30 MG/M2
Dinaciclib: Given IV
Pharmacological study: Correlative studies
Laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
40.0%
2/5
|
33.3%
1/3
|
25.0%
1/4
|
|
Blood and lymphatic system disorders
Leukocytes
|
40.0%
2/5
|
100.0%
3/3
|
100.0%
4/4
|
|
Blood and lymphatic system disorders
Lymphopenia
|
40.0%
2/5
|
100.0%
3/3
|
50.0%
2/4
|
|
Blood and lymphatic system disorders
Neutrophils
|
20.0%
1/5
|
100.0%
3/3
|
100.0%
4/4
|
|
Cardiac disorders
Hypertension
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/4
|
|
Cardiac disorders
Hypotension
|
0.00%
0/5
|
33.3%
1/3
|
0.00%
0/4
|
|
General disorders
Fatigue
|
60.0%
3/5
|
0.00%
0/3
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Rash
|
40.0%
2/5
|
0.00%
0/3
|
25.0%
1/4
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/5
|
33.3%
1/3
|
0.00%
0/4
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/5
|
33.3%
1/3
|
25.0%
1/4
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5
|
66.7%
2/3
|
75.0%
3/4
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5
|
66.7%
2/3
|
25.0%
1/4
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5
|
66.7%
2/3
|
50.0%
2/4
|
|
Blood and lymphatic system disorders
Edema limb
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/4
|
|
Hepatobiliary disorders
ALT- SGPT
|
40.0%
2/5
|
33.3%
1/3
|
25.0%
1/4
|
|
Hepatobiliary disorders
AST- SGOT
|
60.0%
3/5
|
66.7%
2/3
|
25.0%
1/4
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Bicarbonate
|
0.00%
0/5
|
33.3%
1/3
|
0.00%
0/4
|
|
General disorders
Hyperglycemia
|
60.0%
3/5
|
0.00%
0/3
|
25.0%
1/4
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
0.00%
0/5
|
33.3%
1/3
|
0.00%
0/4
|
|
Renal and urinary disorders
Hyperuricemia
|
40.0%
2/5
|
66.7%
2/3
|
25.0%
1/4
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
40.0%
2/5
|
33.3%
1/3
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
40.0%
2/5
|
66.7%
2/3
|
50.0%
2/4
|
|
General disorders
Hypoglycemia
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Hypokalemia
|
60.0%
3/5
|
0.00%
0/3
|
25.0%
1/4
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
20.0%
1/5
|
33.3%
1/3
|
50.0%
2/4
|
|
Blood and lymphatic system disorders
Hyponatremia
|
40.0%
2/5
|
0.00%
0/3
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
40.0%
2/5
|
100.0%
3/3
|
25.0%
1/4
|
|
Nervous system disorders
Syncope
|
0.00%
0/5
|
33.3%
1/3
|
0.00%
0/4
|
|
General disorders
Back-pain
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/4
|
|
General disorders
Chest wall-pain
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/4
|
|
General disorders
Head/headache
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5
|
0.00%
0/3
|
0.00%
0/4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60