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AcromegalyPhase 3NCT02354508

Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues

A Phase 3 study testing Pasireotide LAR in people with Acromegaly, run by Novartis Pharmaceuticals at 50 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase IIIb multicenter, open-label; single arm study to evaluate the efficacy and safety of pasireotide LAR 40 mg and 60 mg in patients with inadequately controlled acromegaly with maximal approved doses of first generation somatostatin analogues. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acromegaly
What is being tested?
Pasireotide LAR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
50 sitesin 15 countries
Study dates
31 Mar 2015to 27 Sep 2018
Phase
Phase 3
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

  • Written informed consent
  • Male and female patients ≥18 years
  • Patients with confirmed diagnosis of inadequately controlled acromegaly (mean GH concentration ≥1 μg/L and sex- and age-adjusted IGF-1 >1.3 x ULN)
  • Patients treated with octreotide LAR (30 mg or 40 mg) or lanreotide ATG (120 mg) monotherapy for at least 3 months prior to screening

Who cannot join

  • Concomitant treatment with other medications reducing GH and or IGF-1, unless discontinued 3 months prior to screening
  • Patients with compression of the optic chiasm requiring surgical intervention
  • Diabetic patients with HbA1c >8% at screening
  • Patients who are hypothyroid and not on adequate replacement therapy
  • Patients with symptomatic cholelithiasis and acute or chronic pancreatitis
  • Patients with clinically significant valvular disease
Show all 28Show fewer
  • Patients with risk factors for torsade de pointes (TdP)
  • Hypokalaemia, hypomagnesaemia, uncontrolled hypothyroidism, family history of long QT syndrome or concomitant medications with known risk of TdP
  • Patients with congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, advanced heart block, history of acute MI less than one year prior to study entry or clinically significant impairment in cardiovascular function.
  • Concomitant disease(s) that could prolong the QT interval such as autonomic neuropathy (caused by diabetes or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
  • Patients with liver disease or ALT/AST > 2.0 X ULN, serum bilirubin >2.0 X ULN - Presence of Hepatitis B surface antigen or Hepatitis C antibody test
  • Patients with serum creatinine >2.0 X ULN
  • Patients with WBC <3 X 109/L; Hb 90% < LLN; PLT <100 X 109/L
  • Patients with active or suspected acute or chronic uncontrolled infection
  • Patients who have undergone major surgery/surgical therapy within 4 weeks prior to screening
  • Patients with active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
  • Patients with abnormal coagulation (PT and/or APTT elevated by 30% above normal limits) or patients receiving anticoagulants that affect PT (prothrombin time) or APTT (activated partial thromboplastin time)
  • History of syncope or family history of idiopathic sudden death
  • History of immunocompromise, including a positive HIV test result (ELISA and Western blot)
  • Known hypersensitivity to somatostatin analogues or any other component of pasireotide LAR
  • Patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving pasireotide
  • Patients who have given a blood donation (of 400 ml or more) within 2 months before receiving pasireotide
  • Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
  • Patients with any current or prior medical condition interfering with the conduct of the study or the evaluation of the study results
  • Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study.
  • Sexually active males unless they use a condom during intercourse while taking drug and for 3 months following last dose of pasireotide
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and 3 months following the last dose of pasireotide.

Trial locations and contacts

50 sites in 15 countries.

50 sites in 15 countries

Italy9 sites

  • Novartis Investigative Site

    Ancona, AN, 60126

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Milan, MI, 20122

  • Novartis Investigative Site

    Milan, MI, 20162

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Padova, PD, 35128

  • Novartis Investigative Site

    Palermo, PA, 90127

  • Novartis Investigative Site

    Pisa, PI, 56124

  • Novartis Investigative Site

    Torino, TO, 10126

Other trials in Italy

France8 sites

  • Novartis Investigative Site

    Angers, 49933

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Bron, 69677

  • Novartis Investigative Site

    Nîmes, 30029

  • Novartis Investigative Site

    Reims, 51092

  • Novartis Investigative Site

    Rouen, 76031

  • Novartis Investigative Site

    Saint-Herblain, 44800

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Turkey (Türkiye)5 sites

  • Novartis Investigative Site

    Ankara, 06560

  • Novartis Investigative Site

    Istanbul, TUR, 34098

  • Novartis Investigative Site

    Izmir, 35340

  • Novartis Investigative Site

    Kocaeli, 41380

  • Novartis Investigative Site

    Pendik / Istanbul, Turkey, 34899

Other trials in Turkey (Türkiye)

