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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00939523
• Date of registration: 14/07/2009
• Prospective Registration: No
• Primary sponsor: Cedars-Sinai Medical Center
• Public title: Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy
• Scientific title: Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy
• Date of first enrolment: July 2009
• Target sample size: 9
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00939523
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Odelia Cooper, MD
• Affiliation: Cedars-Sinai Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with nonfunctioning adenomas who have undergone at least one prior surgical
resection and have demonstrated recurrence on MRI

- Patients with prolactinomas who are resistant to dopamine agonist therapy

- Patients with malignant pituitary tumors

- Patients with visual field deficits and/or compression of the optic chiasm must be
stable for at least 6 months

Exclusion Criteria:

- Patients with compromised visual fields and/or compression of the optic chiasm on MRI
that has not been stable for last 6 months.

- Patients that have reduced left ventricular ejection fraction less than 50%

- Patients with moderate to severe hepatic impairment

- Patients that are pregnant or lactating

- Patients under the age of 18

- Active hepatitis

- Known previous HIV Positive

- Concurrent cancers

- Life expectancy less than one year



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Prolactinomas

Pituitary Adenomas

Intervention(s)

Drug: Lapatinib

Primary Outcome(s)

Change in Tumor Volume [Time Frame: baseline and at 6 months]

Number of Participants With 50% Reduction in Prolactin Levels [Time Frame: every month, up to 6 months]

Secondary Outcome(s)

ErbB Receptor Expression [Time Frame: at 6 months]

% Change in Prolactin From Baseline to Study End [Time Frame: Baseline and at 6 months]

Secondary ID(s)

18129

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00939523