Primary outcomeNumber· Month 6
Percentage of Responders With Mean Urinary Free Cortisol (UFC) Within Normal Limits
| Group | Value (percentage of responders) |
|---|---|
| Pasireotide 600 μg BID SC or Ramp up Dose 900 μg BID SC | 22.2 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataExtension Study to Assess the Safety and Efficacy of Pasireotide in Participants With Cushing's Disease
NCTNCT00171951 (opens ClinicalTrials.gov in a new tab)Other idCSOM230B2208E1Other id2004-002407-32Other id2004
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 19 participants (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
5 countries
United States, France, Germany, Italy, United Kingdom
- Start
- 13 Aug 2004
- Primary completion
- 8 Jul 2013
- Completion
- 8 Jul 2013
- First posted
- 15 Sept 2005 (estimated)
- Last update posted
- 2 Jun 2021
- Conditions
- Cushing Disease
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200420062008201020122014
- Ph 2
Extension Study to Assess the Safety and Efficacy of Pasireotide in Participants With Cushing's Disease
NCT0017195113 Aug 2004 to 8 Jul 2013
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Cushing's disease is a rare serious condition that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. This study assessed the long-term safety and efficacy of pasireotide in participants with Cushing's disease.
Interventions
- PasireotideDrug
Arms1
Experimental
Pasireotide 600 μg BID SC or Ramp up Dose 900 μg BID SC
Participants received pasireotide 600 micrograms (μg) twice daily (BID) subcutaneously (SC) to achieve or maintain urinary free cortisol (UFC) normalization. If UFC levels were increased at any time, participants received 900 μg BID SC, until no safety or tolerability concerns were observed as per investigators assessment. If the participant was unable to tolerate the 900 μg BID, dosing of 600 μg three times a day was given.
Primary outcomes2
Outcomes the sponsor listed as primary.
Percentage of Responders With Mean Urinary Free Cortisol (UFC) Within Normal Limits
Time frame · Month 6
Registry description
A participant was considered a responder if the mean UFC from the two 24-hour urine samples collected at Month 6 was within normal limits. The normal range for UFC is 55 to 276 nmol/day.
Change From Baseline in Mean Urinary Free Cortisol (UFC)
Time frame · Core Baseline, Days 14/15 (Core study), Months 6, 12, 24 and 102
Registry description
24-hour urine samples were collected to obtain mean UFC measurements. A negative mean change from baseline indicates improvement.
Secondary outcomes(5)
Number of Participants Who Had At Least One Adverse Event (AE)
Time frame · Up to approximately 106 months
Registry description
An AE was any undesirable sign, symptom or medical condition occurring after starting study drug even if the event is not considered to be related to study drug. AEs were assessed according to incident dose group: Pasireotide 1200 μg sc total daily dose (TDD), Pasireotide 1800 μg SC TDD and Pasireotide SC Any Dose. The incident dose for an AE was the last total daily dose administered on or prior to the AE onset date.
Change From Baseline in Serum Cortisol Levels
Time frame · Core Baseline, Day 15 (Core study), Months 6, 12, 24, and Month 105 (end of the study)
Registry description
Blood samples were withdrawn to obtain the serum cortisol levels. A negative change from baseline indicates improvement.
Plasma Trough Concentrations (Ctrough) of Pasireotide in UFC Responders
Time frame · Day 15 (Core study) and Month 6
Registry description
Participants with Cushing's disease were considered responders if mean UFC levels from the 24-hour urine collections at Day 15 (Core study) and at extension Month 6, were within normal limits. Ctrough levels of pasireotide were measured at Day 15 of Core study and Month 6.
Change From Baseline in Plasma Adrenocorticotropic Hormone (ACTH) Levels
Time frame · Core Baseline, Day 15 (Core study), Months 6, 12, 24 and Month 105 (end of the study)
Registry description
Blood samples were withdrawn to obtain the ACTH levels. A negative change from baseline indicates improvement.
