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Trial record 44 of 78 for:    vismodegib

Vismodegib and Gemcitabine Hydrochloride in Treating Patients With Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01195415
Recruitment Status : Completed
First Posted : September 6, 2010
Results First Posted : October 7, 2015
Last Update Posted : August 7, 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 Recurrent Pancreatic Carcinoma
Stage IV Pancreatic Cancer
Interventions Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Vismodegib
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Vismodegib, Gemcitabine Hydrochloride)
Hide Arm/Group Description Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 25
Completed 23
Not Completed 2
Reason Not Completed
No repeat biopsy due to progression             2
Arm/Group Title Treatment (Vismodegib, Gemcitabine Hydrochloride)
Hide Arm/Group Description Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
Patients treated on protocol.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants
65
(46 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
10
  40.0%
Male
15
  60.0%
1.Primary Outcome
Title Median Percent at Baseline and 3 Weeks in CD44+/ CD24+/ ESA+ Cells From Needle Biopsy Calculated Using FACS
Hide Description The median percentage of CD44+CD24+ESA+ cells from needle biopsy were calculated at baseline and at 3 weeks using FACS. The difference between the two time points was calculated.
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 25 patients enrolled, only 22 were evaluable for the primary endpoint.
Arm/Group Title Treatment (Vismodegib, Gemcitabine Hydrochloride)
Hide Arm/Group Description:
Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 22
Median (Full Range)
Unit of Measure: percentage of CD44+/ CD24+/ ESA+ cells
Baseline Median % of CD44+/CD24+/ESA+ CSCs
4.79
(0.43 to 37.2)
3 Weeks Post Tx Median % of CD44+/CD24+/ESA+ CSCs
3.09
(0.74 to 45.9)
2.Secondary Outcome
Title The Number of Participants With an Objective Best Response (CR + PR)
Hide Description The number of participants with either a complete response (CR) or a partial response (PR) will be calculated. A CR is defined as the disappearance of all target lesions. A PR is defined as at least a 30% decrease in the sum of the diameters of target lesions.
Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients were evaluable.
Arm/Group Title Treatment (Vismodegib, Gemcitabine Hydrochloride)
Hide Arm/Group Description:
Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
5
3.Secondary Outcome
Title Median Progression Free Survival
Hide Description Median progression free survival was calculated for all treated patients. Assessed using the Kaplan-Meier method. The 95% confidence interval for this estimate will be computed using the Greenwood’s formula.
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Vismodegib, Gemcitabine Hydrochloride)
Hide Arm/Group Description:
Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: months
2.8
(1.4 to 4.7)
4.Secondary Outcome
Title Percentage of Treated Patients Experiencing Grade 3+ Toxicity Per National Cancer Institute Common Toxicity Criteria (CTC) Version 3.0
Hide Description [Not Specified]
Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Vismodegib, Gemcitabine Hydrochloride)
Hide Arm/Group Description:
Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: percentage of patients
56
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Vismodegib, Gemcitabine Hydrochloride)
Hide Arm/Group Description Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Treatment (Vismodegib, Gemcitabine Hydrochloride)
Affected / at Risk (%)
Total   1/25 (4.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Vismodegib, Gemcitabine Hydrochloride)
Affected / at Risk (%) # Events
Total   16/25 (64.00%)    
Blood and lymphatic system disorders   
Febrile Neutropenia  1/25 (4.00%)  1
Gastrointestinal disorders   
Abdominal pain  2/25 (8.00%)  2
Duodenal stenosis  1/25 (4.00%)  1
Small intestinal obstruction  1/25 (4.00%)  1
Upper gastrointestinal hemorrhage  1/25 (4.00%)  1
Vomiting  1/25 (4.00%)  1
General disorders   
Fatigue  1/25 (4.00%)  1
Fever  1/25 (4.00%)  1
General disorders and administration site conditions - Other  2/25 (8.00%)  2
Multi-organ failure  1/25 (4.00%)  1
Death [1]  1/25 (4.00%)  1
Hepatobiliary disorders   
Hepatobiliary disorders - Other  1/25 (4.00%)  1
Investigations   
Aspartate aminotransferase increased  1/25 (4.00%)  1
Blood bilirubin increased  1/25 (4.00%)  1
