A multicenter, single arm, proof of concept study to investigate in a first stage the efficacy of a combination therapy of Sandostatin® LAR® and Cabergoline, optionally followed by a combination of Sandostatin® LAR® and pegvisomant, in acromegalic patients only partially responsive to somatostatin analog monotherapy - PHOENIX

• Conditions: acromegaly; MedDRA version: M15Level: LLTClassification code 10000599

• Registration Number: EUCTR2005-002919-24-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-20
• Last Update Posted: 10 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Male or female patients aged 18 years or older.
2.Patients with prior surgery of micro- or macroadenoma of the pituitary.
3.At least 6 months chronic treatment with somatostatin analogues abd the last 3 months treated with the highest dose of somatostatin analogues.

5.Lack of suppression of GH nadir to < 1.0 mcg/l, after oral administration of 75 g of glucose (OGTT) and IGF-I levels at least 10% above the normal value ± 2 SD must be proven within 4 weeks prior to visit 1.
However, if acromegaly symptoms are inadequately controlled as defined in the acromegaly comorbidities and symptom evaluation (as judged by the investigator), an abnormal GH or IGF-1-value as defined above is sufficient.
6.Patient’s written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass.
2.Radiotherapy planned or radiotherapy for acromegaly within the last 2 years.
3.Symptomatic cholelithiasis that is clinically relevant.
4.Psychose in anamnesis.
5.Severe cardiovascular dysfunction (for example cardiomyopathy, congestive heart failure NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, fibrosis of heart valvila and lung.
6.Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or persistent ALT, AST, alkaline phosphatase 2 x > upper limit of normal, or total bilirubin 1.5 x > upper limit of normal.
7. Any medical conditions contraindicated in the SPC of all study drugs.
8.Abnormal clinical laboratory values considered by the Investigator to be clinically significant and which could affect the interpretation of the study results.
9.Any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator.
10. Patients with a complete resistence to somatostatin analogues therapy.
11.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml).
12. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.
13. Receiving treatment with dopamine agonists within the last 6 months.
14. Prior treatment with GH-receptor-antagonists.
15. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half lives of enrollment, whichever is longer.
16. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
17. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
18. Unable to complete the entire study for any reason.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified