AcromegalyPhase 2NCT01673646
Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism
A Phase 2 study testing Pasireotide LAR in people with Acromegaly and Pituitary Gigantism, run by Novartis Pharmaceuticals at 27 sites in Japan.
Trial summary
To evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide LAR in Japanese patients with active acromegaly or pituitary gigantism. Primary objective was to assess the total-group efficacy of pasireotide LAR on the reduction of mean GH levels to < 2.5 µg/L and the normalization of insulin-like… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly, Pituitary Gigantism
- What is being tested?
- Pasireotide LAR
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 27 sitesJapan
- Study dates
- 16 Oct 2012to 10 Apr 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with medication naïve acromegaly or pituitary gigantism
- Patients with inadequately controlled acromegaly or pituitary gigantism
Who cannot join
- Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1c >8%
- Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
- Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF > 470 ms, hypokalemia, hypomagnesemia, hypocalcemia, family history of long QT syndrome, or patients receiving a concomitant medication known to prolong QT interval
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Japan27 sites
Novartis Investigative Site
Bunkyo Ku, Tokyo, 113 8655
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8603
Novartis Investigative Site
Chiba, 260 8677
Novartis Investigative Site
Fukuoka, Fukuoka, 812-8582
Novartis Investigative Site
Fukushima, Fukushima, 960 1295
Novartis Investigative Site
Isehara, Kanagawa, 259-1193
Novartis Investigative Site
Kagoshima, Kagoshima-ken, 890 8520
Novartis Investigative Site
Kawasaki, Kanagawa, 211-8510
Novartis Investigative Site
Kitakyushu, Fukuoka, 807-8556
Novartis Investigative Site
Kobe, Hyōgo, 650-0017
Novartis Investigative Site
Kyoto, Kyoto, 612-8555
Novartis Investigative Site
Minato Ku, Tokyo, 105-8470
Novartis Investigative Site
Morioka, Iwate, 020 8505
Novartis Investigative Site
Nagoya, Aichi-ken, 466 8560
Novartis Investigative Site
Okayama, Okayama-ken, 700-8558
Novartis Investigative Site
Osaka, Osaka, 530-8480
Novartis Investigative Site
Osaka, 534-0021
Novartis Investigative Site
Sapporo, Hokkaido, 060 8648
Novartis Investigative Site
Sendai, Miyagi, 980 8574
Novartis Investigative Site
Shinjuku Ku, Tokyo, 162 8666
Novartis Investigative Site
Shizuoka, Shizuoka, 420-8527
Novartis Investigative Site
Suita, Osaka, 565 0871
Novartis Investigative Site
tabashi City, Tokyo, 173-8610
Novartis Investigative Site
Tokorozawa, Saitama, 359 8513
Novartis Investigative Site
Toyoake, Aichi-ken, 470 1192
Novartis Investigative Site
Yamagata, 990 9585
Novartis Investigative Site
Yokohama, Kanagawa, 222-0036
About this study
Official title: A Multicenter, Open-label, Randomized, Phase II Study to Evaluate Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Pasireotide LAR in Japanese Patients With Active Acromegaly or Pituitary Gigantism
To evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide LAR in Japanese patients with active acromegaly or pituitary gigantism. Primary objective was to assess the total-group efficacy of pasireotide LAR on the reduction of mean GH levels to < 2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) at 3 months of study treatment.
- Conditions
- Acromegaly, Pituitary Gigantism
- Being tested
- Pasireotide LAR
- Keywords
- SOM230, Pasireotide, acromegaly, Phase II, growth disorder, gigantism, Pituitary adenoma, pituitary gigantism
- Medical subject headings
- Acromegaly, Gigantism, Growth Disorders, Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasireotide LARDrug
Also called SOM230
Intramuscular administration of pasireotide LAR was repeated every month (1 month = 28 days) for 12 months in core phase. It was permitted to increase the dose up to 60 mg in a patient showing the following biochemical test results after 3 and 6 months of study treatment: mean GH levels ≥2.5 µg/L and/or IGF-1 > ULN. In the event of any problem with tolerability, it was permitted to reduce the next lower dosage level at any time.
| Study group | Role | What they receive |
|---|---|---|
| Pasireotide LAR 20mg | Experimental | Enrolled patients were randomized to 20mg pasireotide LAR. Receives: Drug: Pasireotide LAR |
| Pasireotide LAR 40mg | Experimental | Enrolled patients were randomized to 40mg pasireotide LAR. Receives: Drug: Pasireotide LAR |
| Pasireotide LAR 60mg | Experimental | Enrolled patients were randomized to 60mg pasireotide LAR. Receives: Drug: Pasireotide LAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total-group Response Rate at Month 3
Percentage of participants with a reduction of mean growth hormone (GH) levels to < 2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) to within normal limits (age and sex related) at 3 months across all doses
Measured: Month 3
Secondary outcomes (17)
Response Rate at Month 3 by Randomized Dose Level
Percentage of participants with a reduction of mean GH levels to < 2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) at 3 months in each starting dose.
