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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05876754


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT05876754
Ethics application status
Date submitted
17/05/2023
Date registered
25/05/2023

Titles & IDs
Public title
An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
Scientific title
An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
Secondary ID [1] 0 0
2022-501463-40
Secondary ID [2] 0 0
DIM-95031-002
Universal Trial Number (UTN)
Trial acronym
ProvIDHe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cholangiocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ivosidenib Oral Tablet

Experimental: Ivosidenib - Ivosidenib 500 mg, taken orally as two 250 mg tablets once daily for an unlimited amount of continuous 28-day cycles


Treatment: Drugs: Ivosidenib Oral Tablet
Ivosidenib 500 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Adverse Events (AEs) from Day 1 of Cycle 1 through 28 days after last study treatment
Timepoint [1] 0 0
Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 days after last study treatment
Primary outcome [2] 0 0
Number of Serious Adverse Events (SAEs) during the study treatment period (from Day 1 of Cycle 1 through the last study treatment intake or withdrawal of consent, whichever comes first).
Timepoint [2] 0 0
Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment, 6 months after last study treatment, 12 months after last study treatment, 18 months after last study treatment
Primary outcome [3] 0 0
Number of QT prolongation events during electrocardiogram (ECG) assessed as Grade 2 or worse occurring from Day 1 of Cycle 1 through 28 days after last study treatment
Timepoint [3] 0 0
Day 1 of cycle 1, week 2 of cycle 1, week 3 of cycle 1, Day 1 of each consecutive cycle, 28 days after last study treatment
Primary outcome [4] 0 0
Change in Eastern Cooperative Oncology Group (ECOG) performance status (PS) score from baseline to worst value out of the post-baseline assessments.
Timepoint [4] 0 0
Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Primary outcome [5] 0 0
Number of Adverse Events (AEs) leading to discontinuation or death from day 1 through 28 days after the last study treatment
Timepoint [5] 0 0
Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 days after last study treatment
Primary outcome [6] 0 0
Total laboratory abnormalities using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 grading scale or the low/normal/high classifications based on laboratory normal ranges.
Timepoint [6] 0 0
Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Primary outcome [7] 0 0
Change from baseline to the worst on-treatment value of laboratory abnormalities.
Timepoint [7] 0 0
Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Primary outcome [8] 0 0
Number of patients with vital sign values outside limits of the normal range at each time point.
Timepoint [8] 0 0
Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Primary outcome [9] 0 0
Mean change from baseline values to the worst on-treatment value of patients with vital signs outside limits of the normal range
Timepoint [9] 0 0
Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Secondary outcome [1] 0 0
Progression-free survival (PFS) time beginning at enrollement
Timepoint [1] 0 0
through 28 days after last treatment
Secondary outcome [2] 0 0
Overall survival (OS)
Timepoint [2] 0 0
through 28 days after last treatment
Secondary outcome [3] 0 0
Duration of response (DOR)
Timepoint [3] 0 0
through 28 days after last treatment
Secondary outcome [4] 0 0
Time to response (TTR)
Timepoint [4] 0 0
through 28 days after last treatment
Secondary outcome [5] 0 0
Change from baseline of Quality of life scores
Timepoint [5] 0 0
through 28 days after last study treatment
Secondary outcome [6] 0 0
Proportion of days at home or hospital for all patients
Timepoint [6] 0 0
through 28 days after last treatment
Secondary outcome [7] 0 0
Change from baseline of health economic measures, as assessed by the 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5).
Timepoint [7] 0 0
through 28 days after last treatment

