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Dinaciclib in Treating Patients With Stage III-IV Melanoma

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ClinicalTrials.gov Identifier: NCT01026324
Recruitment Status : Terminated (Slow accrual)
First Posted : December 4, 2009
Results First Posted : August 3, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stage IIIB Melanoma
Stage IIIC Melanoma
Stage IV Melanoma
Interventions Drug: dinaciclib
Other: pharmacological study
Other: laboratory biomarker analysis
Enrollment 12
Recruitment Details Subjects were screened and enrolled at one site in the US, Dana Farber Cancer Institute.
Pre-assignment Details  
Arm/Group Title Treatment (Dinaciclib) Dose Level 1 Treatment (Dinaciclib) Dose Level 2 Treatment (Dinaciclib) Dose Level 3
Hide Arm/Group Description

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

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

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

Period Title: Treatment Allocation
Started 5 3 4
Discontinued Intervention (Toxicity) 1 0 0
Discontinuted Intervention (Progression) 3 3 4
Discontinued Intervention (Withdrew) 1 0 0
Completed 5 3 4
Not Completed 0 0 0
Period Title: Follow up/Survival
Started 5 3 4
Follow up Discontinuation (Death) 4 3 4
Completed 4 3 4
Not Completed 1 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0
Arm/Group Title Treatment (Dinaciclib) Dose Level 1 Treatment (Dinaciclib) Dose Level 2 Treatment (Dinaciclib) Dose Level 3 Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 5 3 4 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 4 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  80.0%
2
  66.7%
4
 100.0%
10
  83.3%
>=65 years
1
  20.0%
1
  33.3%
0
   0.0%
2
  16.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 4 participants 12 participants
Female
2
  40.0%
2
  66.7%
1
  25.0%
5
  41.7%
Male
3
  60.0%
1
  33.3%
3
  75.0%
7
  58.3%
1.Primary Outcome
Title Recommended Phase-2 Dose of SCH727965
Hide Description Due to difficult accrual to the trial, enrollment was ended early without determination of an MTD.
Time Frame 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to difficult accrual to the trial, enrollment was ended early without determination of an MTD.
Arm/Group Title Treatment (Dinaciclib)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Percentage of Patients Alive (Phase II)
Hide Description Due to difficult accrual to the trial, enrollment was ended early without entering into Phase II
Time Frame Up to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to difficult accrual to the trial, enrollment was ended early without entering into Phase II
Arm/Group Title Treatment (Dinaciclib)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Progression-free Survival
Hide Description [Not Specified]
Time Frame Up to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Dinaciclib) Dose Level 1 Treatment (Dinaciclib) Dose Level 2 Treatment (Dinaciclib) Dose Level 3
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 5 3 4
Measure Type: Number
Unit of Measure: participants
Stable Disease 2 0 0
Progressive Disease 1 3 4
Unevaluable 2 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dose Level 1 - Treatment (Dinaciclib) Dose Level 2 - Treatment (Dinaciclib) Dose Level 3 - Treatment (Dinaciclib)
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Dose Level 1 - Treatment (Dinaciclib) Dose Level 2 - Treatment (Dinaciclib) Dose Level 3 - Treatment (Dinaciclib)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/5 (100.00%)   3/3 (100.00%)   4/4 (100.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Dose Level 1 - Treatment (Dinaciclib) Dose Level 2 - Treatment (Dinaciclib) Dose Level 3 - Treatment (Dinaciclib)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/5 (100.00%)   3/3 (100.00%)   4/4 (100.00%) 
