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An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma (ProvIDHe)

Primary Purpose

Cholangiocarcinoma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ivosidenib Oral Tablet
Sponsored by
Servier Affaires Médicales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring CCA, Pretreated locally advanced or metastatic cholangiocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • Royal brisbane & Women's Hospital
  • St Vincent's HospitalRecruiting
  • St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)
  • Kinghorn Cancer Centre
  • The Queen Elizabeth HospitalRecruiting
  • Medizinische Universitaet Graz
  • Ordensklinikum Linz GmbH
  • Universitaetsklinik fuer Innere Medizin III, mit Hämatologie, internistischer Onkologie, Hämostaseologie, Infektiologie, Rheumatologie und Onkologisches Zentrum
  • Medizinische Universitaet Wien Universitaetsklinik fuer Innere Medizin I
  • Universite Libre de Bruxelles ULB -
  • Universitair Ziekenhuis Gent UZ Gent
  • UZ Leuven
  • Cliniques Univ St Luc - Gastro-Enterology
  • Hôpital Privé Jean Mermoz
  • Hopital de la Timone
  • CHU Montpellier
  • Centre Hospitalier Universitaire de Nantes CHU de Nantes
  • Institute Mutualiste Montsouris
  • CHU Bordeaux, Hôpital Haut-Lévêque
  • CHU de Poitiers
  • Charite Universittsmedizin Berlin
  • Universitaetsklinikum Carl-Gustav-Carus
  • Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Düsseldorf
  • Universitaetsklinikum Frankfurt
  • Medizinische Fakultaet der Universitaet Freiburg
  • Medizinische Hochschule Hannover
  • Klinikum der Universitaet Muenchen-Grosshadern
  • Policlinico S. Orsola-Malpighi
  • AOU Careggi
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Ospedale San Raffaele
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale
  • IRCCS Arcispedale Santa Maria Nuova
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Humanitas Research Hospital
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)
  • A.O.U. Città della Salute e della Scienza di Torino
  • AOUI Verona - Ospedale Borgo Roma
  • Amsterdam UMC, location AMCRecruiting
  • Universiteit Maastricht UM - Maastricht University Medical Centre MUMCRecruiting
  • Complejo Hospitalario Universitario A Coruña (CHUAC)
  • Hospital Universitari Vall d'Hebron/Vall Hebron Institute of Oncology (VHIO)
  • Hospital Universitario Reina Sofa
  • Hospital General de Elche
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario 12 de octubre
  • Hospital Universitario Fundacion Jimenez Diaz
  • Hospital Universitario HM Sanchinarro
  • Hospital Universitario de Navarra
  • Hospital Universitario Marqués de Valdecilla
  • Sahlgrenska University HospitalRecruiting
  • Karolinska University Hospital
  • University Hospitals Birmingham (UHB) NHS Foundation Trust - Queen Elizabeth Hospital Birmingham (QEHB)
  • Imperial College LondonRecruiting
  • The Beatson Institute West of Scotland Cancer Research
  • University College London Hospital NHS TrustRecruiting
  • The Christie NHS Foundation TrustRecruiting
  • The Newcastle Upon Tyne Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ivosidenib

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Adverse Events (AEs) from Day 1 of Cycle 1 through 28 days after last study treatment
AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. All reported AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), using the latest version.
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).
SAEs related to study drug will be collected irrespective of the time of onset. AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
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
QT interval, using Fridericia's formula [QTcF], to average QTc interval > 480 to 500msec (Grade 2) or worse, as seen during an ECG. This is classified as an Adverse Event of Special Interest (AESI) for this study.
Change in Eastern Cooperative Oncology Group (ECOG) performance status (PS) score from baseline to worst value out of the post-baseline assessments.
ECOG PS scoring consists of Grade 0 - 5, with 0 being the patient is fully active and 5 being the patient is dead. Descriptive statistics of ECOG PS over time will be summarized by frequency. Shift tables may be provided for ECOG PS from baseline to worst value of post-baseline assessments.
Number of Adverse Events (AEs) leading to discontinuation or death from day 1 through 28 days after the last study treatment
Total number of AEs that result in discontinuation from treatment or death. AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
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.
Listing of all laboratory hematology, coagulation, and chemistry data with values flagged as abnormal to show the corresponding NCI-CTCAE grades and the classifications relative to the laboratory normal ranges.
Change from baseline to the worst on-treatment value of laboratory abnormalities.
Abnormalities will be classified by 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. Shift tables using NCI-CTCAE grades to compare baseline to the worst on-treatment value will be used. For laboratory tests, including hematology, coagulation, and chemistry, where NCI-CTCAE grades are not defined, shift tables using the low/normal/high [low and high] classification to compare baseline to the worst on treatment may be generated. On-treatment is considered from Day 1 of Cycle 1 through 28 days after the last dose.
Number of patients with vital sign values outside limits of the normal range at each time point.
Vital signs include systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature.
Mean change from baseline values to the worst on-treatment value of patients with vital signs outside limits of the normal range
On-treatment is considered from Day 1 of Cycle 1 through 28 days after the last dose. Vital signs include systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature.

