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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06247995




Registration number
NCT06247995
Ethics application status
Date submitted
17/01/2024
Date registered
8/02/2024

Titles & IDs
Public title
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.
Scientific title
A Phase I/II, Open-label, Multi-center Trial of [177Lu]Lu-NeoB in Combination With Capecitabine in Adult Patients With Gastrin Releasing Peptide Receptor Positive, Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.
Secondary ID [1] 0 0
2023-506717-21-00
Secondary ID [2] 0 0
CAAA603D12101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - [68Ga]Ga-NeoB
Treatment: Drugs - [177Lu]Lu-NeoB
Treatment: Drugs - Capecitabine

Experimental: Dose A: [177Lu]Lu-NeoB 150mCi q6w + capecitabine - \[177Lu\]Lu-NeoB 150mCi q6w + Capecitabine 1000mg/ m2 BID Day1-14 in a 21-day schedule

Experimental: Dose B: [177Lu]Lu-NeoB 100mCi q3w + capecitabine - \[177Lu\]Lu-NeoB 100mCi q3w+ Capecitabine 1000mg/m2 BID Day1-14 in a 21-day schedule

Experimental: Dose C: [177Lu]Lu-NeoB 200mCi q6w + capecitabine - \[177Lu\]Lu-NeoB 200mCi q6w + Capecitabine 1000mg/m2 BID Day1-14 in a 21-day schedule

Experimental: Dose D: [177Lu]Lu-NeoB 100mCi q6w + capecitabine - \[177Lu\]Lu-NeoB 100mCi q6w + Capecitabine 1000mg/m2 BID Day1-14 in a 21-day schedule


Treatment: Drugs: [68Ga]Ga-NeoB
68Ga\]Ga-NeoB serves as a radioactive imaging compound to be used for PET imaging for localization of GRPR positive lesions.

Treatment: Drugs: [177Lu]Lu-NeoB
\[177Lu\]Lu-NeoB is a radioligand therapy drug.

