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Trial record 36 of 479 for:    colon cancer | ( Map: Texas, United States )

AZD0530 (NSC 735464) in Treating Patients With Previously Treated Metastatic Colon Cancer or Rectal Cancer

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ClinicalTrials.gov Identifier: NCT00397878
Recruitment Status : Terminated (The study was terminated after all enrolled participants progressed.)
First Posted : November 10, 2006
Results First Posted : February 6, 2014
Last Update Posted : August 20, 2019
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 Adenocarcinoma of the Colon
Adenocarcinoma of the Rectum
Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IV Colon Cancer
Stage IV Rectal Cancer
Interventions Drug: saracatinib
Other: laboratory biomarker analysis
Enrollment 10
Recruitment Details Recruitment Period: November 16, 2006 to April 08, 2008. Recruitment done at University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Treatment (Saracatinib)
Hide Arm/Group Description Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Treatment (Saracatinib)
Hide Arm/Group Description Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
60
(46 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Median Progression Free Survival (PFS)
Hide Description Time period of metastatic colorectal patients with one previous chemotherapy treatment for metastatic disease who are alive and progression free after commencing the experimental therapy. A 95% posterior credible intervals used.
Time Frame Time from start of treatment to time of progression, up to 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Saracatinib)
Hide Arm/Group Description:
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: weeks
7.9
(2.1 to 9.6)
2.Secondary Outcome
Title Overall Survival
Hide Description Number of participants who survived up to 5 years
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Saracatinib)
Hide Arm/Group Description:
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
6
  60.0%
3.Secondary Outcome
Title Time to Progression
Hide Description Number of participants who progressed on treatment within less than or equal to 2 cycles (cycle=28 days; within 54 days PD).
Time Frame within 54 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Saracatinib)
Hide Arm/Group Description:
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
4.Other Pre-specified Outcome
Title Pre- and Post-treatment Expression Values for Each Biological Correlate
Hide Description Statistical significance of the associations assessed using a nonparametric Sign Test performed on the difference of the post-treatment and pre-treatment values. A two-sided .05 significance level to be used.
Time Frame Up to 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No patients consented to optional tissue analysis.
Arm/Group Title Treatment (Saracatinib)
Hide Arm/Group Description:
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Saracatinib)
Hide Arm/Group Description Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Treatment (Saracatinib)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Saracatinib)
Affected / at Risk (%) # Events
Total   9/10 (90.00%)    
Blood and lymphatic system disorders   
Lymphocyte count decreased  1  1/10 (10.00%)  1
White blood cell decreased  1  1/10 (10.00%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/10 (10.00%)  1
Dehydration  1  1/10 (10.00%)  1
Nausea  1  2/10 (20.00%)  2
Small intestinal perforation  1  1/10 (10.00%)  1
General disorders   
Death NOS  1  6/10 (60.00%)  10
Fatigue  1  1/10 (10.00%)  1
Infections and infestations   
Sepsis  1  1/10 (10.00%)  1
Metabolism and nutrition disorders   
Blood bilirubin increased  1  1/10 (10.00%)  1
Hypoalbuminemia  1  1/10 (10.00%)  1
Hypocalcemia  1  1/10 (10.00%)  1
Hyponatremia  1  2/10 (20.00%)  3
Hypophosphatemia  1  4/10 (40.00%)  6
Musculoskeletal and connective tissue disorders   
Fibrosis deep connective tissue  1  1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Lung Infection  1  1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Saracatinib)
