Trial Outcomes & Findings for Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy (NCT NCT00939523)

NCT ID: NCT00939523

Last Updated: 2020-01-22

Results Overview

Tumor volume will be assessed on MRI at 6 months on therapy and compared to baseline MRI.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: baseline and at 6 months
• Results posted on: 2020-01-22

Participant Flow

Participant milestones

Measure	Lapatinib 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 Study STARTED	9
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Lapatinib 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 Study Lack of Efficacy	1
Overall Study Physician Decision	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Lapatinib n=9 Participants 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.
Age, Continuous	41.2 years STANDARD_DEVIATION 18.6 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants
Prolactin	2367 ng/ml STANDARD_DEVIATION 4617 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and at 6 months

Population: 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.

Tumor volume will be assessed on MRI at 6 months on therapy and compared to baseline MRI.

Outcome measures

Measure	Lapatinib n=7 Participants 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.
Change in Tumor Volume	10 Percent volume Interval -41.4 to 318.0

PRIMARY outcome

Timeframe: every month, up to 6 months

Population: There were 6 prolactinomas and 3 nonfunctioning tumors in this trial. Prolactin results are only reported for the prolactinomas.

50% reduction in prolactin level measured monthly on 6 months therapy compared to baseline level.

Outcome measures

Measure	Lapatinib n=6 Participants 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.
Number of Participants With 50% Reduction in Prolactin Levels	1 Participants

SECONDARY outcome

Timeframe: Baseline and at 6 months

Population: Prolactin results only reported on the 6 prolactinomas in the trial and not for the nonfunctioning tumors.

Percent prolactin change from start of lapatinib to end of study participant participation

Outcome measures

Measure	Lapatinib n=6 Participants 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.
% Change in Prolactin From Baseline to Study End	-7.0 percent change in prolactin Interval -78.5 to 103.0

SECONDARY outcome

Timeframe: at 6 months

Population: 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.

Mean percent positive expression of EGFR and ErbB2 will be tested on pathologic tumor specimens from subjects treated with lapatinib

Outcome measures

Measure	Lapatinib n=3 Participants 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.
ErbB Receptor Expression	0 percent positive expression Standard Deviation 0

Adverse Events

Lapatinib

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure

Lapatinib n=9 participants at risk 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.

Hepatobiliary disorders Transaminitis

11.1% 1/9 • Adverse event data were collected over 6 months 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.

Other adverse events

Measure	Lapatinib n=9 participants at risk 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.
Skin and subcutaneous tissue disorders Rash	55.6% 5/9 • Adverse event data were collected over 6 months 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.
Gastrointestinal disorders Diarrhea	22.2% 2/9 • Adverse event data were collected over 6 months 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.
Cardiac disorders Bradycardia	33.3% 3/9 • Adverse event data were collected over 6 months 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.
Hepatobiliary disorders Transaminitis	22.2% 2/9 • Adverse event data were collected over 6 months 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.

Additional Information

Odelia Cooper

Cedars-Sinai Medical Center

Phone: 310-423-4774

Email: coopero@cshs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place