Clinical trial • Phase II • Oncology

(3R)-N-[3-[5-(2-CYCLOPROPYLPYRIMIDIN-5-YL)-1H-PYRROLO[2,3-B]PYRIDINE-3-CARBONYL]-2,4-DIFLUOROPHENYL]-3-FLUOROPYRROLIDINE-1-SULFONAMIDE for Tumors harboring BRAF alterations | Primary central nervous system tumours with BRAF V600E mutation or BRAF fusions

Phase II trial of (3R)-N-[3-[5-(2-CYCLOPROPYLPYRIMIDIN-5-YL)-1H-PYRROLO[2,3-B]PYRIDINE-3-CARBONYL]-2,4-DIFLUOROPHENYL]-3-FLUOROPYRROLIDINE-1-SULFONAMIDE f…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Tumors harboring BRAF alterations | Primary central nervous system tumours with BRAF V600E mutation or BRAF fusions
Trial Stage
Phase II
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
23-07-2024
First CTIS Authorization Date
22-08-2024

Trial design

open-label, none/not specified-controlled Phase II trial in Spain, Italy, France and others.

Open Label
Yes
Comparator
None/Not specified
Biomarker Stratified
True: biomarker BRAF alterations (V600E mutation and BRAF fusions); strata by subprotocol (A: BRAF fusions; B: primary CNS tumors; C: rare BRAF V600E-mutated solid tumours; D: BRAF V600E solid tumours not eligible for other subprotocols)
Target Sample Size
125

Eligibility

Recruits 125 paediatric patients.

Vulnerable Population
Vulnerable populations include pediatric participants (min age ≥10 years for subprotocols A, B, C; 16 years for subprotocol D). The submission includes age-specific assent and consent documents (assent forms for ages 8-11, 10-11, 12-16, 17 years; parent/guardian consent forms). Consent is obtained from adult participants; for minors, parent(s)/legal guardian(s) provide consent and age-appropriate assent is obtained from the minor. Multiple language ICF/assent templates are provided (country-specific).