Secondary Outcome Measures

Progression-free survival (PFS) time beginning at enrollement
PFS is defined as the time from the date of enrollment to the date at which the disease escalates or progresses. It will be assessed using the Kaplan-Meier (KM) method curves and estimates. This will be based on tumor assessments conducted by the investigator according to local clinical practice.
Overall survival (OS)
OS is defined as the time from date of enrollment to the date of death due to any cause. It will be assessed using the Kaplan-Meier (KM) method curves and estimates.
Duration of response (DOR)
DOR is defined as the time from the date of response to either progression or death. It will be assessed using the Kaplan-Meier (KM) method curves and estimates. This will be based on tumor assessments conducted by the investigator according to local clinical practice.
Time to response (TTR)
TTR is defined as the time from the date of enrollment to the date of response. It will be assessed using the Kaplan-Meier (KM) method curves and estimates. This will be based on tumor assessments conducted by the investigator according to local clinical practice.
Change from baseline of Quality of life scores
Measured by the validated European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Cholangiocarcinoma and Gallbladder Cancer Module (QLQ-BIL21). EORTC QLQ-BIL21, will be evaluated for patients with a baseline assessment and at least 1 post-baseline QLQ-BIL21 assessment that generates a score. Change from baseline for each time point, will be summarized using descriptive statistics.
Proportion of days at home or hospital for all patients
Change from baseline of health economic measures, as assessed by the 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5).
Health economic measures, as assessed by the EQ-5D-5L, will be evaluated for patients with a baseline assessment and at least 1 post-baseline EQ-5D-5L assessment that generate a score. Change from baseline scores for each time point will be quantified with descriptive statistics.

Full Information

First Posted
May 17, 2023
Last Updated
September 1, 2023
Sponsor
Servier Affaires Médicales
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1. Study Identification

Unique Protocol Identification Number
NCT05876754
Brief Title
An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
Acronym
ProvIDHe
Official Title
An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Servier Affaires Médicales

