Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy (NRR)

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. Identifier: NCT00246753
Recruitment Status : Completed
First Posted : October 31, 2005
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: lapatinib ditosylate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Men with castration-resistant prostate cancer were recruited from 3 local institutions from 11/11/2005 to 8/29/2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 35 patients initially recruited, 4 were not eligible. One patient was removed in order to receive more aggressive treatment and another patient was removed due to disease progression or death prior to protocol therapy. 29 patients were enrolled.

Reporting Groups
Single Arm Trial

Single Arm Trial

lapatinib ditosylate: 1500 mg, daily until disease progression

Participant Flow:   Overall Study
    Single Arm Trial
Withdrawal by Subject                2 
Physician Decision                2 
Adverse Event                2 
Unacceptable toxicity                2 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Single Arm Trial

Single Arm Trial

lapatinib ditosylate: 1500 mg, daily until disease progression

Baseline Measures
   Single Arm Trial 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (58 to 90) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      0   0.0% 
Male      29 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      3  10.3% 
White      26  89.7% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
United States   29 
PSA [1] 
[Units: ng/mL]
Median (Full Range)
 (4.5 to 196.5) 
[1] Prostate-specific antigen, or PSA, is a protein produced by cells of the prostate gland. The PSA test measures the level of PSA in an individual's blood.The results are usually reported as nanograms of PSA per (ng/mL) of blood. In this study PSA response is defined as >50% decrease in PSA from baseline for 2 successive measurements at lease 4 weeks apart.
Alkaline phosphatase [1] 
[Units: U/L]
Median (Full Range)
 (55 to 110) 
[1] Alkaline phosphatase (ALP) is an enzyme found in your bloodstream. ALP helps break down proteins in the body and exists in different forms, depending on where it originates. Normal range is 44 to 147 U/L ( units per liter)
Hemoglobin [1] 
[Units: Grams per deciliter]
Median (Full Range)
 (11 to 14.7) 
[1] Hemoglobin is a component of red blood cells. The normal level is around 15 grams per deciliter (g/dl) and lower levels in men with prostate cancer indicate a worse prognosis.
Disease Status [1] 
[Units: Participants]
Count of Participants
Bone metastases only      8  27.6% 
Measurable disease only      7  24.1% 
Both bone and measureable disease      7  24.1% 
No metastasis      7  24.1% 
[1] Metastasis is the development of secondary malignant growths at a distance from a primary site of cancer. Measurable disease is the presence of at least one measurable lesion. This is based on RECIST criteria. Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that defines the status of cancer in a patient. Looking at when tumors improve, stay the same, or worsen.

  Outcome Measures

1.  Primary:   Number of Patients Experiencing Decline in Prostate-specific Antigen   [ Time Frame: 4 years ]

2.  Secondary:   Time to Prostate-Specific Antigen (PSA) Progression   [ Time Frame: 4 years ]

3.  Secondary:   Predictive Molecular Markers of Response to Treatment With Lapatinib (GW572016)   [ Time Frame: 4 years ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Robin V. Johnson
Organization: UNC Lineberger Comprehensive Cancer Center
phone: 919-966-1125

Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT00246753     History of Changes
Other Study ID Numbers: LCCC 0505
CDR0000550151 ( Other Identifier: PDQ number )
First Submitted: October 28, 2005
First Posted: October 31, 2005
Results First Submitted: March 8, 2017
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017