Metabolism and nutrition disorders   
Anorexia  1/25 (4.00%)  1
Dehydration  3/25 (12.00%)  3
Hypercalcemia  1/25 (4.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other  2/25 (8.00%)  2
Nervous system disorders   
Cognitive disturbance  1/25 (4.00%)  1
Renal and urinary disorders   
Urinary tract obstruction  1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1/25 (4.00%)  1
Pleural effusion  1/25 (4.00%)  1
Surgical and medical procedures   
Surgical and medical procedures - Other  1/25 (4.00%)  1
Vascular disorders   
Hypotension  2/25 (8.00%)  2
Superior vena cava syndrome  1/25 (4.00%)  1
Thromboembolic event  1/25 (4.00%)  1
[1]
Death due to disease progression
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Vismodegib, Gemcitabine Hydrochloride)
Affected / at Risk (%) # Events
Total   25/25 (100.00%)    
Blood and lymphatic system disorders   
Anemia  17/25 (68.00%)  29
Cardiac disorders   
Chest pain - cardiac  2/25 (8.00%)  2
Ear and labyrinth disorders   
Tinnitus  3/25 (12.00%)  3
Vertigo  2/25 (8.00%)  2
Eye disorders   
Photophobia  2/25 (8.00%)  2
Gastrointestinal disorders   
Abdominal distension  4/25 (16.00%)  5
Abdominal pain  13/25 (52.00%)  19
Ascites  3/25 (12.00%)  4
Constipation  7/25 (28.00%)  9
Diarrhea  8/25 (32.00%)  8
Dry mouth  3/25 (12.00%)  3
Dyspepsia  3/25 (12.00%)  3
Flatulence  2/25 (8.00%)  2
Gastroesophageal reflux disease  2/25 (8.00%)  2
Gastroparesis  2/25 (8.00%)  2
Nausea  14/25 (56.00%)  16
Vomiting  13/25 (52.00%)  15
General disorders   
Chills  3/25 (12.00%)  3
Edema limbs  7/25 (28.00%)  8
Fatigue  18/25 (72.00%)  28
Fever  10/25 (40.00%)  14
General disorders and administration site conditions - Other  2/25 (8.00%)  2
Non-cardiac chest pain  2/25 (8.00%)  2
Hepatobiliary disorders   
Hepatobiliary disorders - Other  2/25 (8.00%)  2
Infections and infestations   
Papulopustular rash  3/25 (12.00%)  3
Investigations   
Alanine aminotransferase increased  17/25 (68.00%)  22
Aspartate aminotransferase increased  18/25 (72.00%)  24
Blood bilirubin increased  8/25 (32.00%)  11
CD4 lymphocytes decreased  3/25 (12.00%)  6
Creatinine increased  3/25 (12.00%)  3
Lipase increased  2/25 (8.00%)  2
Lymphocyte count decreased  11/25 (44.00%)  12
Neutrophil count decreased  8/25 (32.00%)  9
Platelet count decreased  13/25 (52.00%)  18
Weight gain  6/25 (24.00%)  6
Weight loss  10/25 (40.00%)  12
White blood cell decreased  10/25 (40.00%)  13
Metabolism and nutrition disorders   
Anorexia  19/25 (76.00%)  24
Dehydration  5/25 (20.00%)  5
Hypercalcemia  4/25 (16.00%)  4
Hyperglycemia  18/25 (72.00%)  22
Hyperkalemia  9/25 (36.00%)  11
Hypoalbuminemia  11/25 (44.00%)  16
Hypocalcemia  13/25 (52.00%)  17
Hypoglycemia  2/25 (8.00%)  2
Hyponatremia  19/25 (76.00%)  23
Hypophosphatemia  11/25 (44.00%)  14
Musculoskeletal and connective tissue disorders   
Arthralgia  4/25 (16.00%)  4
Arthritis  3/25 (12.00%)  3
Back pain  5/25 (20.00%)  6
Myalgia  7/25 (28.00%)  10
Pain in extremity  3/25 (12.00%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other  2/25 (8.00%)  2
Nervous system disorders   
Dizziness  4/25 (16.00%)  4
Dysgeusia  14/25 (56.00%)  16
Headache  6/25 (24.00%)  6
Somnolence  3/25 (12.00%)  3
Psychiatric disorders   
Anxiety  7/25 (28.00%)  7
Confusion  3/25 (12.00%)  4
Depression  5/25 (20.00%)  5
Insomnia  3/25 (12.00%)  3
Renal and urinary disorders   
Renal and urinary disorders - Other  2/25 (8.00%)  2
Urinary frequency  2/25 (8.00%)  2
Respiratory, thoracic and mediastinal disorders   
Cough  6/25 (24.00%)  7
Dyspnea  7/25 (28.00%)  8
Hiccups  2/25 (8.00%)  2
Productive cough  5/25 (20.00%)  5
Skin and subcutaneous tissue disorders   
Alopecia  8/25 (32.00%)  10
Pruritus  3/25 (12.00%)  3
Rash maculo-papular  2/25 (8.00%)  2
Vascular disorders   
Hypertension  2/25 (8.00%)  2
Hypotension  7/25 (28.00%)  8
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: Dr. Mark Zalupski, M.D.
Organization: University of Michigan Comprehensive Cancer Center
Phone: 734-615-3969
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01195415     History of Changes
Obsolete Identifiers: NCT01143415
Other Study ID Numbers: NCI-2011-03746
NCI-2011-03746 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
UMCC 2010-003 ( Other Identifier: University of Michigan Comprehensive Cancer Center )
8417 ( Other Identifier: CTEP )
P30CA046592 ( U.S. NIH Grant/Contract )
First Submitted: September 2, 2010
First Posted: September 6, 2010
Results First Submitted: September 9, 2015
Results First Posted: October 7, 2015
Last Update Posted: August 7, 2017