Inclusion criteria

  • {"criterion_text":"- Subprotocol A: 1. Male and female, ≥10 years of age, and weighing ≥30 kg.\n- Subprotocol C: 4. Have an archival tissue sample available meeting protocol requirements. If an archival tissue sample is not available, a newly obtained (before treatment) tumor biopsy may be submitted instead.\n- Subprotocol C: 5. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory.\n- Subprotocol B: 3.Documented BRAF V600E mutation in tumor and/or blood detected by an analytically validated test at CLIA or CLIA-equivalent laboratory approved by sponsor or sponsor-designated central test.\n- Subprotocol C: 6. Received all available standard therapy, is intolerant to available therapies, or treatment with standard therapy is not appropriate.\n- Subprotocol D: 1. Male and female, 16-65 years of age.\n- Subprotocol D: 2. Histologic diagnosis of a solid tumor harboring a BRAFV600E mutation and not elegible for other subprotocols.\n- Subprotocol D: 3. Measurable disease on CT, MRI or physical exam\n- Subprotocol D: 4. Evidence of BRAF V600E mutation in tumor and/or blood detected by genomic tests\n- Subprotocol B: 4. An archival tissue sample available meeting protocol requirements, or fresh biopsy is required if the archival sample is not available for retrospective confirmation test. Tissue obtained most proximal to initiating this subprotocol is preferred.\n- Subprotocol B: 5. Measurable disease based upon specified response criteria, as determined by the radiographic BICR.\n- Subprotocol A: 5. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory.\n- Subprotocol B: 6. All adverse events related to prior therapies (eg, chemotherapy, radiotherapy, surgery) must have resolved to Grade 1 or baseline except for: a. Alopecia (Grade ≤2) b. Sensory neuropathy (Grade ≤2) c. Other adverse events that have resolved to Grade ≤2 that, according to the clinical judgment of the investigator, do not constitute a safety risk to the participant\n- Subprotocol B: 7. Participants who are receiving corticosteroid treatment must be on a stable or decreasing dose of ≤8 mg/day of dexamethasone or equivalent corticosteroid treatment for 7 days prior to first dose of study treatments.\n- Subprotocol A: 2. Histologic diagnosis of a solid tumor or primary CNS tumor.\n- Subprotocol A: 3. Documentation of BRAF gene fusion in tumor and/or blood detected by an analytically validated test by DNA sequencing or RNA (transcriptome) sequencing at CLIA or CLIA-equivalent laboratory or sponsor-designated central laboratory.\n- Subprotocol A: 4. Have an archival tissue sample available meeting protocol requirements. If an archival tissue sample is not available, a newly obtained (before treatment) tumor biopsy may be submitted instead.\n- Subprotocol D: 5. Consent to provide a tumor biopsy.\n- Subprotocol D: 6. Willingness to comply with the ECG substudy procedures\n- Subprotocol D: 7. All AEs related to prior therapies must have resolved to grade 1 or baseline.\n- Subprotocol A: 6. Received all available standard therapy, is intolerant to available therapies, or the investigator has determined that treatment with standard therapy is not appropriate.\n- Subprotocol A: 7. All adverse events related to prior therapies (chemotherapy; radiotherapy; surgery) must have resolved to Grade 1 or baseline\n- Subprotocol B: 1. Male and female, ≥10 years of age, and weighing ≥30 kg.\n- Subprotocol B: 2. Histological diagnosis of a primary CNS tumor, including but not limited to the following: a. Adults (≥18 years) with Grade 1-4 glioma or glioneuronal tumor (including glioblastoma, anaplastic astrocytoma, high grade astrocytoma with piloid features, pilocytic astrocytoma, gliosarcoma, anaplastic pleomorphic xanthoastrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, not otherwise specified [NOS], ganglioglioma, or recurrent LGG), OR b. Pediatric patients (10-17 years of age) with a Grade 3 or 4 glioma or glioneuronal tumor, including those with a prior, histologically confirmed, diagnosis of a low-grade glioma or glioneuronal tumor and now have radiographic or histopathological findings consistent with WHO [2021] Grade 3 or 4 primary CNS tumor. c. Participants must have unresectable, locally advanced or metastatic disease that: i. Had prior treatment with radiotherapy and/or first-line chemotherapy or concurrent chemoradiation therapy (Note: Participants who have a WHO Grade 3 or 4 glioma for whom chemotherapy and/or radiotherapy is not considered standard of care may remain eligible for the study. Consult the Medical Lead to discuss and determine if participant is eligible for enrollment). OR ii. Is intolerant to available therapies OR iii. Treatment with standard therapy is not appropriate.\n- Subprotocol C: 1. Male and female, ≥10 years of age, and weighing ≥30 kg.\n- Subprotocol C: 2. Histologic diagnosis of a rare BRAF V600E-mutated solid tumor that is unresectable, locally advanced or metastatic.\n- Subprotocol C: 3. Documented BRAF V600E mutation in tumor and/or blood detected by an analytically validated test at CLIA or CLIA-equivalent laboratory approved by sponsor or sponsor-designated central test."}