Argentina3 sites

  • Novartis Investigative Site

    CABA, Buenos Aires, C1180AAX

  • Novartis Investigative Site

    CABA, Buenos Aires, C1428AQK

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires, B7602CBM

Other trials in Argentina

Belgium3 sites

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Edegem, 2650

  • Novartis Investigative Site

    Leuven, 3000

Other trials in Belgium

China3 sites

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100730

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080

Other trials in China

Mexico3 sites

  • Novartis Investigative Site

    Durango, 34270

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44130

  • Novartis Investigative Site

    Mexico City, Mexico City, 02990

Other trials in Mexico

Portugal3 sites

  • Novartis Investigative Site

    Lisbon, 1349 019

  • Novartis Investigative Site

    Porto, 4099-001

  • Novartis Investigative Site

    Porto, 4200-319

Other trials in Portugal

United Kingdom3 sites

  • Novartis Investigative Site

    London, EC1A 7BE

  • Novartis Investigative Site

    Nottingham, NG7 2UH

  • Novartis Investigative Site

    Plymouth, PL6 8DH

Other trials in United Kingdom

Colombia2 sites

  • Novartis Investigative Site

    Bogotá

  • Novartis Investigative Site

    Floridablanca, Santander Department, 57-7

Other trials in Colombia

Hungary2 sites

  • Novartis Investigative Site

    Budapest, 1085

  • Novartis Investigative Site

    Szeged, HUN, 6720

Other trials in Hungary

Malaysia2 sites

  • Novartis Investigative Site

    Pulau Pinang, 10990

  • Novartis Investigative Site

    Wilayah Persekutuan, 62502

Other trials in Malaysia

Romania2 sites

  • Novartis Investigative Site

    Bucharest, 011863

  • Novartis Investigative Site

    Iași, 700127

Other trials in Romania

Brazil1 site

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 21941-590

Other trials in Brazil

Bulgaria1 site

  • Novartis Investigative Site

    Sofia, 1431

Other trials in Bulgaria

About this study

Official title: A Phase IIIb Multicenter, Open-label, Single Arm Study to Evaluate the Efficacy and Safety of Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues

This is a phase IIIb multicenter, open-label; single arm study to evaluate the efficacy and safety of pasireotide LAR 40 mg and 60 mg in patients with inadequately controlled acromegaly with maximal approved doses of first generation somatostatin analogues. The study will enroll inadequately controlled patients by high doses (maximal approved) of first-generation somatostatin analogues given for at least 3 months. Patients will receive pasireotide LAR 40 mg or 60 mg during the 36 week core study phase. Patients who have completed all visits of core phase and have completed all the assessments at the core phase completion visit can move into the 32-week extension phase. Patients can continue with study treatment until pasireotide LAR is commercially available and reimbursed in their respective country or until the end of the extension phase whichever occurs first.

Read the detailed description

This is a phase IIIb multicenter, open-label; single arm study to evaluate the efficacy and safety of pasireotide LAR 40 mg and 60 mg in patients with inadequately controlled acromegaly with maximal doses of first generation somatostatin analogues. The study will enroll inadequately controlled patients by high doses of first-generation somatostatin analogues given for at least 3 months.

Patients will be categorized into two groups. Group 1 consists of patients treated with octreotide LAR 30 mg from countries where octreotide LAR 40mg is approved for the treatment of acromegaly at the time of screening. These patients will start a 3-months run-in phase to receive 40mg octreotide before being considered eligible to enter the core treatment phase. After 3 months of treatment have been completed, and prior to the fourth injection a mean GH and IGF-1 will be assessed. Patients who are achieving biochemical control will be considered a screen failure and they will not qualify for the core phase of the study. They will continue treatment with octreotide LAR 40 mg outside the frame of this study.

Group 2 consists of patients treated with octreotide LAR 30 mg from countries where octreotide 40mg is NOT yet approved at the time of screening. This group also includes patients already treated with octreotide LAR 40 mg or lanreotide ATG 120 mg. Patients should have been treated with the first generation SSAs for at least 3 months prior to screening. Eligible patients can directly enter the core treatment phase of the study. A run-in phase is not required for this patient population.

In the core treatment phase patients will start treatment with pasireotide LAR 40 mg every 4 weeks. At week 12, the mean GH value and IGF-1value will be assessed. Patients who have not achieved biochemical control by week 12 and do not have any tolerability issues with pasireotide LAR 40 mg will have the dose increased to 60 mg. Patients who have achieved biochemical control by week 12 will maintain a dose of pasireotide LAR 40 mg. A mean GH value and IGF-1 value will be assessed every 12 weeks until Visit 777. At weeks 16 and 28, the investigator will be able to adjust the dose based on the achievement of biochemical control and drug tolerability. If tolerability issues occur, the dose can be decreased in 20 mg. Once the tolerability issue resolves, the patients should return to the dose previously received. Patients will be treated for a total of 36 weeks during the core phase. During this period any concomitant medication for the treatment of acromegaly is prohibited. Patients are required to complete a core phase completion visit 4 weeks after the last dose of pasireotide LAR is administered. Patients who discontinue from the core phase are also required to complete the core phase completion visit 4 weeks after receiving the last pasireotide LAR dose.

Patients who have completed all visits of core phase and have completed all the assessments at the core phase completion visit (Visit 777) can move into the extension phase. The core phase completion visit performed at Visit 777, will also be the first visit (Visit 18) of the extension phase. At Visit 18, the patients will receive the same dose of pasireotide LAR that they received at week 32 (Visit 17). At week 40 (Visit 19), the investigator will decide the treatment regimen and the pasireotide LAR dose based on the achievement of biochemical control at Visit 777. Patients achieving biochemical control at the end of the core phase will continue pasireotide LAR monotherapy at the same dose of the core phase. Patients who are uncontrolled at the end of the core phase will continue pasireotide LAR 60 mg and they will be allowed to receive concomitant treatment with medications used to treat acromegaly based on the investigator's clinical judgment. GH and IGF-1 levels will be assessed every 12 weeks until week 72. At weeks 52 and 64, the investigator will be able to adjust the dose of pasireotide LAR and the regimen of the concomitant medication used to acromegaly based on the patients achievement of biochemical control and drug tolerability. Patients will be treated for a total of 32 weeks in the extension phase and receive the last dose of study treatment at week 68 (Visit 26). Patients are required to complete an extension phase completion visit (Visit 778) 4 weeks after the last dose of pasireotide LAR is administered. Patients who prematurely discontinue from the extension phase are also required to complete the extension phase completion visit (Visit 778) 4 weeks after receiving the last dose of pasireotide LAR.

After discontinuation from the study or completion of study treatment either at the core phase or extension phase of the study, all patients will be followed for safety for 12 weeks (84 days) after the last study drug administration. This visit can be performed by phone, a study visit for follow-up is not mandatory.

Conditions
Acromegaly
Being tested
Pasireotide LAR
Keywords
acromegaly, GH, IGF-1, pasireotide LAR, SOM230, first generation, somatostatin analogues, growth disorder, gigantism, Pituitary adenoma, pituitary gigantism
Medical subject headings
Acromegaly, Growth Disorders, Gigantism, 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

    Pasireotide 40 mg and 60 mg. Pasireotide 20 mg which was allowed for dose decrease in case of adverse event.

Study groups in NCT02354508
Study groupRoleWhat they receive
Pasireotide LARExperimentalPatients who qualify for the core phase of the study will be treated with pasireotide LAR 40 mg initially. Patients not achieving biochemical control can be up-titrated to pasireotide LAR 60 mg.
Receives: Drug: Pasireotide LAR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall

    Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36.

    Measured: Week 36

  2. Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR 60 mg

    Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36, for participants who had been up-titrated with pasireotide LAR 60 mg.

    Measured: Week 36

  3. Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36

    Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36.

    Measured: Wek 36

  4. Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36

    Percentage of patients who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36, by previous treatment, type of therapy and overall.

    Measured: Week 36

  5. Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 Overall by Baseline Diabetic Status

    Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36, overall by baseline diabetic status.

    Measured: Week 36

  6. Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF

    Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36, by previous treatment and overall - last observation carried forward (LOCF)

    Measured: Week 36

Secondary outcomes (18)

  1. Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36

    Core phase - Changes in mean GH from study baseline to week 36.

    Measured: Baseline, week 36

  2. Core Phase: Change in Standardized IGF-1 Values From Baseline to Week 36

    Core phase - Changes in standardized IGF-1 from study baseline to week 36.

    Measured: Baseline, week 36

  3. Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN

    Percentage of participants achieving GH <1 μg/L and IGF-1 <ULN at weeks 12 and 24 overall and by GH level at screening.

    Measured: Week 12, Week 24, Week 36

  4. Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening

    Percentage of participants achieving IGF-1 <ULN at weeks 12, 24 \& 36.

    Measured: Weeks 12, 24 & 36

  5. Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN Overall by Baseline Diabetic Status

    Core phase - Percentage of patients achieving GH <1μg/L at week 12, 24, 36 overall and by GH level at screening.

    Measured: Weeks 12, 24 & 36

  6. Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL)

    Evaluation of effect of pasireotide LAR on Health Related Quality of Life (HRQoL) was assessed using AcroQoL, an acromegaly-specific quality of life instrument. The AcroQol instrument is comprised of 22 questions divided into two scales: one evaluating physical aspects (8 items) and the other that addresses psychological aspects (14 items). The psychological scale can also be further divided into subscale that evaluates physical appearance and the other subscale focused on the impact of the disease on personal relationships of the patient (7 items each). Each of the questions has a 5-item Likert scale. For each dimension the scores range from 0-4 with 0 being the lowest impact and 4 being the most severe.