Eligibility
Key inclusion criteria
* Diagnosis of nonresectable or metastatic Cholangiocarcinoma (CCA), not eligible for curative-intent resection, transplantation, or ablative therapies
* Have a documented IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease
* Have tried at least 1 prior type of systemic therapy for CCA, and have recovered from any side effects
* Female patients of childbearing potential must have a negative blood pregnancy test prior to starting treatment and must agree to use 2 forms of contraception from the time they enroll to 1 month after their last dose of study drug
* Male patients with a female partner with childbearing potential must also agree to use 2 forms of contraception from the time they enroll to 1 month after their last dose of study drug
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Received a prior IDH1 inhibitor
* Have received a transplant
* Have received systemic cancer treatment or radiotherapy within 2 weeks prior to Day 1 of Cycle 1
* Have received hepatic radiation, chemoembolization, and radiofrequency ablation within 4 weeks prior to Day 1 of Cycle 1
* Have ongoing brain metastases requiring steroids
* Have underwent major surgery within 4 weeks of Day 1 of Cycle 1 prior to C1D1
* Have an active hepatitis B (HBV) or hepatitis C (HCV) infections, known positive human immunodeficiency virus (HIV) antibody results, or acquired immunodeficiency syndrome (AIDS) related illness
* Are pregnant or breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal brisbane & Women's Hospital - Brisbane
Recruitment hospital [2] 0 0
St Vincent's Hospital - Fitzroy
Recruitment hospital [3] 0 0
St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC) - Subiaco
Recruitment hospital [4] 0 0
Kinghorn Cancer Centre - Sydney
Recruitment hospital [5] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- Subiaco
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment postcode(s) [5] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
Armenia
State/province [1] 0 0
Yerevan
Country [2] 0 0
Austria
State/province [2] 0 0
Graz
Country [3] 0 0
Austria
State/province [3] 0 0
Linz
Country [4] 0 0
Austria
State/province [4] 0 0
Salzburg
Country [5] 0 0
Austria
State/province [5] 0 0
Wien
Country [6] 0 0
Belgium
State/province [6] 0 0
Brussel
Country [7] 0 0
Belgium
State/province [7] 0 0
Gent
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Belgium
State/province [9] 0 0
Woluwe-Saint-Lambert
Country [10] 0 0
Canada
State/province [10] 0 0
Calgary
Country [11] 0 0
Canada
State/province [11] 0 0
Halifax
Country [12] 0 0
Canada
State/province [12] 0 0
London
Country [13] 0 0
Canada
State/province [13] 0 0
Toronto
Country [14] 0 0
France
State/province [14] 0 0
Lyon
Country [15] 0 0
France
State/province [15] 0 0
Marseille
Country [16] 0 0
France
State/province [16] 0 0
Montpellier
Country [17] 0 0
France
State/province [17] 0 0
Nantes
Country [18] 0 0
France
State/province [18] 0 0
Paris
Country [19] 0 0
France
State/province [19] 0 0
Pessac
Country [20] 0 0
France
State/province [20] 0 0
Poitiers
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Dresden
Country [23] 0 0
Germany
State/province [23] 0 0
Düsseldorf
Country [24] 0 0
Germany
State/province [24] 0 0
Frankfurt
Country [25] 0 0
Germany
State/province [25] 0 0
Freiburg
Country [26] 0 0
Germany
State/province [26] 0 0
Hannover
Country [27] 0 0
Germany
State/province [27] 0 0
München
Country [28] 0 0
Ireland
State/province [28] 0 0
Cork
Country [29] 0 0
Ireland
State/province [29] 0 0
Dublin
Country [30] 0 0
Italy
State/province [30] 0 0
Bologna
Country [31] 0 0
Italy
State/province [31] 0 0
Florence
Country [32] 0 0
Italy
State/province [32] 0 0
Milano
Country [33] 0 0
Italy
State/province [33] 0 0
Napoli
Country [34] 0 0
Italy
State/province [34] 0 0
Reggio Emilia
Country [35] 0 0
Italy
State/province [35] 0 0
Roma
Country [36] 0 0
Italy
State/province [36] 0 0
Rozzano
Country [37] 0 0
Italy
State/province [37] 0 0
San Giovanni Rotondo
Country [38] 0 0
Italy
State/province [38] 0 0
Turin
Country [39] 0 0
Italy
State/province [39] 0 0
Verona
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Seongnam
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Seoul
Country [42] 0 0
Netherlands
State/province [42] 0 0
Amsterdam
Country [43] 0 0
Netherlands
State/province [43] 0 0
Limburg
Country [44] 0 0
Romania
State/province [44] 0 0
Bucarest
Country [45] 0 0
Romania
State/province [45] 0 0
Cluj-Napoca
Country [46] 0 0
Romania
State/province [46] 0 0
Craiova
Country [47] 0 0
Romania
State/province [47] 0 0
Otopeni
Country [48] 0 0
Romania
State/province [48] 0 0
Ploiesti
Country [49] 0 0
Spain
State/province [49] 0 0
A Coruña
Country [50] 0 0
Spain
State/province [50] 0 0
Barcelona
Country [51] 0 0
Spain
State/province [51] 0 0
Córdoba
Country [52] 0 0
Spain
State/province [52] 0 0
Elche
Country [53] 0 0
Spain
State/province [53] 0 0
Madrid
Country [54] 0 0
Spain
State/province [54] 0 0
Pamplona
Country [55] 0 0
Spain
State/province [55] 0 0
Santander
Country [56] 0 0
Sweden
State/province [56] 0 0
Gothenburg
Country [57] 0 0
Sweden
State/province [57] 0 0
Stockholm
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Birmingham
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Glasgow
Country [60] 0 0
United Kingdom
State/province [60] 0 0
London
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Manchester
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Servier Affaires Médicales
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Institut de Recherches Internationales Servier, Clinical Studies Department
Address 0 0
Country 0 0
Phone 0 0
+33 1 55 72 60 00
Fax 0 0
Email 0 0
scientificinformation@servier.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

* sponsored by Servier
* with a first patient enrolled as of 1 January 2004 onwards
* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
After Marketing Authorization in EEA or US if the study is used for the approval.
Available to whom?
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicaltrials.servier.com/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05876754

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 143
The Queen Elizabeth Hospital
Recruitment hospital [2] 144
St Vincent's Hospital (Melbourne) Ltd
Recruitment postcode(s) [1] 144
5011
Recruitment postcode(s) [2] 145
3065
Funding & Sponsors
Primary sponsor
Primary sponsor name
Primary sponsor address
Primary sponsor country
Ethics approval
Ethics application status
Approved
 
Public notes

Contacts
Principal investigator
Title 393 0
Name 393 0
Address 393 0
Country 393 0
Phone 393 0
Fax 393 0
Email 393 0
Contact person for public queries
Title 394 0
Name 394 0
Servier Pharmaceuticals
Address 394 0
L4, Building 9, 588A Swan Street Burnley, VIC 3121, Australia
Country 394 0
Australia
Phone 394 0
1800 153 590
Fax 394 0
Email 394 0
medinfo.au@servier.com
Contact person for scientific queries
Title 395 0
Name 395 0
Servier Pharmaceuticals
Address 395 0
L4, Building 9, 588A Swan Street Burnley, VIC 3121, Australia
Country 395 0
Australia
Phone 395 0
1800 153 590
Fax 395 0
Email 395 0
medinfo.au@servier.com