Measured: Month 3
GH Response at Month 3 by Randomized Dose
Percentage of participants with a reduction of mean GH levels to < 2.5 µg/L at 3 months.
Measured: Month 3
IGF-1 Response at Month 3 by Randomized Dose
Percentage of participants with the normalization of IGF-1 to within normal limits (age and sex related) at 3 months.
Measured: Month 3
Total-group Response Rate (GH & IGF-1) Over Time (Core Phase)
Percentage of participants with a reduction of mean GH levels to < 2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) at 3, 6, 9 and 12 months
Measured: Months 3, 6, 9 & 12
Percentage of Overall Participants With the Reduction of GH Levels to <2.5 ug/L by Visit (Core Phase)
This refers to the percentage of participants with a reduction of growth hormone (GH) response rates to <2.5 ug/L over time.
Measured: Months 3, 6, 9, 12
Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core Phase)
This refers to the percentage of participants with the normalization of insulin-like growth factor-1 (IGF-1) to within normal limits by visit.
Measured: Months 3, 6, 9, 12
Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level
Ctrough: The trough level concentration on day 28, 3 months post 1st, 2nd and 3rd injections of Pasireotide LAR.
Cmax: The maximum concentration 3 months post the 1st injection and 3rd injection of LAR.
Measured: Ctrough: Day 28 after each injection 1-3, Cmax: 3 months after injections 1 and 3
Summary of Pasireotide LAR PK Parameter of Accumulation Ratio Randomized Dose Level
The accumulation ratio was calculated as a ratio of (Ctrough day28, 3rd injection/Ctrough day28, 1st injection).
Measured: Day 28 after injections 1 and 3
Change of Tumor Volume From Baseline
This shows the change in tumor volume from baseline to month 6 and from baseline to month 12 in patients treated with pasireotide LAR.
Measured: Baseline, Months 6 , 12
Change in Mean GH Levels From Baseline
This shows the change in mean GH levels from baseline in median GH levels by visit.
Measured: Baseline, Months 2.75, 3, 6, 9, 12, 18, 24
Change in Ring Size From Baseline
Change of clinical signs from baseline: ring size. In Japan, ring sizes are specified using a numerical scale, that only has whole sizes, and does not have simple linear correlation with diameter or circumference. Only numbers are used ranging from 1 to 27. For instance, a ring size of 1 in Japan is equivalent to an inside circumference ring size of 38.86 mm and a ring size of 27 in Japan is equivalent to an inside circumference ring size of 70.15 mm.
Measured: Baseline, Months 3, 6, 9, 12
Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase)
Number of participants with a change of clinical signs from baseline (BL): headache (HA), fatigue (FA), perspiration (PE), paresthesias (PA), osteoarthralgia (OS)
Measured: 12 Months (Core phase)
Change From Baseline in Prolactin
Change in prolactin levels from baseline
Measured: Baseline, Months 3, 6, 9, 12
Total-group Response Rate by Visit (Extension Phase)
Percentage of participants with a reduction of mean GH levels to < 2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) a18 and 24 months of study treatment.