Change From Baseline in Gene-expression and Protein in Blood and Urine for Biomarker Development
Time frame · Baseline to end of the study
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Core Baseline, Days 14/15 (Core study), Months 6, 12, 24 and 102
Change From Baseline in Mean Urinary Free Cortisol (UFC)
| Group | Value (nanomoles per 24 hours (nmol/24h)) | Spread |
|---|---|---|
| Pasireotide 600 μg BID SC or Ramp up Dose 900 μg BID SC | 1219.74 | 752.9 |
Secondary and other outcome results(5)
Secondary outcomeCount of participants· Up to approximately 106 months
Number of Participants Who Had At Least One Adverse Event (AE)
| Group | Value (Participants) |
|---|---|
| Pasireotide 600 μg BID SC | 19 |
| Pasireotide 900 μg BID SC | 8 |
Secondary outcomeMean· Core Baseline, Day 15 (Core study), Months 6, 12, 24, and Month 105 (end of the study)
Change From Baseline in Serum Cortisol Levels
| Group | Value (nanomoles per liters (nmol/L)) | Spread |
|---|---|---|
| Pasireotide 600 μg BID SC or Ramp up Dose 900 μg BID SC | 723.60 | 221.5 |
Secondary outcomeMean· Day 15 (Core study) and Month 6
Plasma Trough Concentrations (Ctrough) of Pasireotide in UFC Responders
| Group | Value (nanograms per milliliter (ng/mL)) | Spread |
|---|---|---|
| Pasireotide 600 μg BID SC or Ramp up Dose 900 μg BID SC | 7.0 | 4.3 |
Secondary outcomeMean· Core Baseline, Day 15 (Core study), Months 6, 12, 24 and Month 105 (end of the study)
Change From Baseline in Plasma Adrenocorticotropic Hormone (ACTH) Levels
| Group | Value (picomoles per litre (pmol/L)) | Spread |
|---|---|---|
| Pasireotide 600 μg BID SC or Ramp up Dose 900 μg BID SC | 13.72 | 11.0 |
Secondary outcome· Baseline to end of the study
Change From Baseline in Gene-expression and Protein in Blood and Urine for Biomarker Development
| Group | Value |
|---|---|
| Pasireotide 600 μg BID SC or Ramp up Dose 900 μg BID SC | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Pasireotide 600 μg BID SCParticipants received pasireotide 600 μg BID SC, to achieve or maintain UFC normalization. | 0 / 19 | 2 / 19 | 19 / 19 |
| Pasireotide 900 μg BID SCParticipants received 900 μg BID SC if UFC levels were increased at any time, until no safety or tolerability concerns were observed as per investigators assessment. If the participant was unable to tolerate the 900 μg BID, dosing of 600 μg three times a day was given. | 0 / 8 | 2 / 8 | 8 / 8 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Clinical trial · 2014
6 results
Extended treatment of Cushing's disease with pasireotide: results from a 2-year, Phase II study.
Boscaro et al. 2014Pituitarycited by 38
PMID 23943009PMC4085509DOI 10.1007/s11102-013-0503-3PUB-23943009
CC BY6 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Participants who have completed the 15 days of Pasireotide treatment in the CSOM230B2208 study and have achieved normalization of 24-hour urinary free cortisol. Participants who did not achieve normalization of 24 -hour urinary free cortisol may be enrolled if in the opinion of the investigator the participant is getting significant clinical benefits from treatment with Pasireotide .
* The participant did not experience any unacceptable adverse events of tolerability issues during the original 15 day treatment.
* Female participants of childbearing potential who have not undergone clinically documented total hysterectomy and/or ovariectomy or tubal ligation must agree to use barrier contraception throughout the course of the extension study, and for one month after the study has ended.
Exclusion Criteria:
* Participant who have developed poorly controlled diabetes mellitus as indicated by ketoacidosis or hemoglobin (Hgb) A1C (HgbA1C) \> 10 since starting \[study CSOM230B2208\].
* Participant with persistent alanine aminotransferase (ALT)/ aspartate transaminase (AST) or alkaline phosphatase levels more than 2.5X upper limit of normal (ULN), serum creatinine \> 2.0 X ULN, serum bilirubin \> 2 X ULN.
* Participant with abnormal coagulation (Prothrombin time (PT) and partial thromboplastin time (PTT) elevated by 30% above normal limits), white blood cells (WBC) \<3.0x1'000'000'000/L; Hgb \<12.0g/dL for females, Hgb \<13.0g/dL for males; PLT \<100x1'000'000'000/L.
Other protocol-defined inclusion / exclusion criteria may apply.
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