Treatment: Drugs: Capecitabine
Capecitabine is a chemotherapy drug.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase I: Incidence and severity of dose limiting toxicities (DLTs)
Timepoint [1] 0 0
42 days after the first administration of [177Lu]Lu-NeoB
Primary outcome [2] 0 0
Phase I: Incidence and severity of adverse events and serious adverse events for 177-Lu-NeoB in combination with capecitabine
Timepoint [2] 0 0
From start of study treatment until 56 days after the last dose of study treatment, assessed up to approximately 33 months
Primary outcome [3] 0 0
Phase I: Dose modifications for [177Lu]Lu-NeoB in combination with capecitabine
Timepoint [3] 0 0
From start of study treatment until the last dose of study treatment, assessed up to approximately 31 months
Primary outcome [4] 0 0
Phase II: Objective Response Rate (ORR)
Timepoint [4] 0 0
From date of randomization until date of progression, death or further antineoplastic therapy, whichever comes first, assessed up to approximately 88 months
Primary outcome [5] 0 0
Phase II: Clinical Benefit Rate (CBR)
Timepoint [5] 0 0
From date of randomization until date of progression, death or further antineoplastic therapy, whichever comes first, assessed up to approximately 88 months
Primary outcome [6] 0 0
Phase II: Time to Response (TTR)
Timepoint [6] 0 0
From date of randomization until first documented evidence of CR or PR (the response prior to confirmation), assessed up to approximately 88 months
Primary outcome [7] 0 0
Phase II: Duration of Response (DoR)
Timepoint [7] 0 0
From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to approximately 88 months
Primary outcome [8] 0 0
Phase II: Progression Free Survival (PFS)
Timepoint [8] 0 0
From the date of first dose to the date of confirmed progression or death due to any cause, whichever comes first, assessed up to approximately 88 months
Primary outcome [9] 0 0
Phase II: Overall Survival (OS)
Timepoint [9] 0 0
From the date of first dose until date of death from any cause, assessed up to approximately 88 months
Secondary outcome [1] 0 0
Phase I and II: Time activity curves (TACs) related to [177Lu]Lu-NeoB
Timepoint [1] 0 0
After First, Third and Fifth [177Lu]Lu-NeoB administrations: 1-4hrs, 24hrs, 48hrs and 168hrs after infusion.
Secondary outcome [2] 0 0
Phase I and II: Absorbed radiation doses of [177Lu]Lu-NeoB in organs and target lesions
Timepoint [2] 0 0
After First, Third and Fifth [177Lu]Lu-NeoB administrations: 1-4hrs, 24hrs, 48hrs and 168hrs after infusion.
Secondary outcome [3] 0 0
Phase I and II: Concentration of [177Lu]Lu-NeoB in blood over time
Timepoint [3] 0 0
First [177Lu]Lu-NeoB administration: Day 1 (Pre-dose (before start of infusion)), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i)
Secondary outcome [4] 0 0
Phase I and II: Maximum plasma concentration (Cmax) of [177Lu]Lu-NeoB in blood over time
Timepoint [4] 0 0
First [177Lu]Lu-NeoB administration: Day 1 (Pre-dose (before start of infusion)), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i)
Secondary outcome [5] 0 0
Phase I and II: Time of observed drug concentration occurrence (Tmax) of [177Lu]Lu-NeoB in blood over time
Timepoint [5] 0 0
First [177Lu]Lu-NeoB administration: Day 1 (Pre-dose (before start of infusion)), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i)
Secondary outcome [6] 0 0
Phase I and II: Area under the serum concentration-time cure from time zero to the time of last quantifiable concentration (AUClast) of [177Lu]Lu-NeoB in blood over time
Timepoint [6] 0 0
First [177Lu]Lu-NeoB administration: Day 1 (Pre-dose (before start of infusion)), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i)
Secondary outcome [7] 0 0
Phase I and II: Total systemic clearance for intravenous administration (CL) of [177Lu]Lu-NeoB in blood over time
Timepoint [7] 0 0
First [177Lu]Lu-NeoB administration: Day 1 (Pre-dose (before start of infusion)), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i)
Secondary outcome [8] 0 0
Phase I and II: Volume of distribution during the terminal phase following intravenous elimination (Vz) of [177Lu]Lu-NeoB in blood over time
Timepoint [8] 0 0
First [177Lu]Lu-NeoB administration: Day 1 (Pre-dose (before start of infusion)), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i)
Secondary outcome [9] 0 0
Phase I and II: Terminal elimination half-life (T1/2) of [177Lu]Lu-NeoB in blood over time
Timepoint [9] 0 0
First [177Lu]Lu-NeoB administration: Day 1 (Pre-dose (before start of infusion)), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i)
Secondary outcome [10] 0 0
Phase I and II: Positive Percent Agreement (PPA) and Positive Predictive Agreement (PPrA) of [68Ga]Ga-NeoB PET to conventional imaging as reference by central assessment
Timepoint [10] 0 0
Screening
Secondary outcome [11] 0 0
Phase I: Visual assessment of [68Ga]Ga-NeoB PET/CT or PET/MRI image quality with different radioactivity dose ranges, by central assessment
Timepoint [11] 0 0
Screening
Secondary outcome [12] 0 0
Phase I: Objective Response Rate (ORR)
Timepoint [12] 0 0
From date of randomization until date of progression, death or further antineoplastic therapy, whichever comes first, assessed up to approximately 88 months
Secondary outcome [13] 0 0
Phase I: Clinical Benefit Rate (CBR)
Timepoint [13] 0 0
From date of randomization until date of progression, death or further antineoplastic therapy, whichever comes first, assessed up to approximately 88 months
Secondary outcome [14] 0 0
Phase I: Time to Response (TTR)
Timepoint [14] 0 0
From date of randomization until first documented evidence of CR or PR (the response prior to confirmation), assessed up to approximately 88 months
Secondary outcome [15] 0 0
Phase I: Duration of Response (DoR)
Timepoint [15] 0 0
From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to approximately 88 months
Secondary outcome [16] 0 0
Phase I: Progression Free Survival (PFS)
Timepoint [16] 0 0
From the date of first dose to the date of confirmed progression or death due to any cause, whichever comes first, assessed up to approximately 88 months
Secondary outcome [17] 0 0
Phase I: Overall Survival (OS)
Timepoint [17] 0 0
From the date of first dose until date of death from any cause, assessed up to approximately 88 months
Secondary outcome [18] 0 0
Phase II: Incidence and severity of adverse events and serious adverse events for 177-Lu-NeoB in combination with capecitabine
Timepoint [18] 0 0
From start of study treatment until 56 days after the last dose of study treatment, assessed up to approximately 33 months
Secondary outcome [19] 0 0
Phase II: Dose modifications for [177Lu]Lu-NeoB in combination with capecitabine
Timepoint [19] 0 0
From start of study treatment until the last dose of study treatment, assessed up to approximately 31 months

Eligibility
Key inclusion criteria
1. Signed informed consent must be obtained prior to participation in the study.
2. Participant is female or male adult = 18 years old at the time of informed consent(s).
3. Participant has a histologically and/or cytologically documented diagnosis of ER+ breast cancer (ER expression >10% of tumor cell nuclei stain (regardless of PgR expression) (based on the most recently analyzed tissue sample tested by a local laboratory).
4. Participant has HER2-negative (as per ASCO-CAP guidelines Wolff et al 2018) breast cancer defined as a negative in situ hybridization test (ISH) or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative ISH (e.g., FISH, CISH, or SISH) (based on the most recently analyzed tissue sample tested by a local laboratory) is required.
5. Participant received no more than three prior endocrine therapy/ies (single agent or in combination with targeted therapy) regimen/s in the metastatic setting of which at least one included endocrine therapy in combination with a CDK4/6i. In addition:

* in case of confirmed presence of deleterious or suspected deleterious germline BRCA1 or BRCA2 mutation, the participant may also have received a PARP inhibitor-based therapy.
* In case of HER2-low breast cancer (as per ASCO-CAP guidelines Wolff et al 2018), the participant may also have received Enhertu®.

