Phase 2
N=33
Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism
Acromegaly · Pituitary Gigantism
Bottom Line
View on ClinicalTrials.gov: NCT01673646 ↗Enrolled (actual)
33
Serious AEs
33.3%
Results posted
Sep 2019
Primary outcome: Primary: Total-group Response Rate at Month 3 — 18.2 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pasireotide LAR (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total-group Response Rate at Month 3 |
18.2 | — |
| SECONDARY Response Rate at Month 3 by Randomized Dose Level |
9.1; 36.4; 9.1 | — |
| SECONDARY GH Response at Month 3 by Randomized Dose |
27.3; 45.5; 18.2 | — |
| SECONDARY IGF-1 Response at Month 3 by Randomized Dose |
18.2; 45.5; 9.1 | — |
| SECONDARY Total-group Response Rate (GH & IGF-1) Over Time (Core Phase) |
18.2; 21.2; 21.2; 15.2 | — |
| SECONDARY Percentage of Overall Participants With the Reduction of GH Levels to <2.5 ug/L by Visit (Core Phase) |
30.3; 33.3; 30.3; 36.4 | — |
| SECONDARY Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core Phase) |
24.2; 33.3; 39.4; 27.3 | — |
| SECONDARY Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level |
5.36; 8.41; 10.8; 5.86; 10.7; 15.0 | — |
| SECONDARY Summary of Pasireotide LAR PK Parameter of Accumulation Ratio Randomized Dose Level |
1.33; 1.85; 1.64 | — |
| SECONDARY Change of Tumor Volume From Baseline |
-21.0; -1.00 | — |
| SECONDARY Change in Mean GH Levels From Baseline |
-7.60; -5.98; -7.27; -8.83; -8.90; -15.68 | — |
| SECONDARY Change in Ring Size From Baseline |
-1.00; -2.00; -2.00; -2.00 | — |
| SECONDARY Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase) |
9; 6; 10; 1; 4; 0 | — |
| SECONDARY Change From Baseline in Prolactin |
-43.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Total-group Response Rate by Visit (Extension Phase) |
12.5; 30.4 | — |
| SECONDARY Percentage of Overall Participants With the Reduction of Mean GH Levels to <2.5 ug/L by Visit (Extension Phase) |
41.7; 60.9 | — |
| SECONDARY Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Extension Phase) |
16.7; 30.4 | — |
| SECONDARY Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase) |
-8.84; -6.62; -6.71; -5.04; -8.15; -6.35 | — |
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 growth factor-1 (IGF-1) at 3 months of study treatment.
Eligibility Criteria
Inclusion Criteria
- Patients with medication naïve acromegaly or pituitary gigantism
- Patients with inadequately controlled acromegaly or pituitary gigantism
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01673646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.