Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cyclin Dependent Kinase (CDK)4/6 Inhibitor, PD0332991 in Advanced Non-small Cell Lung Cancer NSCLC.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01291017
Recruitment Status : Completed
First Posted : February 7, 2011
Results First Posted : May 21, 2015
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer
Intervention Drug: PD0332991
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PD0332991
Hide Arm/Group Description

PD0332991 125 mg PO days 1 - 21

PD0332991: PD0332991 125 mg PO days 1 - 21

Period Title: Overall Study
Started 19
Completed 14
Not Completed 5
Reason Not Completed
Lost to Follow-up             2
Withdrawal by Subject             3
Arm/Group Title PD0332991
Hide Arm/Group Description

PD0332991 125 mg PO days 1 - 21

PD0332991: PD0332991 125 mg PO days 1 - 21

Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  36.8%
>=65 years
12
  63.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
9
  47.4%
Male
10
  52.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
1.Primary Outcome
Title Tumor Response by Direct RECIST Measurement
Hide Description Response is a decrease in the sum of the longest diameters of the target lesions by more than 30% compared to the baseline.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PD0332991
Hide Arm/Group Description:

PD0332991 125 mg PO days 1 - 21

PD0332991: PD0332991 125 mg PO days 1 - 21

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Overall Survival
Hide Description Median overall survival
Time Frame 14 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PD0332991
Hide Arm/Group Description:

PD0332991 125 mg PO days 1 - 21

PD0332991: PD0332991 125 mg PO days 1 - 21

Overall Number of Participants Analyzed 14
Median (Standard Error)
Unit of Measure: weeks
20.3  (1.7)
3.Secondary Outcome
Title Progression-free Survival
Hide Description Median progression-free survival.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PD0332991
Hide Arm/Group Description:

PD0332991 125 mg PO days 1 - 21

PD0332991: PD0332991 125 mg PO days 1 - 21

Overall Number of Participants Analyzed 16
Median (Standard Error)
Unit of Measure: Weeks
8  (0.7)
4.Secondary Outcome
Title Plasma Levels
Hide Description Plasma levels of p16, phosphorylated RB and cyclin d1 in blood.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
4 of the 16 samples were tested by protein immunoblot (Western blot), and due to the test not being sensitive enough to detect p16, phosphorylated RB or cyclin D1 protein bands in any of the samples, the decision was made not to purse this testing any further.
Arm/Group Title PD0332991
Hide Arm/Group Description:

PD0332991 125 mg PO days 1 - 21

PD0332991: PD0332991 125 mg PO days 1 - 21

Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: Arbitrary Units
NA [1] 
[1]
4 of the 16 samples were tested by Western blot, and due to the test not being sensitive enough to detect p16, phosphorylated RB or cyclin D1 protein bands in any of the samples, the decision was made not to pursue this testing any further.
5.Secondary Outcome
Title Grade of Study Drug Toxicity
Hide Description The number of all toxicities and grades 3 and 4 (per CTCAE v3.0) toxicities that occured during the administration of the drug and during the follow up period.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PD0332991
Hide Arm/Group Description:

PD0332991 125 mg PO days 1 - 21

PD0332991: PD0332991 125 mg PO days 1 - 21

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: Events
Grade 3 and 4 Toxicities 9
All Toxicities (Grades 1 - 5) 86
Time Frame Adverse events were collected from the signing of the Informed Consent Form through 30 days after the last dose of study drug (approximately 20 weeks).
Adverse Event Reporting Description All adverse events were assessed using the results of routine bloodwork, imaging or by a qualified healthcare provider.
 