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle.
Detailed Description
Ivosidenib is approved in the United States and in EU for the treatment of advanced or metastatic CCA; this study is being conducted to conslidate the data related to the safety, efficacy, and impact on quality of life for patients. This is an open-label, single-arm study of ivosidenib, which means that all patients meeting eligibility criteria will receive two 250 mg ivosidenib tablets, totaling 500mg of drug, to be taken orally, once daily, for 28 consecutive days, also referred to as one cycle. Additional cycles can continue as long as clinical benefit is confirmed by an investigator, and consent is maintained. There will be a screening visit, study visit on day 1 of each cycle, withdrawal visit within 42 days of stopping treatment, and a follow-up visit every 6 months for up to 18 months after stopping treatment. This results in a minimum of 6 study visits for the completion of one 28-day cycle of ivosidenib. One additional study visit will be added on day one of each additional cycle of treatment. Study visits will include an electrocardiogram (ECG), physical exam, tumor assessment, according to local practive at a given site and blood and urine analyses. If at any point ivosidenib is made available as a medical prescription at the patient's site, patients will be withdrawn from the study treatment and patients will be followed to collect data on overall survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma
Keywords
CCA, Pretreated locally advanced or metastatic cholangiocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
All patients, care providers, investigators, and outcomes assessors will know that each patient is taking the active study drug, ivosidenib.
Allocation
N/A
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ivosidenib
Arm Type
Experimental
Arm Description
Ivosidenib 500 mg, taken orally as two 250 mg tablets once daily for an unlimited amount of continuous 28-day cycles
Intervention Type
Drug
Intervention Name(s)
Ivosidenib Oral Tablet
Intervention Description
Ivosidenib 500 mg
Primary Outcome Measure Information:
Title
Number of Adverse Events (AEs) from Day 1 of Cycle 1 through 28 days after last study treatment
Description
AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. All reported AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), using the latest version.
Time Frame
Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 days after last study treatment
Title
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).
Description
SAEs related to study drug will be collected irrespective of the time of onset. AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Time Frame
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
Title
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
Description
QT interval, using Fridericia's formula [QTcF], to average QTc interval > 480 to 500msec (Grade 2) or worse, as seen during an ECG. This is classified as an Adverse Event of Special Interest (AESI) for this study.
Time Frame
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
Title
Change in Eastern Cooperative Oncology Group (ECOG) performance status (PS) score from baseline to worst value out of the post-baseline assessments.
Description
ECOG PS scoring consists of Grade 0 - 5, with 0 being the patient is fully active and 5 being the patient is dead. Descriptive statistics of ECOG PS over time will be summarized by frequency. Shift tables may be provided for ECOG PS from baseline to worst value of post-baseline assessments.
Time Frame
Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Title
Number of Adverse Events (AEs) leading to discontinuation or death from day 1 through 28 days after the last study treatment
Description
Total number of AEs that result in discontinuation from treatment or death. AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Time Frame
Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 days after last study treatment
Title
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.
Description
Listing of all laboratory hematology, coagulation, and chemistry data with values flagged as abnormal to show the corresponding NCI-CTCAE grades and the classifications relative to the laboratory normal ranges.
Time Frame
Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Title
Change from baseline to the worst on-treatment value of laboratory abnormalities.
Description
Abnormalities will be classified by 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. Shift tables using NCI-CTCAE grades to compare baseline to the worst on-treatment value will be used. For laboratory tests, including hematology, coagulation, and chemistry, where NCI-CTCAE grades are not defined, shift tables using the low/normal/high [low and high] classification to compare baseline to the worst on treatment may be generated. On-treatment is considered from Day 1 of Cycle 1 through 28 days after the last dose.
Time Frame
Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Title
Number of patients with vital sign values outside limits of the normal range at each time point.
Description
Vital signs include systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature.
Time Frame
Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Title
Mean change from baseline values to the worst on-treatment value of patients with vital signs outside limits of the normal range
Description
On-treatment is considered from Day 1 of Cycle 1 through 28 days after the last dose. Vital signs include systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature.
Time Frame
Screening visit, Day 1 of cycle 1, Day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS) time beginning at enrollement
Description
PFS is defined as the time from the date of enrollment to the date at which the disease escalates or progresses. It will be assessed using the Kaplan-Meier (KM) method curves and estimates. This will be based on tumor assessments conducted by the investigator according to local clinical practice.
Time Frame
through 28 days after last treatment
Title
Overall survival (OS)
Description
OS is defined as the time from date of enrollment to the date of death due to any cause. It will be assessed using the Kaplan-Meier (KM) method curves and estimates.
Time Frame
through 28 days after last treatment
Title
Duration of response (DOR)
Description
DOR is defined as the time from the date of response to either progression or death. It will be assessed using the Kaplan-Meier (KM) method curves and estimates. This will be based on tumor assessments conducted by the investigator according to local clinical practice.
Time Frame
through 28 days after last treatment
Title
Time to response (TTR)
Description