Note: disease progression while on adjuvant ET (with or without CDK4/6i) or within 12 months of completing adjuvant endocrine therapy (with or without CDK4/6i), will be considered a line of therapy.
6. Participant has metastatic breast cancer with radiologically confirmed progression of disease after the most recent therapy
7. Participant must have measurable disease, i.e., at least one measurable lesion as per RECIST 1.1. (a lesion at a previously irradiated site may only be counted as a target lesion if there is a clear sign of progression since the irradiation) as per local assessment.

Note: If only lytic bone lesions are present, they must have at least one lesion with a soft tissue component that can be evaluated by CT or MRI and meets the definition of measurability as per RECIST 1.1 criteria (participants with only one predominantly lytic bone lesion that has been previously irradiated are eligible if there is documented evidence of disease progression of the bone lesion after irradiation).
8. Participant has at least one target lesion [as per RECIST 1.1 and based on the baseline contrast-enhanced CT (or MRI)] with [68Ga]Ga-NeoB uptake above the liver at PET/CT or PET/MRI, as per local reading. In addition:

* Participant with liver or lung disease involvement must show [68Ga]Ga-NeoB uptake above the liver as follows:
* If there is liver disease involvement (in the absence of lung involvement), in = 50% of all CT measurable liver lesions (RECIST 1.1)
* If there is lung disease involvement (in the absence of liver involvement), in = 50% of all CT measurable lung lesions (RECIST 1.1)
* Participants with both liver and lung disease involvement must show [68Ga]Ga-NeoB uptake above the liver in = 50% of all CT measurable lesions either in liver or lung (RECIST 1.1) and in at least one measurable lesion in the remaining organ (lung or liver)
9. Participants with central nervous system (CNS) involvement are eligible providing they meet ALL the following criteria:

* At least 2 weeks from prior therapy completion (including radiation and/or surgery) to initiation of the study treatment
* Clinically stable CNS tumor at the time of screening
* Participant is not receiving steroids and/or anti-epileptic medications for brain metastases at the time of initiation of the radioligand study treatment
10. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
11. Participant has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by local laboratory):

* Absolute neutrophil count = 1.5 × 109/L
* Platelets = 100 × 109/L
* Hemoglobin = 9.0 g/dL
* International Normalized Ratio (INR) =1.5
* Creatinine Clearance =60 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
* Total bilirubin (TBIL) < 1.5 × ULN (any elevated bilirubin should be asymptomatic at enrollment) except for participants with Gilbert's syndrome who may only be included if the total bilirubin is = 3.0 × ULN or direct bilirubin = 1.5 × ULN
* In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN. If the participant has liver metastases, the participant will be eligible for the study if ALT and AST < 5 X ULN.
* Serum lipase = 1.5 × ULN Note: no platelet transfusion, packed red blood cell transfusion, or G-CSF will be allowed during the screening phase after ICF signature
* Participant must have the following laboratory values within normal limits or corrected to within normal limits with supplements before the first dose of study medication:
* Potassium
* Magnesium
* Total Calcium (corrected for serum albumin)
12. Participant must be able to swallow capecitabine tablets.
13. Participant must be able to communicate with the investigator and comply with the requirements of the study procedures.
14. For Phase I part only Female participant must be in postmenopausal status at the time of starting study treatment.

Postmenopausal status is defined either by:
* Prior surgical bilateral oophorectomy (with or without hysterectomy)
* Age =60 years
* Age <60 years and = 12 months of natural (spontaneous) amenorrhea in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression with serum Follicle-Stimulating Hormone (FSH) and estradiol in the postmenopausal range per local normal range.
* Aged < 60 years: therapy-induced amenorrhea for > 12 months with serial measurements of FSH and estradiol in post-menopausal ranges (NCCN V4 2023).
* Aged < 60 years: on tamoxifen with serial measurements of FSH and estradiol in post-menopausal ranges Note: Ovarian radiation or treatment with a gonadotropin releasing hormone agonist (GnRHas e.g. goserelin acetate) is not permitted for induction of ovarian suppression in the Phase I part.
15. For Phase II part only

* Female participant is post-menopausal as per criteria above at the time of starting study treatment.
* Female participant is pre/peri-menopausal at the time of starting study treatment

