The sponsor from our previous Phase I/II acromegaly study selected Pharm-Olam to provide full service on their Phase III study involving 47 sites in Russia, Hungary, USA, Germany, Poland, Czech, Slovakia, Spain, and Serbia.
Enrollment challenges included:
Inclusion criteria required patients with GH below 2.5 ng/ml (full responders to Octreotide treatment)
Patients had to have 3 months on a stable dose of S-LAR before screening. Many acromegaly patients were treated with other available drugs such as Pegvisomant excluding them from participation.
Patients had to be naive to several other standard of care, including: surgery, other medications and radiotherapy.
Investigators reported that some patients did not want to switch from S-LAR, a marketed drug, to an experimental.
4 protocol amendments, (1 from FDA, 3 from sponsor)
Ownership of compound changed during study, requiring changes in all essential documents
In Russia, many acromegaly patients could not afford S-LAR.
To overcome these challenges Pharm-Olam recommended a protocol amendment in Russia allowing patients on stable long term generic octreotide (which had a major impact in that country), opened additional sites, implemented a wider referral system, and travel reimbursement to encourage patients from remote areas.
The initial target was 140 patients, later 164, which were enrolled in 21 months. The sponsor was pleased with our performance and later awarded Pharm-Olam an extension study.