CAM2029 for Acromegaly

Recruiting in Palo Alto (17 mi)

+68 other locations

Overseen byDiego Ferone, Dr

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Camurus AB

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing the long-term safety and effectiveness of CAM2029, an injection given regularly, in patients with acromegaly. The medication helps to manage symptoms by reducing growth hormone levels. Patients from a previous related trial can continue treatment, and those completing the main trial can extend their treatment for an additional period.

Research Team

Diego Ferone, Dr

Principal Investigator

University of Genova Endocrinology Unit

Eligibility Criteria

Adults diagnosed with acromegaly who have been on a stable dose of octreotide LAR or lanreotide ATG for at least 3 months can join. They must have certain levels of IGF-1, good organ function, and a normal ECG. People who've had recent surgery, uncontrolled diabetes, or used specific acromegaly treatments recently cannot participate.

Inclusion Criteria

I have been diagnosed with acromegaly.

I have been on a stable dose of octreotide or lanreotide for at least 3 months.

Your IGF-1 levels are too high or too low.

See 4 more

Exclusion Criteria

I have not had major surgery in the last month.

I need surgery for vision problems due to pressure on my optic nerve.

I had pituitary surgery within the last 6 months.

See 6 more

Treatment Details

Interventions

CAM2029 (Somatostatin Analog)

Trial OverviewThe trial is testing the long-term safety and effectiveness of CAM2029 (octreotide subcutaneous depot) in treating acromegaly. Participants will receive monthly injections for up to one year. Those from an earlier trial may continue treatment here.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: CAM2029 (octreotide subcutaneous depot)Experimental Treatment1 Intervention

CAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, 12 months treatment with an option of extension. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available.