Pre-menopausal status is defined as either:

* Patient had last menstrual period within the last 12 months OR
* If on tamoxifen or toremifene within the past 14 days, FSH and estradiol in pre-menopausal ranges on serial measurements OR
* In case of therapy induced amenorrhea, FSH and estradiol in pre-menopausal ranges on serial measurements Note: Peri-menopausal status is defined as neither pre-menopausal nor post-menopausal (see definition above)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participant with symptomatic visceral disease or any disease burden that are at risk of life-threatening complications as per the investigator's judgment.
2. Participant has received prior treatment with chemotherapy in the metastatic setting (allowed in neoadjuvant/ adjuvant setting, unless progression or recurrence occurred during or within 12 months after completion of adjuvant chemotherapy).
3. Participant has received prior treatment with capecitabine
4. History of hypersensitivity or contraindication to any of the study treatments or their excipients or to drugs of similar chemical classes.
5. Participant has inflammatory breast cancer at screening.
6. Participant has had major surgery within 14 days prior to starting study treatment or has not recovered from major side effects.
7. Participant has received any prior treatment with a therapeutic radiopharmaceutical
8. Prior External Beam Radiation Therapy (EBRT) to more than 25% of the bone marrow.
9. Participant has a concurrent malignancy or malignancy within 3 years of start of study treatment, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer, or curatively resected cervical cancer.
10. Participant has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection) based on investigator's discretion.
11. Participant has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical study or compromise compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, interstitial lung disease (ILD)/ pneumonitis etc.).
12. Participant has a history of or ongoing acute pancreatitis within 1 year of screening.
13. History or current diagnosis of impaired cardiac function, clinically significant cardiac disease or ECG abnormalities indicating significant risk of safety for participants in the study such as:

* Documented myocardial infarction (MI), angina pectoris, cardiomyopathy, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry
* Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block)
* Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
* Risk factors for TdP including uncorrected hypocalcemia, hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
* Inability to determine the Fridericia QT correction formula (QTcF) interval
* Resting QTcF =450 msec (male) or =460 msec (female) at screening as per standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed locally
* Left Ventricular Ejection Fraction (LVEF) < 50% as determined by echocardiogram (ECHO) or MUGA.
* Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) = 160 mmHg and/or Diastolic Blood Pressure (DBP) = 100 mm Hg, with or without anti-hypertensive medication.
14. Participant is currently receiving brivudine which cannot be discontinued at least 4-week prior to start of capecitabine therapy.
15. Participant is currently receiving NEP inhibitors (i.e., Entresto®) and images for dosimetry assessments cannot be acquired for this participant as per Section 8.7.3.
16. Participant with known deficiency or family history of deficiency of dihydropyrimidine dehydrogenase.
17. Use of other investigational drugs within 5 half-lives of the investigational drug or within 30 days prior to start of study treatment, whichever is longer; or as required by local regulations.
18. Sexually active male participants unwilling to:

* remain abstinent (refrain from sexual intercourse) or
* use a condom, while taking study treatment and for at least 4 months after the last administration of [177Lu]Lu-NeoB, or 3 months after the last dose of capecitabine (or as per locally prescribing information) whichever is longer, in addition to the highly effective method used by the partner who is a female of child-bearing potential.

Note: A condom is required for all sexually active male participants to prevent them from fathering a child and to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above.
19. Participants with legal incapacity to give informed consent, where required by local regulation (e.g. in EU).
20. For Phase II part only

* Pregnant or breast-feeding women
* Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, are not allowed to participate in this study UNLESS they are using highly effective methods of contraception throughout the study and for up to 7 months after the last administration of [177Lu]Lu-NeoB or 6 months after the last dose of capecitabine (or as per locally prescribing information) whichever is longer. Highly effective contraception methods include:
* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
* Female bilateral tubal ligation, female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or total hysterectomy 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 partner sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant.
* Placement of an intrauterine device (IUD) and concurrent use of barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 1
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
14/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/09/2031
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Darlinghurst
Recruitment hospital [2] 0 0
Novartis Investigative Site - Malvern
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Quebec
Country [2] 0 0
China
State/province [2] 0 0
Guangzhou
Country [3] 0 0
China
State/province [3] 0 0
Tianjin
Country [4] 0 0
France
State/province [4] 0 0
Grenoble
Country [5] 0 0
France
State/province [5] 0 0
Saint Herblain
Country [6] 0 0
France
State/province [6] 0 0
Strasbourg
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Seoul
Country [8] 0 0
Singapore
State/province [8] 0 0
Singapore
Country [9] 0 0
Spain
State/province [9] 0 0
Andalucia
Country [10] 0 0
Spain
State/province [10] 0 0
Catalunya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.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?
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 review 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 availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT06247995