AcromegalyPhase 3NCT00642421
Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients
A Phase 3 study testing C2L-OCT-01 PR, 10 or 20 mg and C2L-OCT-01 PR, 20 mg in people with Acromegaly, run by Ambrilia Biopharma, Inc. at 10 sites in 6 countries.
Trial summary
The purpose of this study is to assess the safety profile of a new prolonged release formulation of octreotide acetate, C2L-OCT-01 PR, administered intra muscularly every 4, 5 or 6 weeks in acromegalic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- C2L-OCT-01 PR, 10 or 20 mg and C2L-OCT-01 PR, 20 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 10 sitesin 6 countries
- Study dates
- Feb 2008to Aug 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- To be eligible for entry in this study, patient must NOT:
- If female, be pregnant or lactating.
- Have been treated with a GH receptor antagonist (pegvisomant) within the last 12 weeks.
- Have used a dopamine agonist within the last 30 days.
- Have undergone pituitary surgery within the last 12 weeks.
- Have undergone radiotherapy within the last two years.
Show all 16Show fewer
- Have any contraindication (hypersensitivity to octreotide formulation) or non-responders to Sandostatin-LAR® treatment.
- Be currently treated with Sandostatin-LAR® and have symptoms of acromegaly that would justify, in the Investigator's opinion, a dose modification.
- Be receiving Sandostatin-LAR® administration every < 21 or > 35 days.
- Have a liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or has persistent ALT, AST > 2 X ULN, serum creatinine > 2 X ULN, serum bilirubin > 2 X ULN.
- Have any other conditions that could result in altered GH or IGF-1 levels (such as anorexia nervosa, Laron's syndrome, treatment with levodopa or narcotics analgesics, heroin abuse.)
- Have type I diabetes (insulin-dependent) or uncontrolled type II diabetes (non-insulin-dependent) as indicated by the presence of ketoacidosis or HbA1C greater than or equal to 10%.
- Have clinically significant signs and symptoms potentially related to a tumor compression of the optical chiasm, based on judgment of the investigator.
- Have symptomatic cholelithiasis.
- Have received an investigational drug or participated in a clinical trial within the last 30 days.
- Have clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy.
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
United States5 sites
Kaleida Health/Diabetes Center of WNY
Buffalo, New York, 14206
The Cleveland Clinic
Cleveland, Ohio, 44195
UCLA Medical Center Division of Neurosurgery
Los Angeles, California, 90095
Stanford University Medical Center
Stanford, California, 94305-5826
VA Puget Sound Health Care System
Tacoma, Washington, 98489
Belarus1 site
Republican Centre for Medical Rehabilitation and Water-therapy
Minsk
Ukraine1 site
V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine
Kiev
About this study
Official title: Safety and Biological Activity of a New Prolonged Release Formulation of Octreotide Acetate, C2l-OCT-01 PR, Administered Intra Muscularly Every 4, 5 or 6 Weeks in Acromegalic Patients
The purpose of this study is to assess the safety profile of a new prolonged release formulation of octreotide acetate, C2L-OCT-01 PR, administered intra muscularly every 4, 5 or 6 weeks in acromegalic patients.
- Conditions
- Acromegaly
- Being tested
- C2L-OCT-01 PR, 10 or 20 mg, C2L-OCT-01 PR, 20 mg
- Keywords
- Acromegaly
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C2L-OCT-01 PR, 10 or 20 mgDrug
Also called octreotide acetate
The first three injections of study medication will be given at V1 (Day 1), V2 (35 days) and V3 (70 days). Dose titration and/or injection interval adjustment will be allowed during the Treatment Period should any patients have a mean GH concentration below 1.0 ng/mL or above 2.5 ng/mL. Dose titration (10, 20 or 30 mg) and/or injection interval adjustment (4, 5 or 6 weeks) will be allowed at V3, V6 and V9 based on clinical symptoms and the mean GH concentration determined at V2, V5 and V8.
C2L-OCT-01 PR, 20 mgDrug
Also called octreotide acetate
The first three injections of study medication will be given at V1 (Day 1), V2 (Day 35) and V3 (Day 70). Dose titration and/or injection interval adjustment will be allowed during the Treatment Period should any patients have a mean GH concentration below 1.0 ng/mL or above 2.5 ng/mL. Dose titration (10, 20 or 30 mg) and/or injection interval adjustment (4, 5 or 6 weeks) will be allowed at V3, V6 and V9 based on clinical symptoms and the mean GH concentration determined at V2, V5 and V8.
| Study group | Role | What they receive |
|---|---|---|
| Population A | Experimental | Based on the dose of their previous Sandostatin-LAR treatment, Population A will receive 10 or 20 mg of C2L-OCT-01 PR at 5-week intervals. Receives: Drug: C2L-OCT-01 PR, 10 or 20 mg |
| Population B | Experimental | Population B, naive patients and patients who have stopped their treatment with prolonged release octreotide for at least 12 weeks, will receive 20 mg C2L-OCT-01 PR at 5-week intervals. Receives: Drug: C2L-OCT-01 PR, 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety profile of a new prolonged release formulation of octreotide acetate, C2L-OCT-01 PR, administered intra muscularly every 4, 5 or 6 weeks in acromegalic patients.
Measured: 28-day screening period followed by a 48 to 52 week treatment period and concluding with a end of study visit at 56, 57 or 58 weeks.
