| CTRI Number |
CTRI/2021/04/032853 [Registered on: 15/04/2021] Trial Registered Prospectively |
| Last Modified On: |
17/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
This is an open label, multi-center pasireotide roll-over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment |
|
Scientific Title of Study
|
An open label, multi-center pasireotide roll-over protocol for patients who have
completed a previous Novartis-sponsored pasireotide study and are judged by
the investigator to benefit from continued pasireotide treatment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2013-000267-84 |
EudraCT |
| CSOM230B2412 Version 04 dated 06 May 2020 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
|
| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Suneela Thatte |
| Designation |
Vice President and Head |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
Unit No. 902, 9th Floor, B Wing, Supreme Business Park,
Hiranandani Gardens, Powai
Mumbai
MAHARASHTRA
Mumbai
India |
| Phone |
912271097200 |
| Fax |
912266774343 |
| Email |
suneela.thatte@iqvia.com |
|
Details of Contact Person
Public Query
|
| Name |
Suneela Thatte |
| Designation |
Vice President and Head |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
Unit No. 902, 9th Floor, B Wing, Supreme Business Park,
Hiranandani Gardens, Powai
Mumbai
MAHARASHTRA
Mumbai
India |
| Phone |
912271097200 |
| Fax |
912266774343 |
| Email |
suneela.thatte@iqvia.com |
|
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Source of Monetary or Material Support
|
| RECORDATI AG
Lindenstrasse 8,
6340 Baar,
Switzerland |
|
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Primary Sponsor
|
| Name |
RECORDATI AG |
| Address |
Lindenstrasse 8,
6340 Baar,
Switzerland |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| IQVIA RDSIndia Pvt Ltd |
Omega Embassy TechSquare,
Marathahalli-Sarjapur Outer Ring Road,
Kadubeesanahalli,
Bangalore – 560103,
Karnataka |
|
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Countries of Recruitment
|
Argentina
Australia
Belgium
Brazil
Bulgaria
Canada
China
Colombia
France
Germany
Greece
Hungary
India
Israel
Italy
Japan
Malaysia
Mexico
Netherlands
Norway
Peru
Poland
Portugal
Republic of Korea
Romania
Russian Federation
Saudi Arabia
Spain
Switzerland
Taiwan
Thailand
Turkey
United Kingdom
United States of America
Venezuela (Bolivarian Republic of) |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nitin Kapoor |
Christian Medical College |
810, Dept of Endocrinology Diabetes & Metabolism, Christian Medical College
Vellore
TAMIL NADU |
04162283437
nitin.endocrine@gmail.com |
| Dr Pramila Kalra |
M S Ramaiah Medical College and Hospitals |
M S Ramaiah Nagar, MSRIT Post
Bangalore
KARNATAKA |
08040502983
08023601983
kalrapramila@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee |
Approved |
| Ethics committee – Silver, |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E240||Pituitary-dependent Cushings disease, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Paseriotide LAR |
Route: Subcutaneous
Frequency: b.i.d. or t.i.d
depending on the parent study
guidance Dose: 600μg |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients eligible for inclusion in this study have to meet all of the following criteria:
1. Patient is currently participating in a Novartis-sponsored study receiving pasireotide (LAR and/or s.c.) on monotherapy or combination therapy (for Cushing’s Disease or Acromegaly) and has fulfilled all required assessments in the parent study and patients that are benefiting from the study treatment have no other alternatives.
2. Patient is currently benefiting from the treatment with pasireotide, as determined by the
investigator
3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study requirements.
4. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
5. Written informed consent obtained prior to enrolling in roll-over study and receiving study medication.
• If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
|
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| ExclusionCriteria |
| Details |
Patients eligible for this study must not meet any of the following criteria
1. Patient has been permanently discontinued from pasireotide study treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
2. 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.
3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 30 days after the final dose of pasireotide s.c. and 84 days after the final dose of pasireotide LAR. Highly effective contraception is defined as either
Total abstinence (when this is in line with the preferred and usual lifestyle of the patientt. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
Male sterilization (at least 6 months prior to enrolling). For female patients on the study the vasectomized male partner should be the sole partner for that patient.
Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate less than 1 percent), for example hormone vaginal ring or transdermal hormone contraception.
In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (ie age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential.
Sexually active males unless they use a condom during intercourse while taking drug and for 1 months after pasireotide s.c. last dose and 3 months after pasireotide LAR last dose and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
If a study patient or partner becomes pregnant or suspects being pregnant during the study treatment or within 1 month after the final dose of pasireotide s.c. or 84 days after the final dose of pasireotide LAR, the Study Doctor needs to be informed immediately and ongoing study treatment with pasireotide has to be stopped immediately. For patients taking pasireotide LAR, the future dose injections will be cancelled |
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| • To evaluate long term safety data Ie SAEs and AEs with pasireotide (s.c. and/or LAR) in a Novartis-sponsored study and have fulfilled all required assessments in the parent study |
Frequency and severity of
AEs/SAEs |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate clinical benefit as assessed by the investigator |
At scheduled visits i.e. Visit 2,3,4 etc. |
|
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Target Sample Size
|
Total Sample Size="158"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "337"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
17/08/2016 |
| Date of Study Completion (India) |
29/04/2023 |
| Date of First Enrollment (Global) |
01/08/2015 |
| Date of Study Completion (Global) |
25/07/2023 |
|
Estimated Duration of Trial
|
Years="10"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Dear Sir/Mam, This is ongoing study transferred to IQVIA (earlier Novartis CTRI Reg. no.: CTRI/2015/06/005880 [Registered on: 04/06/2015]). May we request you to update the Date of first enrollment Global: 01 Aug 2015 and India:17 Aug 2016. This
is a multi-center, open label, phase IV study to provide continued supply of pasireotide
to patients being treated in a current Novartis-sponsored study and who are
benefiting from treatment with pasireotide. Eligible patients are to be
consented and can then continue treatment with pasireotide in this protocol.
All patients at their scheduled visits will have drug dispensing information
and reported adverse events and serious adverse events collected.
A
patient will reach the end of study when pasireotide treatment is permanently discontinued
and the end of treatment visit has been performed. All patients must be followed
up for safety evaluations for 84 days following the last dose of pasireotide long
acting release (LAR) treatment and for 1 month 30 days following the last dose of
pasireotide subcutaneous (s.c.) treatment. The study is expected to remain open
for approximately 10 years from First Patient First Visit (FPFV) (or until
10June2023 in the UK). Patients will continue to be treated in this study until
they are no longer benefiting from their pasireotide treatment as judged by the
Investigator or until one of the protocol discontinuation criteria is met.
Study to allow access to pasireotide for patients
benefiting from pasireotide treatment in a Novartis-sponsored study
CSOM230G2304 (CTRI/2014/08/004837) and CSOM230G2304 (CTRI/2014/08/004837) |