Exclusion criteria

  • {"criterion_text":"- Subprotocol A:3. Prior treatment with MAPK inhibitors active for Class 2 BRAF alterations for advanced unresectable or metastatic disease (including but not limited to tovorafenib [formerly known as DAY 101, TAK 580, and MLN 2480], KIN-2787, BGB-3245, andCFT1946). Note: Participants with pediatric-type LGGs (molecular classification byWHO2021; diagnosed at ≤25 years of age) who had received prior treatment(s)with RAF/BRAF inhibitors are eligible for enrollment, provided there was no evidence of tumor progression on that therapy or within 4 weeks of discontinuation, based upon radiographic assessment.\n- Subprotocol D: 2. Participant has CNS metastases.\n- Subprotocol B: 2. Known or suspected neurofibromatosis-1 (NF-1) and/or Ras related gene alterations.\n- Subprotocol A: 4. Tyrosine kinase inhibitor(s) and/or targeted therapies are allowed (other than BRAF/MAPK pathway inhibitors per Exclusion Criteria 3 and 4) and will be restricted to no more than the number of lines of therapy that are consistent with standard treatment guidelines. NOTE: There is no restriction on the number of lines of chemotherapy or immunotherapy.\n- Subprotocol D: 3. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n- Subprotocol D: 4. Active infection requiring systemic therapy.\n- Subprotocol D: 5. Current or planned participation in a study of an investigational agent or device.\n- Subprotocol D: 6. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral plixorafenib or cobicistat (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).\n- Subprotocol D: 7. Grade ≥ 2 changes in AST, ALT, gamma-glutamyl transaminase (GGT), or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved.\n- Subprotocol D: 8. Use or anticipate the need for medications with known risk for QT-prolonging potential and Torsades de Pointes.\n- Subprotocol B: 3. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n- Subprotocol C: 3. Participant has CNS metastases.\n- Subprotocol B: 4. Active infection requiring systemic therapy.\n- Subprotocol B: 5. Current or planned participation in a study of an investigational agent or device.\n- Subprotocol B: 6. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral plixorafenib (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).\n- Subprotocol A: 5. Malignancy with co-occurring activating RAS mutation(s) at any time.\n- Subprotocol B: 7. Grade ≥ 2 changes in AST, ALT, gamma-glutamyl transaminase (GGT), or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved.\n- Subprotocol D: 9. History of acute or chronic cardiovascular disease or surgery, hypertension, with systolic blood pressure > 160 mm Hg, history of QTc abnormalities, or clinical significant ECG abnormalities.\n- Subprotocol A: 6. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n- Subprotocol A: 7. Current or planned participation in a study of an investigational agent or device.\n- Subprotocol A: 8. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral plixorafenib (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, and small bowel resection).\n- Subprotocol C: 1. Diagnosis of colorectal adenocarcinoma or pancreatic ductal adenocarcinoma (neuroendocrine or acinar tumors are eligible).\n- Subprotocol C: 5. Known or suspected neurofibromatosis-1 (NF-1) and/or RAS related gene alterations.\n- Subprotocol C: 2. Diagnosis of BRAF V600E mutated melanoma, papillary thyroid cancer or NSCLC.\n- Subprotocol B: 1. Prior treatment with BRAF, ERK, and/or MEK inhibitor(s).\n- Subprotocol C: 4. Prior treatment with BRAF, ERK, and/or MEK inhibitor(s), unless otherwise specified for specific tumor types (i.e. low grade serios or borderline ovarian cancer)\n- Subprotocol C: 6. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n- Subprotocol C: 7. Active infection requiring systemic therapy.\n- Subprotocol C: 8. Current or planned participation in a study of an investigational agent or device.\n- Subprotocol C: 9. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral plixorafenib or cobicistat (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).\n- Subprotocol C: 10. Grade ≥ 2 changes in AST, ALT, gamma-glutamyl transaminase (GGT), or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved.\n- Subprotocol D: 1. Known or suspected neurofibromatosis-1 (NF-1) and/or RAS related gene alterations."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Objective Response Rate (ORR) (Subprotocol A, B and C): ORR will be determined by standard tumor response criteria by blinded independent central review (BICR)","definition_or_measurement_approach":"ORR will be determined by standard tumor response criteria by blinded independent central review (BICR)."}
  • {"endpoint_text":"- 2. Pharmacokinetics (Subprotocol D): Systemic exposure of plixorafenib measured by Cmax and AUC.","definition_or_measurement_approach":"Systemic exposure of plixorafenib measured by Cmax and AUC."}

Recruitment

Digital Remote Recruitment
True: digital methods described include Google Ads, landing pages and online patient materials (documented in recruitment materials, particularly for Spain).
Planned Sample Size
125
Recruitment Window Months
59
Consent Approach
Informed consent is obtained from adult participants. For minors, parent(s)/legal guardian(s) provide consent and age-appropriate assent is obtained (assent forms provided for multiple pediatric age bands including 8-11, 10-11, 12-16, 17). Consent and assent materials are provided in country-specific languages (examples: Italian, German, French, Spanish, Swedish, Norwegian, Dutch) and include specific pregnancy and prescreening documents as well as vendor consent (e.g. Greenphire payment information).