    Measured: Baseline, Weeks 12, 24 & 36

  7. Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms

    Symptoms of acromegaly were collected at various visits. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).

    Measured: Weeks 12, 24 & 36

  8. Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline

    Symptoms of acromegaly were collected at various visits. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).

    Measured: Weeks 12, 24 & 36

  9. Core Phase: Change From Baseline in EQ-5D-5L Index Scores

    Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages - the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. This scale is numbered from 0 to 100. 100 means the best health you can imagine.

    0 means the worst health you can imagine.

    Measured: Baseline, Weeks 12, 24 & 36

  10. Core Phase: Change From Baseline in EQ-5D-5L VAS Assessment

    Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages - the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. This scale is numbered from 0 to 100. 100 means the best health you can imagine.

    0 means the worst health you can imagine.

    Measured: Baseline, Weeks 12, 24 & 36

  11. Extension Phase: Percentage of Participants With Mean GH < 1 μg/L and IGF-1 < ULN at Weeks 48, 60 & 72 (Up-titrated to Pasireotide LAR 60 mg)

    Percentage of patients achieving IGF-1 <ULN at weeks 48, 60 \& 72 for participants with up-titrated to Pasireotide LAR 60 mg mg

    Measured: Weeks 48, 60 & 72

  12. Extension Phase: Percentage of Participants With Mean GH < 1 μg/L and IGF-1 < ULN at Weeks 48, 60 and 72 (Overall by Baseline Diabetic Status)

    Percentage of participants achieving IGF-1 <ULN at week 46, 60 and 72 overall by baseline diabetic status

    Measured: Weeks 48, 60, 72

  13. Extension Phase: Percentage of Participants With Mean GH < 1 μg/L at Weeks 48, 60, 72 and Overall, Pasireotide Montherapy and Pasireotide With Concomittant Medication and by GH Level at Screening

    Percentage of patients achieving GH <1 μg/L and IGF-1 <ULN at week 48 by treatment with pasireotide LAR alone or with concomitant medications used to treat acromegaly

    Measured: Weeks 48, 60, 72

  14. Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL)

    Evaluation of effect of pasireotide LAR on Health Related Quality of Life (HRQoL) was assessed using AcroQoL, an acromegaly-specific quality of life instrument. The AcroQol instrument is comprised of 22 questions divided into two scales: one evaluating physical aspects (8 items) and the other that addresses psychological aspects (14 items). The psychological scale can also be further divided into subscale that evaluates physical appearance and the other subscale focused on the impact of the disease on personal relationships of the patient (7 items each). Each of the questions has a 5-item Likert scale. For each dimension the scores range from 0-4 with 0 being the lowest impact and 4 being the most severe.

    Measured: Baseline, Weeks 48, 60 & 72

  15. Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms

    Symptoms of acromegaly were collected at various visits. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).

    Measured: Weeks 48, 60 & 72

  16. Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline

    Symptoms of acromegaly were collected at various visits. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).

    Measured: Weeks 48, 60 & 72

  17. Extension Phase: Change From Baseline in EQ-5D-5L Index Scores

    Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages - the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. This scale is numbered from 0 to 100. 100 means the best health you can imagine.

    0 means the worst health you can imagine.

    Measured: Baseline, Weeks 48, 60 & 72

  18. Extension Phase: Change From Baseline in EQ-5D-5L VAS Assessment

    Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages - the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. This scale is numbered from 0 to 100. 100 means the best health you can imagine.

    0 means the worst health you can imagine.

    Measured: Baseline, Weeks 48, 60 & 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2015 (estimated)
  2. Study start31 Mar 2015
  3. Primary completion8 Jan 2018
  4. Study completion27 Sep 2018

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02354508
Sponsor's protocol ID
CSOM230C2413
Other IDs
2014-002630-31, 2014
Status last verified
Dec 2019
First submitted
29 Jan 2015
Last updated
10 Dec 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

Publications

  • Gadelha M, Bex M, Colao A, Pedroza Garcia EM, Poiana C, Jimenez-Sanchez M, Yener S, Mukherjee R, Bartalotta A, Maamari R, Raverot G. Evaluation of the Efficacy and Safety of Switching to Pasireotide in Patients With Acromegaly Inadequately Controlled With First-Generation Somatostatin Analogs. Front Endocrinol (Lausanne). 2020 Feb 3;10:931. doi: 10.3389/fendo.2019.00931. eCollection 2019.

    PubMed 32117045

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pasireotide LAR in people with Acromegaly, run by Novartis Pharmaceuticals at 50 sites in 15 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 4 inclusion and 28 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 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Italy, France, Turkey (Türkiye), Argentina, Belgium and 10 more countries. 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?

Yes. Results are posted in the registry (first posted 4 Dec 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?

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall (time frame: Week 36). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02354508, which also lists 1 linked publication.

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 10 Dec 2019.

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