A Study of Pasireotide in People With Prolactinoma

Conditions

• Prolactin-Producing Pituitary Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pasireotide — DRUG
  Pasireotide will be initiated at 40 mg IM one time dose and if tolerated dose will be increased to 60 mg IM every 4 weeks +/-7 days.
• SF-36 and HADS — OTHER
  Baseline assessment will be conducted within 30 days of starting treatment, week 12, 24 and week 28.

Study Details

The researchers are doing this study to find out whether pasireotide is an effective treatment for people with prolactinoma who cannot receive dopamine agonist therapy. Another purpose of this study is to find out whether pasireotide is a safe treatment for people with prolactinoma.

Key Dates

Start date

Feb 27, 2024

Status verified

Mar 2026

Primary completion

Feb 28, 2027

Completion

Feb 28, 2027

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Pasireotide
  All patients will initiate open-label treatment with pasireotide LAR on week 1 in the outpatient setting. Pasireotide will be initiated at 40 mg IM one time dose and if tolerated dose will be increased to 60 mg IM every 4 weeks +/-7 days. Additional dose adjustments will be allowed as per PI judgement, based on response and tolerability. Administration of pasireotide will align with package inset. Patients must return to the study center every 28 days (+/- 7 days) to receive study medication and for evaluation.

Primary Outcome Measure

biochemical response rate [ Time Frame: within 24 weeks of treatment ]

Central Contacts

• Eliza Geer, MD
  646-608-3797
  [email protected]
• Andrew Lin, MD
  212-639-8392

Locations (7)

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