Overview

This trial is active, not recruiting.

Condition acromegaly
Treatments pasireotide (som230), octreotide lar 30mg, lanreotide atg 120mg
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date July 2010
End date January 2013
Trial size 190 participants
Trial identifier NCT01137682, 2009-016722-13, CSOM230C2402, EUDRACT 2009-016722-13

Summary

This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
pasireotide (som230)
Double-blind pasireotide LAR 40 mg i.m. injection once every 28 ± 2 days for 24 weeks or Double-blind pasireotide LAR 60 mg i.m. injection once every 28 ± 2 days for 24 weeks
(Experimental)
Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
pasireotide (som230)
Double-blind pasireotide LAR 40 mg i.m. injection once every 28 ± 2 days for 24 weeks or Double-blind pasireotide LAR 60 mg i.m. injection once every 28 ± 2 days for 24 weeks
(Active Comparator)
If a patient is randomized to the open label arm the investigator will either: be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
octreotide lar 30mg
In an open-label, active control arm, continue on the same treatment with octreotide LAR 30 mg every 28 ± 2 days as received for at least 6 months prior to randomization
lanreotide atg 120mg
In an open-label, active control arm, continue on the same treatment with lanreotide ATG 120 mg every 28 ± 2 days as received for at least 6 months prior to randomization

Primary Outcomes

Measure
Measure the mean Growth Hormone (GH) levels and Insulin-like Growth Factor (IGF-1) levels at 24 weeks
time frame: 24 weeks

Secondary Outcomes

Measure
Measure the mean GH levels and IGF-1 levels at 12 weeks
time frame: 12 weeks
Measure the tumor volume reduction assessed by pituitary MRI at 24 weeks
time frame: 24 weeks
Measure the IGF-1 level alone at 24 weeks
time frame: 24 weeks
Measure the overall safety and tolerability of pasirotide LAR 40 mg and pasireotide LAR 60 mg
time frame: 24 weeks
Measure the health-related quality of life using the AcroQoL instrument
time frame: 24 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patients with written informed consent prior to any study related activity 2. Patients with inadequately controlled acromegaly as defined by a mean GH concentration of a 5-point profile over a 2-hour period > 2.5 µg/L and sex- and age-adjusted IGF-1 > 1.3 x upper limit of normal (ULN) 3. Patients treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to visit 1 (screening). The maximum indicated dose for octreotide LAR is 30mg and for lanreotide ATG is 120 mg 4. Patients with diagnosis of pituitary micro- or macro adenoma. Patients can have been previously submitted to surgery Exclusion Criteria: 1. Patients who have received pasireotide (SOM 230) prior to enrolment 2. Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to visit 1 (screening)(8 weeks wash out period). Such patients must have been treated with octreotide LAR 30 mg or lanreotide ATG 120 mg monotherapy continuously for a minimum of 6 months prior to starting combination therapy and they should have been inadequately controlled on monotherapy. 3. Patients with compression of the optic chiasm causing acute clinically significant visual field defects 4. Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression 5. Patients who have received pituitary irradiation within 10 years prior to visit 1 (screening). 6. Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks prior to visit 1 (screening). 7. Patients who are hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy Other protocol-defined inclusion/exclusion criteria may apply

Additional Information

Official title A Phase III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acromegaly
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Novartis.