Arm/Group Title PD0332991
Hide Arm/Group Description

PD0332991 125 mg PO days 1 - 21

PD0332991: PD0332991 125 mg PO days 1 - 21

All-Cause Mortality
PD0332991
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
PD0332991
Affected / at Risk (%) # Events
Total   2/19 (10.53%)    
Blood and lymphatic system disorders   
Neutrophil count decreased  1  1/19 (5.26%)  1
Investigations   
Aspartate aminotransferase  1  1/19 (5.26%)  1
Alanine aminotransferase  1  1/19 (5.26%)  1
Creatinine increased  1  1/19 (5.26%)  1
CPK increased  1  1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/19 (5.26%)  1
Generalized muscle weakness  1  1/19 (5.26%)  1
Renal and urinary disorders   
Acute kidney injury  1  1/19 (5.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PD0332991
Affected / at Risk (%) # Events
Total   16/19 (84.21%)    
Blood and lymphatic system disorders   
Anemia  1  4/19 (21.05%)  4
Neutrophil count decreased  1  5/19 (26.32%)  7
Platelet count decreased  1  4/19 (21.05%)  4
White blood cell decreased  1  2/19 (10.53%)  2
Ear and labyrinth disorders   
Vertigo  1  1/19 (5.26%)  1
Eye disorders   
Blurred vision  1  2/19 (10.53%)  2
Watering eyes  1  1/19 (5.26%)  1
Gastrointestinal disorders   
Abdominal pain  1  3/19 (15.79%)  3
Bloating  1  1/19 (5.26%)  1
Constipation  1  5/19 (26.32%)  5
Diarrhea  1  2/19 (10.53%)  2
Gastroesophageal reflux disease  1  1/19 (5.26%)  1
Mucositis oral  1  6/19 (31.58%)  8
Nausea  1  7/19 (36.84%)  10
Vomiting  1  6/19 (31.58%)  8
General disorders   
Edema limbs  1  1/19 (5.26%)  1
Fatigue  1  9/19 (47.37%)  13
General disorders and administration site conditions - Other, specify: Chills  1  1/19 (5.26%)  1
Non-cardiac chest pain  1  1/19 (5.26%)  1
Pain  1  2/19 (10.53%)  5
Pruritus  1  1/19 (5.26%)  2
Injury, poisoning and procedural complications   
Fall  1  1/19 (5.26%)  1
Investigations   
Alkaline phosphatase increased  1  1/19 (5.26%)  1
Metabolism and nutrition disorders   
Anorexia  1  4/19 (21.05%)  4
Dehydration  1  1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  1/19 (5.26%)  1
Bone pain  1  1/19 (5.26%)  1
Muscle weakness lower limb  1  1/19 (5.26%)  1
Musculoskeletal and connective tissue disorder - Other, specify: Body aches  1  1/19 (5.26%)  1
Musculoskeletal and connective tissue disorder - Other, specify: Muscle cramps  1  2/19 (10.53%)  2
Nervous system disorders   
Dizziness  1  3/19 (15.79%)  3
Dysgeusia  1  2/19 (10.53%)  2
Headache  1  2/19 (10.53%)  2
Tremor  1  1/19 (5.26%)  1
Psychiatric disorders   
Anxiety  1  2/19 (10.53%)  2
Confusion  1  1/19 (5.26%)  1
Depression  1  1/19 (5.26%)  1
Psychiatric disorders - Other, specify: Mood changes  1  2/19 (10.53%)  2
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/19 (15.79%)  3
Dyspnea  1  2/19 (10.53%)  2
Epistaxis  1  2/19 (10.53%)  2
Hoarseness  1  1/19 (5.26%)  2
Laryngeal hemorrhage  1  2/19 (10.53%)  2
Laryngeal inflammation  1  1/19 (5.26%)  1
Nasal congestion  1  1/19 (5.26%)  1
Productive cough  1  1/19 (5.26%)  2
Sore throat  1  2/19 (10.53%)  2
Upper respiratory infection  1  1/19 (5.26%)  1
Wheezing  1  1/19 (5.26%)  1
Skin and subcutaneous tissue disorders   
Photosensitivity  1  1/19 (5.26%)  1
Rash maculo-papular  1  2/19 (10.53%)  2
Vascular disorders   
Hot flashes  1  1/19 (5.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Priya K Gopalan, MD
Organization: University of Florida
Phone: 352-273-8699
EMail: gopalpk@ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01291017    
Other Study ID Numbers: PD0332991
First Submitted: February 1, 2011
First Posted: February 7, 2011
Results First Submitted: March 12, 2015
Results First Posted: May 21, 2015
Last Update Posted: May 13, 2016