Blood and lymphatic system disorders       
Leukocytes  1/5 (20.00%)  1/3 (33.33%)  3/4 (75.00%) 
Neutrophils  1/5 (20.00%)  3/3 (100.00%)  4/4 (100.00%) 
Lymphopenia  0/5 (0.00%)  3/3 (100.00%)  2/4 (50.00%) 
Gastrointestinal disorders       
Dehydration  0/5 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Metabolism and nutrition disorders       
Hyperuricemia  0/5 (0.00%)  1/3 (33.33%)  1/4 (25.00%) 
Hyponatremia  1/5 (20.00%)  0/3 (0.00%)  0/4 (0.00%) 
Hypophosphatemia  1/5 (20.00%)  1/3 (33.33%)  1/4 (25.00%) 
Nervous system disorders       
Syncope  0/5 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1/5 (20.00%)  0/3 (0.00%)  0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dose Level 1 - Treatment (Dinaciclib) Dose Level 2 - Treatment (Dinaciclib) Dose Level 3 - Treatment (Dinaciclib)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/5 (100.00%)   3/3 (100.00%)   4/4 (100.00%) 
Blood and lymphatic system disorders       
Hemoglobin  2/5 (40.00%)  1/3 (33.33%)  1/4 (25.00%) 
Leukocytes  2/5 (40.00%)  3/3 (100.00%)  4/4 (100.00%) 
Lymphopenia  2/5 (40.00%)  3/3 (100.00%)  2/4 (50.00%) 
Neutrophils  1/5 (20.00%)  3/3 (100.00%)  4/4 (100.00%) 
Edema limb  1/5 (20.00%)  0/3 (0.00%)  0/4 (0.00%) 
Hyperkalemia  0/5 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Hypoalbuminemia  2/5 (40.00%)  1/3 (33.33%)  0/4 (0.00%) 
Hypocalcemia  2/5 (40.00%)  2/3 (66.67%)  2/4 (50.00%) 
Hypokalemia  3/5 (60.00%)  0/3 (0.00%)  1/4 (25.00%) 
Hypomagnesemia  1/5 (20.00%)  1/3 (33.33%)  2/4 (50.00%) 
Hyponatremia  2/5 (40.00%)  0/3 (0.00%)  0/4 (0.00%) 
Hypophosphatemia  2/5 (40.00%)  3/3 (100.00%)  1/4 (25.00%) 
Cardiac disorders       
Hypertension  1/5 (20.00%)  0/3 (0.00%)  0/4 (0.00%) 
Hypotension  0/5 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Gastrointestinal disorders       
Anorexia  0/5 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Dehydration  0/5 (0.00%)  1/3 (33.33%)  1/4 (25.00%) 
Diarrhea  0/5 (0.00%)  2/3 (66.67%)  3/4 (75.00%) 
Nausea  1/5 (20.00%)  2/3 (66.67%)  1/4 (25.00%) 
Vomiting  1/5 (20.00%)  2/3 (66.67%)  2/4 (50.00%) 
General disorders       
Fatigue  3/5 (60.00%)  0/3 (0.00%)  0/4 (0.00%) 
Hyperglycemia  3/5 (60.00%)  0/3 (0.00%)  1/4 (25.00%) 
Hypoglycemia  1/5 (20.00%)  0/3 (0.00%)  0/4 (0.00%) 
Back-pain  1/5 (20.00%)  0/3 (0.00%)  0/4 (0.00%) 
Chest wall-pain  1/5 (20.00%)  0/3 (0.00%)  0/4 (0.00%) 
Head/headache  1/5 (20.00%)  0/3 (0.00%)  0/4 (0.00%) 
Hepatobiliary disorders       
ALT- SGPT  2/5 (40.00%)  1/3 (33.33%)  1/4 (25.00%) 
AST- SGOT  3/5 (60.00%)  2/3 (66.67%)  1/4 (25.00%) 
Alkaline phosphatase  1/5 (20.00%)  0/3 (0.00%)  0/4 (0.00%) 
Nervous system disorders       
Syncope  0/5 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Renal and urinary disorders       
Hyperuricemia  2/5 (40.00%)  2/3 (66.67%)  1/4 (25.00%) 
Respiratory, thoracic and mediastinal disorders       
Bicarbonate  0/5 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Cough  1/5 (20.00%)  0/3 (0.00%)  0/4 (0.00%) 
Dyspnea  1/5 (20.00%)  0/3 (0.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash  2/5 (40.00%)  0/3 (0.00%)  1/4 (25.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: F. Stephen Hodi, MD
Organization: Dana-Farber Cancer Institute
Phone: 617-632-5053
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01026324     History of Changes
Other Study ID Numbers: NCI-2013-00522
NCI-2013-00522 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
09-152 ( Other Identifier: Dana-Farber Cancer Institute )
8296 ( Other Identifier: CTEP )
U01CA062490 ( U.S. NIH Grant/Contract )
P30CA006516 ( U.S. NIH Grant/Contract )
First Submitted: December 3, 2009
First Posted: December 4, 2009
Results First Submitted: February 9, 2016
Results First Posted: August 3, 2016
Last Update Posted: April 4, 2017