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Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy

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: NCT00939523
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : January 13, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Odelia Cooper, Cedars-Sinai Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pituitary Adenomas
Prolactinomas
Intervention Drug: Lapatinib
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lapatinib
Hide Arm/Group Description

All participants will be asked to take Lapatinib 1250 mg po daily for a total of six months during the research study.

Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study.

Period Title: Overall Study
Started 9
Completed 6
Not Completed 3
Reason Not Completed
Lack of Efficacy             1
Physician Decision             2
Arm/Group Title Lapatinib
Hide Arm/Group Description

All participants will be asked to take Lapatinib daily for a total of six months during the research study.

Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study.

Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
41.2  (18.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
7
  77.8%
Male
2
  22.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Hispanic or Latino
3
  33.3%
Not Hispanic or Latino
6
  66.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  11.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  11.1%
White
7
  77.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
 100.0%
Prolactin  
Mean (Standard Deviation)
Unit of measure:  Ng/ml
Number Analyzed 9 participants
2367  (4617)
1.Primary Outcome
Title Change in Tumor Volume
Hide Description Tumor volume will be assessed on MRI at 6 months on therapy and compared to baseline MRI.
Time Frame baseline and at 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Note: 1 subject was withdrawn after 6 weeks of lapatinib therapy and therefore not included in analysis. A 2nd subject was not included in this analysis as the drug was given on compassionate basis to prevent recurrence of her tumor. She had a negative baseline MRI and maintained a negative MRI at study end.
Arm/Group Title Lapatinib
Hide Arm/Group Description:

All participants will be asked to take Lapatinib 1250 mg po daily for a total of six months during the research study.

Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study.

Overall Number of Participants Analyzed 7
Median (Full Range)
Unit of Measure: Percent volume
10
(-41.4 to 318)
2.Primary Outcome
Title Number of Participants With 50% Reduction in Prolactin Levels
Hide Description 50% reduction in prolactin level measured monthly on 6 months therapy compared to baseline level.
Time Frame every month, up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 6 prolactinomas and 3 nonfunctioning tumors in this trial. Prolactin results are only reported for the prolactinomas.
Arm/Group Title Lapatinib
Hide Arm/Group Description:

All participants will be asked to take Lapatinib 1250 mg po daily for a total of six months during the research study.

Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study.

Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
1
  16.7%
3.Secondary Outcome
Title % Change in Prolactin From Baseline to Study End
Hide Description Percent prolactin change from start of lapatinib to end of study participant participation
Time Frame Baseline and at 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Prolactin results only reported on the 6 prolactinomas in the trial and not for the nonfunctioning tumors.
Arm/Group Title Lapatinib
Hide Arm/Group Description:

All participants will be asked to take Lapatinib 1250 mg po daily for a total of six months during the research study.

Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study.

Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: percent change in prolactin
-7.0
(-78.5 to 103.0)
4.Secondary Outcome
Title ErbB Receptor Expression
Hide Description Mean percent positive expression of EGFR and ErbB2 will be tested on pathologic tumor specimens from subjects treated with lapatinib
Time Frame at 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of the subjects who participated in the trial, only 3 had available tumor tissue to immunostain. Therefore, results could not be reported on the other subjects.
Arm/Group Title Lapatinib
Hide Arm/Group Description:

All participants will be asked to take Lapatinib 1250 mg po daily for a total of six months during the research study.

Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study.

Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: percent positive expression
0  (0)
Time Frame Adverse event data were collected over 6 months
Adverse Event Reporting Description Prior to initiating therapy, patients were assessed with monthly echocardiogram,ECG, physical examinations, chemistry and hematology panels. Adverse events were graded by the NCI-CTC. Subjects with toxicity equal to Grade 3 on the NCI-CTC will have their dose held and resumed at a fifty percent dose reduction when the toxicity has resolved. Those subjects with toxicity equal to Grade 4 were discontinued on the study drug.
 
Arm/Group Title Lapatinib
Hide Arm/Group Description

All participants will be asked to take Lapatinib 1250 mg po daily for a total of six months during the research study.

Lapatinib: All participants will be asked to take Lapatinib daily for six months during the research study.

All-Cause Mortality
Lapatinib
Affected / at Risk (%)
Total   0/9 (0.00%) 
Hide Serious Adverse Events
Lapatinib
Affected / at Risk (%)
Total   1/9 (11.11%) 
Hepatobiliary disorders   
Transaminitis   1/9 (11.11%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lapatinib
Affected / at Risk (%)
Total   8/9 (88.89%) 
Cardiac disorders   
Bradycardia   3/9 (33.33%) 
Gastrointestinal disorders   
Diarrhea   2/9 (22.22%) 
Hepatobiliary disorders   
Transaminitis   2/9 (22.22%) 
Skin and subcutaneous tissue disorders   
Rash  [1]  5/9 (55.56%) 
Indicates events were collected by systematic assessment
[1]
Acneiform rash noted in 5 subjects
For one of the secondary outcomes, the ErbB receptor expression, only 3 subjects had tumor specimens available to immunostain. Therefore, only results on 3 subjects were reported for this outcome.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Odelia Cooper
Organization: Cedars-Sinai Medical Center
Phone: 310-423-4774
EMail: coopero@cshs.org
Layout table for additonal information
Responsible Party: Odelia Cooper, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00939523    
Other Study ID Numbers: 18129
First Submitted: July 14, 2009
First Posted: July 15, 2009
Results First Submitted: November 18, 2019
Results First Posted: January 13, 2020
Last Update Posted: January 22, 2020