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  9/10 (90.00%)  12
Lymphocyte count decreased  1  1/10 (10.00%)  2
Neutrophil count decreased  1  1/10 (10.00%)  1
Platelet count decreased  1  4/10 (40.00%)  4
White blood cell decreased  1  1/10 (10.00%)  3
Cardiac disorders   
Hypertension  1  3/10 (30.00%)  3
Endocrine disorders   
Hypothyroidism  1  1/10 (10.00%)  1
Eye disorders   
Watering eyes  1  2/10 (20.00%)  2
Gastrointestinal disorders   
Anorexia  1  5/10 (50.00%)  5
Diarrhea  1  5/10 (50.00%)  6
Abdominal distension  1 [1]  2/10 (20.00%)  2
Abdominal pain  1  6/10 (60.00%)  6
Constipation  1  5/10 (50.00%)  8
Flatulence  1  1/10 (10.00%)  2
Gastritis  1  2/10 (20.00%)  2
Hemorrhoidal hemorrhage  1  1/10 (10.00%)  1
Mucositis oral  1  1/10 (10.00%)  1
Nausea  1  5/10 (50.00%)  8
Proctitis  1  1/10 (10.00%)  1
Rectal hemorrhage  1  1/10 (10.00%)  1
Vomiting  1  3/10 (30.00%)  6
General disorders   
Fatigue  1  10/10 (100.00%)  16
Fever  1  3/10 (30.00%)  3
Headache  1  1/10 (10.00%)  1
Tumor pain  1  2/10 (20.00%)  2
Weight loss  1  2/10 (20.00%)  2
Hepatobiliary disorders   
Alanine aminotransferase increased  1  1/10 (10.00%)  1
Aspartate aminotransferase increased  1  6/10 (60.00%)  7
Blood bilirubin increased  1  3/10 (30.00%)  3
Immune system disorders   
Immune system disorders  1 [2]  2/10 (20.00%)  2
Infections and infestations   
Urinatry Tract Infections  1  5/10 (50.00%)  6
Elevated Blood Counts (Investigations)  1 [3]  5/10 (50.00%)  6
Metabolism and nutrition disorders   
Alkaline phosphatase increased  1  8/10 (80.00%)  12
Acidosis  1  1/10 (10.00%)  1
Cholesterol high  1  3/10 (30.00%)  3
Creatine phosphokinase (CPK) increased  1  1/10 (10.00%)  1
Creatinine increased  1  2/10 (20.00%)  2
Hemoglobinuria  1  1/10 (10.00%)  1
Hyperglycemia  1  7/10 (70.00%)  8
Hyperkalemia  1  3/10 (30.00%)  4
Hyperuricemia  1  1/10 (10.00%)  1
Hypoalbuminemia  1  2/10 (20.00%)  3
Hypocalcemia  1  3/10 (30.00%)  3
Hypokalemia  1  1/10 (10.00%)  1
Hyponatremia  1  2/10 (20.00%)  5
Hypophosphatemia  1  6/10 (60.00%)  11
Proteinuria  1  5/10 (50.00%)  5
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/10 (20.00%)  2
Back Pain  1  2/10 (20.00%)  2
Extraocular muscle paresis  1  1/10 (10.00%)  1
Myalgia  1  2/10 (20.00%)  2
Pain  1  1/10 (10.00%)  1
Nervous system disorders   
Peripheral sensory neuropathy  1  7/10 (70.00%)  7
Psychiatric disorders   
Anxiety  1  2/10 (20.00%)  2
Depression  1  2/10 (20.00%)  2
Insomnia  1  2/10 (20.00%)  2
Renal and urinary disorders   
Urinary frequency/retention  1  2/10 (20.00%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/10 (10.00%)  2
Epistaxis  1  1/10 (10.00%)  1
Pleural effusion  1  1/10 (10.00%)  1
Repiratory, Running Nose  1  1/10 (10.00%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  2/10 (20.00%)  2
Nail loss  1  2/10 (20.00%)  2
Palmar-plantar erythrodysesthesia syndrome  1  1/10 (10.00%)  1
Rash acneiform  1  3/10 (30.00%)  5
Skin hyperpigmentation  1  1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Ascites
[2]
Seasonal allergies
[3]
LOW CHLORIDE, ELEVATED Blood urea nitrogen (BUN), ELEVATED URIC ACID, ELEVATED lactate dehydrogenase (LDH) and URINE KETONES
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
Layout table for Results Point of Contact information
Name/Title: Cathy Eng, MD / Professor
Organization: University of Texas MD Anderson Cancer Center
Phone: 713-792-2828
EMail: ceng@mdanderson.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00397878     History of Changes
Other Study ID Numbers: NCI-2013-00067
NCI-2013-00067 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000512970
MDA-2005-0977
NCI-7569
2005-0977 ( Other Identifier: M D Anderson Cancer Center )
7565 ( Other Identifier: CTEP )
N01CM62202 ( U.S. NIH Grant/Contract )
P30CA016672 ( U.S. NIH Grant/Contract )
First Submitted: November 9, 2006
First Posted: November 10, 2006
Results First Submitted: December 17, 2013
Results First Posted: February 6, 2014
Last Update Posted: August 20, 2019