Phase III, multicentre, open study to assess the efficacy and safety profiles of the co-administration of lanreotide Autogel 120 mg (administered via deep subcutaneous injections every 28 days) and pegvisomant 40 to 120 mg per week (administered via subcutaneous route once or twice a week) in acromegalic patients failing to respond to lanreotide Autogel 120 mg

Phase III, multicentre, open study to assess the efficacy and safety profiles of the co-administration of lanreotide Autogel 120 mg (administered via deep subcutaneous injections every 28 days) and pegvisomant 40 to 120 mg per week (administered via subcutaneous route once or twice a week) in acromegalic patients failing to respond to lanreotide Autogel 120 mg - Study 727 Combi

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30806

Enrollment

Registered

2006-07-25

Start date

2007-03-22

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly Gigantism

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Male or female aged between 18 and 75 years inclusive. 2. The patient must have had documentation supporting the diagnosis of acromegaly, including elevated GH and/or IGF-1 levels. 3. The patient is treated with pegvisomant, because of IGF-1 level remaining above ULN when treated with somatostatin analogue, on a daily basis for at least 3 months and has normal (age and sex adjusted) IGF-1 level, or IGF-1 level above ULN after treatment with pegvisomant 30 mg per day, OR the patient is treated with lanreotide Autogel or octreotide LAR for at least 6 months including the last 3 months at the highest marketed dose, and has a serum IGF-1 level above ULN, 28 days after the last injection. AT THE END OF THE RUN-IN PERIOD 4. The patient has a serum IGF-1 level above 1.2 x ULN, or a serum IGF-1 level between ULN and 1.2 x ULN and a serum GH nadir > 1 µg/L (assessed by an OGTT), 28 days after the 3rd injection of lanreotide Autogel 120 mg. 5. The patient is diabetic and has a serum IGF-1 level above 1.2 x ULN, 28 days after the 3rd injection of lanreotide Autogel 120 mg.

Exclusion criteria

Exclusion criteria: 1. The patient has undergone pituitary surgery or radiotherapy within 6 months prior to study entry. 2. It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study. 3. The patient has a history of hypersensitivity to lanreotide or pegvisomant or drugs with a similar chemical structure. 4.The patient has already been treated with a somatostatin analogue associated with a GH antagonist. 5. The patient has received a dopamine agonist within 6 weeks prior to study entry. 6.The patient has abnormal hepatic function at study entry (defined as AST, ALT, GGT, AP, PT or total bilirubin above 2 x ULN).

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period.	—

Secondary

Measure	Time frame
Secondary efficacy endpoints will be: -Serum IGF-1 levels, at each assessment. - Number and percentage of patients with normalised (age and sex adjusted) IGF-1 levels, at each assessment. - Acromegaly symptoms. All these endpoints will be assessed before stopping previous treatment (visit V1), before the run-in period (visit V2), at visit V3, and during the co-treatment period 4 weeks after the dose adaptation of pegvisomant (visits V5, V7, V9) and V11. - Quality of life assessed at visits V2, V3 and V11.	—

Measure

Time frame

Secondary efficacy endpoints will be: -Serum IGF-1 levels, at each assessment. - Number and percentage of patients with normalised (age and sex adjusted) IGF-1 levels, at each assessment. - Acromegaly symptoms. All these endpoints will be assessed before stopping previous treatment (visit V1), before the run-in period (visit V2), at visit V3, and during the co-treatment period 4 weeks after the dose adaptation of pegvisomant (visits V5, V7, V9) and V11. - Quality of life assessed at visits V2, V3 and V11.

—

Countries

Netherlands

Outcome results