TTR is defined as the time from the date of enrollment to the date of response. It will be assessed using the Kaplan-Meier (KM) method curves and estimates. This will be based on tumor assessments conducted by the investigator according to local clinical practice.
Time Frame
through 28 days after last treatment
Title
Change from baseline of Quality of life scores
Description
Measured by the validated European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Cholangiocarcinoma and Gallbladder Cancer Module (QLQ-BIL21). EORTC QLQ-BIL21, will be evaluated for patients with a baseline assessment and at least 1 post-baseline QLQ-BIL21 assessment that generates a score. Change from baseline for each time point, will be summarized using descriptive statistics.
Time Frame
through 28 days after last study treatment
Title
Proportion of days at home or hospital for all patients
Time Frame
through 28 days after last treatment
Title
Change from baseline of health economic measures, as assessed by the 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5).
Description
Health economic measures, as assessed by the EQ-5D-5L, will be evaluated for patients with a baseline assessment and at least 1 post-baseline EQ-5D-5L assessment that generate a score. Change from baseline scores for each time point will be quantified with descriptive statistics.
Time Frame
through 28 days after last treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Institut de Recherches Internationales Servier, Clinical Studies Department
Phone
+33 1 55 72 60 00
Email
scientificinformation@servier.com
Facility Information:
Facility Name
Royal brisbane & Women's Hospital
City
Brisbane
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
St Vincent's Hospital
City
Fitzroy
Country
Australia
Individual Site Status
Recruiting
Facility Name
St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)
City
Subiaco
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Kinghorn Cancer Centre
City
Sydney
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
The Queen Elizabeth Hospital
City
Woodville
Country
Australia
Individual Site Status
Recruiting
Facility Name
Medizinische Universitaet Graz
City
Graz
Country
Austria
Individual Site Status
Completed
Facility Name
Ordensklinikum Linz GmbH
City
Linz
Country
Austria
Individual Site Status
Completed
Facility Name
Universitaetsklinik fuer Innere Medizin III, mit Hämatologie, internistischer Onkologie, Hämostaseologie, Infektiologie, Rheumatologie und Onkologisches Zentrum
City
Salzburg
Country
Austria
Individual Site Status
Completed
Facility Name
Medizinische Universitaet Wien Universitaetsklinik fuer Innere Medizin I
City
Wien
Country
Austria
Individual Site Status
Completed
Facility Name
Universite Libre de Bruxelles ULB -
City
Brussel
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Universitair Ziekenhuis Gent UZ Gent
City
Gent
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Cliniques Univ St Luc - Gastro-Enterology
City
Woluwe-Saint-Lambert
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Privé Jean Mermoz
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hopital de la Timone
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Name
CHU Montpellier
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire de Nantes CHU de Nantes
City
Nantes
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Institute Mutualiste Montsouris
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Name
CHU Bordeaux, Hôpital Haut-Lévêque
City
Pessac
Country
France
Individual Site Status
Not yet recruiting
Facility Name
CHU de Poitiers
City
Poitiers
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Charite Universittsmedizin Berlin
City
Berlin
Country
Germany
Individual Site Status
Completed
Facility Name
Universitaetsklinikum Carl-Gustav-Carus
City
Dresden
Country
Germany
Individual Site Status
Completed
Facility Name
Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Completed
Facility Name
Universitaetsklinikum Frankfurt
City
Frankfurt
Country
Germany
Individual Site Status
Completed
Facility Name
Medizinische Fakultaet der Universitaet Freiburg
City
Freiburg
Country
Germany
Individual Site Status
Completed
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Individual Site Status
Completed
Facility Name
Klinikum der Universitaet Muenchen-Grosshadern
City
München
Country
Germany
Individual Site Status
Completed
Facility Name
Policlinico S. Orsola-Malpighi
City
Bologna
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
AOU Careggi
City
Florence
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Ospedale San Raffaele
City
Milano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale
City
Napoli
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
IRCCS Arcispedale Santa Maria Nuova
City
Reggio Emilia
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Humanitas Research Hospital
City
Rozzano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)
City
San Giovanni Rotondo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
A.O.U. Città della Salute e della Scienza di Torino
City
Turin
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
AOUI Verona - Ospedale Borgo Roma
City
Verona
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Amsterdam UMC, location AMC
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Universiteit Maastricht UM - Maastricht University Medical Centre MUMC
City
Limburg
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC)
City
A Coruña
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitari Vall d'Hebron/Vall Hebron Institute of Oncology (VHIO)
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Reina Sofa
City
Córdoba
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital General de Elche
City
Elche
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario 12 de octubre
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario de Navarra
City
Pamplona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
University Hospitals Birmingham (UHB) NHS Foundation Trust - Queen Elizabeth Hospital Birmingham (QEHB)
City
Birmingham
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Imperial College London
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Beatson Institute West of Scotland Cancer Research
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
University College London Hospital NHS Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Christie NHS Foundation Trust
City
Manchester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Newcastle Upon Tyne Hospitals
City
Newcastle Upon Tyne
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
After Marketing Authorization in EEA or US if the study is used for the approval.
IPD Sharing Access Criteria
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.
IPD Sharing URL
http://clinicaltrials.servier.com/

Learn more about this trial

An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

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