Measured: Months 18, 24
Percentage of Overall Participants With the Reduction of Mean GH Levels to <2.5 ug/L by Visit (Extension Phase)
Percentage of participants with a reduction of mean GH levels to < 2.5µg/L at 18 and 24 months of study treatment
Measured: Months 18, 24
Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Extension Phase)
Percentage of participants with the normalization of IGF-1 to within normal limits (age and sex related) at 18 and 24 months of study. treatment
Measured: Months 18, 24
Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase)
This shows a change of mean GH levels and somatostatin analogues (SSAs) from baseline in extension phase
Measured: Baselnine, Months 2.75, 3, 6, 9, 12, 18, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study start16 Oct 2012
- Primary completion10 Apr 2017
- Study completion10 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673646
- Sponsor's protocol ID
- CSOM230C1202
- Status last verified
- Jul 2019
- First submitted
- 16 Aug 2012
- Last updated
- 16 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized, Phase II Study to Evaluate Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Pasireotide LAR in Japanese Patients With Active Acromegaly or Pituitary Gigantism
- ClinicalTrials.gov ID
- NCT01673646
- Acronym / sponsor ID
- CSOM230C1202
- Conditions
- Acromegaly, Pituitary Gigantism
- Keywords
- SOM230, Pasireotide, acromegaly, Phase II, growth disorder, gigantism, Pituitary adenoma, pituitary gigantism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2012 (actual)
- Primary completion
- 10 Apr 2017 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Posted 16 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide LAR in Japanese patients with active acromegaly or pituitary gigantism. Primary objective was to assess the total-group efficacy of pasireotide LAR on the reduction of mean GH levels to < 2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) at 3 months of study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pasireotide LAR 20mg | Experimental | Drug: Pasireotide LAREnrolled patients were randomized to 20mg pasireotide LAR. |
| Pasireotide LAR 40mg | Experimental | Drug: Pasireotide LAREnrolled patients were randomized to 40mg pasireotide LAR. |
| Pasireotide LAR 60mg | Experimental | Drug: Pasireotide LAREnrolled patients were randomized to 60mg pasireotide LAR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with medication naïve acromegaly or pituitary gigantism
- Patients with inadequately controlled acromegaly or pituitary gigantism
Key exclusion criteria (3 listed)
- Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1c >8%
- Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
- Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF > 470 ms, hypokalemia, hypomagnesemia, hypocalcemia, family history of long QT syndrome, or patients receiving a concomitant medication known to prolong QT interval
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 |
|---|---|---|
| Pasireotide LARAlso: SOM230Intramuscular administration of pasireotide LAR was repeated every month (1 month = 28 days) for 12 months in core phase. It was permitted to increase the dose up to 60 mg in a patient showing the following biochemical test results after 3 and 6 months of study treatment: mean GH levels ≥2.5 µg/L and/or IGF-1 > ULN. In the event of any problem with tolerability, it was permitted to reduce the next lower dosage level at any time. | Drug | Pasireotide LAR 20mg, Pasireotide LAR 40mg, Pasireotide LAR 60mg |
Primary outcome
Total-group Response Rate at Month 3
Time frame: Month 3
Percentage of participants with a reduction of mean growth hormone (GH) levels to < 2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) to within normal limits (age and sex related) at 3 months across all doses
17 secondary outcomes
Response Rate at Month 3 by Randomized Dose Level
Time frame: Month 3
GH Response at Month 3 by Randomized Dose
Time frame: Month 3
IGF-1 Response at Month 3 by Randomized Dose
Time frame: Month 3
Total-group Response Rate (GH & IGF-1) Over Time (Core Phase)
Time frame: Months 3, 6, 9 & 12
Percentage of Overall Participants With the Reduction of GH Levels to <2.5 ug/L by Visit (Core Phase)
Time frame: Months 3, 6, 9, 12
Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core Phase)
Time frame: Months 3, 6, 9, 12
Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level
Time frame: Ctrough: Day 28 after each injection 1-3, Cmax: 3 months after injections 1 and 3
Summary of Pasireotide LAR PK Parameter of Accumulation Ratio Randomized Dose Level
Time frame: Day 28 after injections 1 and 3
Change of Tumor Volume From Baseline
Time frame: Baseline, Months 6 , 12
Change in Mean GH Levels From Baseline
Time frame: Baseline, Months 2.75, 3, 6, 9, 12, 18, 24
Change in Ring Size From Baseline
Time frame: Baseline, Months 3, 6, 9, 12
Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase)
Time frame: 12 Months (Core phase)
Change From Baseline in Prolactin
Time frame: Baseline, Months 3, 6, 9, 12
Total-group Response Rate by Visit (Extension Phase)
Time frame: Months 18, 24
Percentage of Overall Participants With the Reduction of Mean GH Levels to <2.5 ug/L by Visit (Extension Phase)
Time frame: Months 18, 24
Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Extension Phase)
Time frame: Months 18, 24
Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase)
Time frame: Baselnine, Months 2.75, 3, 6, 9, 12, 18, 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pasireotide LAR in people with Acromegaly and Pituitary Gigantism, run by Novartis Pharmaceuticals at 27 sites in Japan.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total-group Response Rate at Month 3 (time frame: Month 3). 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 16 Sep 2019.