Secondary outcomes (4)
To assess biological and clinical activity of C2L-OCT-01 PR by examining the percentage of patients with mean growth hormone (GH) <2.5 ng/ml.
Measured: Screening, Visits 1 through 11, and End of Study Visit.
To assess the biologic and clinical activity of C2L-OCT-01 PR by examining the mean changes from baseline in GH and IGF-1 concentrations.
Measured: Screening, Visits 1 through 11, and End of Study Visit.
To assess the biologic and clinical activity of C2L-OCT-01 PR by examining the acromegaly severity index and patient's health status scores.
Measured: Screening, Visit 1 through 11, and End of Study Visit.
To assess biological and clinical activity of C2L-OCT-01 PR by examining the pituitary tumor size.
Measured: Screening, Visit 6 and End of Study Visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Commercial reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ambrilia Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Raphael Naudin, M.D., Study director, Ambrilia Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642421
- Sponsor's protocol ID
- C2L-OCT-01 PR-303
- Status last verified
- Feb 2010
- First submitted
- 21 Mar 2008
- Last updated
- 9 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Biological Activity of a New Prolonged Release Formulation of Octreotide Acetate, C2l-OCT-01 PR, Administered Intra Muscularly Every 4, 5 or 6 Weeks in Acromegalic Patients
- ClinicalTrials.gov ID
- NCT00642421
- Acronym / sponsor ID
- C2L-OCT-01 PR-303
- Conditions
- Acromegaly
- Keywords
- Acromegaly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Commercial reasons
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ambrilia Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 25 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety profile of a new prolonged release formulation of octreotide acetate, C2L-OCT-01 PR, administered intra muscularly every 4, 5 or 6 weeks in acromegalic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population A | Experimental | Drug: C2L-OCT-01 PR, 10 or 20 mgBased on the dose of their previous Sandostatin-LAR treatment, Population A will receive 10 or 20 mg of C2L-OCT-01 PR at 5-week intervals. |
| Population B | Experimental | Drug: C2L-OCT-01 PR, 20 mgPopulation B, naive patients and patients who have stopped their treatment with prolonged release octreotide for at least 12 weeks, will receive 20 mg C2L-OCT-01 PR at 5-week intervals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- If female, be pregnant or lactating.
- Have been treated with a GH receptor antagonist (pegvisomant) within the last 12 weeks.
- Have used a dopamine agonist within the last 30 days.
- Have undergone pituitary surgery within the last 12 weeks.
- Have undergone radiotherapy within the last two years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C2L-OCT-01 PR, 10 or 20 mgAlso: octreotide acetateThe first three injections of study medication will be given at V1 (Day 1), V2 (35 days) and V3 (70 days). Dose titration and/or injection interval adjustment will be allowed during the Treatment Period should any patients have a mean GH concentration below 1.0 ng/mL or above 2.5 ng/mL. Dose titration (10, 20 or 30 mg) and/or injection interval adjustment (4, 5 or 6 weeks) will be allowed at V3, V6 and V9 based on clinical symptoms and the mean GH concentration determined at V2, V5 and V8. | Drug | Population A |
| C2L-OCT-01 PR, 20 mgAlso: octreotide acetateThe first three injections of study medication will be given at V1 (Day 1), V2 (Day 35) and V3 (Day 70). Dose titration and/or injection interval adjustment will be allowed during the Treatment Period should any patients have a mean GH concentration below 1.0 ng/mL or above 2.5 ng/mL. Dose titration (10, 20 or 30 mg) and/or injection interval adjustment (4, 5 or 6 weeks) will be allowed at V3, V6 and V9 based on clinical symptoms and the mean GH concentration determined at V2, V5 and V8. | Drug | Population B |
Primary outcome
To assess the safety profile of a new prolonged release formulation of octreotide acetate, C2L-OCT-01 PR, administered intra muscularly every 4, 5 or 6 weeks in acromegalic patients.
Time frame: 28-day screening period followed by a 48 to 52 week treatment period and concluding with a end of study visit at 56, 57 or 58 weeks.
4 secondary outcomes
To assess biological and clinical activity of C2L-OCT-01 PR by examining the percentage of patients with mean growth hormone (GH) <2.5 ng/ml.
Time frame: Screening, Visits 1 through 11, and End of Study Visit.
To assess the biologic and clinical activity of C2L-OCT-01 PR by examining the mean changes from baseline in GH and IGF-1 concentrations.
Time frame: Screening, Visits 1 through 11, and End of Study Visit.
To assess the biologic and clinical activity of C2L-OCT-01 PR by examining the acromegaly severity index and patient's health status scores.
Time frame: Screening, Visit 1 through 11, and End of Study Visit.
To assess biological and clinical activity of C2L-OCT-01 PR by examining the pituitary tumor size.
Time frame: Screening, Visit 6 and End of Study Visit.
Results and safety
The study was stopped early (reason given: Commercial reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael Naudin, M.D. study director
Ambrilia Biopharma, Inc.
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing C2L-OCT-01 PR, 10 or 20 mg and C2L-OCT-01 PR, 20 mg in people with Acromegaly, run by Ambrilia Biopharma, Inc. at 10 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Belarus, Hungary, Romania, Serbia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Commercial reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety profile of a new prolonged release formulation of octreotide acetate, C2L-OCT-01 PR, administered intra muscularly every 4, 5 or 6 weeks in acromegalic patients. (time frame: 28-day screening period followed by a 48 to 52 week treatment period and concluding with a end of study visit at 56, 57 or 58 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2010.