Methods

  • Physician referral letters / HCP brochures (country-specific physician referral letters provided e.g. K2_* Physician Referral Letter documents).
  • Patient brochures and HCP clinical trial brochures (country-specific, e.g. K2_NL Patient Brochure, K2_FR HCP brochure, K2_IT patient materials).
  • Patient navigator scripts and landing pages (digital outreach) — Spain materials include Google Ad, Landing Page, Patient Navigator Script.
  • Online advertising (Google Ad) and dedicated landing page (documented for Spain).
  • Site-led recruitment via participating hospitals/oncology centres and phase I units (country-specific recruitment procedures K1_* documents).

Geography

Total Number Of Sites
26
Total Number Of Participants
134

Spain

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
22-08-2024
Processing Time Days
9
Number Of Sites
6
Number Of Participants
40

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology department
Principal Investigator Name
María Vieito Villar
Principal Investigator Email
mvieito@vhio.net
Contact Person Name
María Vieito Villar
Contact Person Email
mvieito@vhio.net
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Phase I Unit
Principal Investigator Name
Alejandro Falcon Gonzalez
Principal Investigator Email
Alejandro.falcon.sspa@juntadeandalucia.es
Contact Person Name
Alejandro Falcon Gonzalez
Site Name
Hospital Infantil Universitario Nino Jesus
Department Name
Pediatric HematologyOncology Department
Principal Investigator Name
Alvaro Lassaletta Atienza
Principal Investigator Email
alvaro.lassaletta@salud.madrid.org
Contact Person Name
Alvaro Lassaletta Atienza
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology department
Principal Investigator Name
Guillermo De Velasco Oria de Ruerda
Principal Investigator Email
gdvelasco.gdv@gmail.com
Contact Person Name
Guillermo De Velasco Oria de Ruerda
Contact Person Email
gdvelasco.gdv@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Phase I and Precision Medicine Unit
Principal Investigator Name
Valentina Gambardella
Principal Investigator Email
VGambardella@incliva.es
Contact Person Name
Valentina Gambardella
Contact Person Email
VGambardella@incliva.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Medical Oncology department
Principal Investigator Name
Alexandra Cortegoso
Contact Person Name
Alexandra Cortegoso

Italy

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
17-09-2024
Processing Time Days
35
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Dipartimento Ematologia e Terapie Innovative
Principal Investigator Name
Paolo Ascierto
Principal Investigator Email
paolo.ascierto@gmail.com
Contact Person Name
Paolo Ascierto
Contact Person Email
paolo.ascierto@gmail.com
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncourology
Principal Investigator Name
Alberto Farolfi
Principal Investigator Email
alberto.farolfi@irst.emr.it
Contact Person Name
Alberto Farolfi
Contact Person Email
alberto.farolfi@irst.emr.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità di Oncologia Medica
Principal Investigator Name
Andrea Necchi
Principal Investigator Email
Necchi.andrea@hsr.it
Contact Person Name
Andrea Necchi
Contact Person Email
Necchi.andrea@hsr.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncologia ed New Drug Development Division for Innovative Therapies
Principal Investigator Name
Giuseppe Curiliano
Principal Investigator Email
giuseppe.curigliano@ieo.it
Contact Person Name
Giuseppe Curiliano
Contact Person Email
giuseppe.curigliano@ieo.it

France

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
03-09-2024
Processing Time Days
21
Number Of Sites
8
Number Of Participants
40

Sites

Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Service Pneumologie
Principal Investigator Name
Jean-Philippe Metges
Principal Investigator Email
jean-philippe.metges@chu-brest.fr
Contact Person Name
Jean-Philippe Metges
Site Name
Oncopole Claudius Regaud
Department Name
Unité de recherche Clinique
Principal Investigator Name
Delphine Larrieu
Principal Investigator Email
larrieur.delphine@iuct-oncopole.fr
Contact Person Name
Delphine Larrieu
Site Name
Institut Gustave Roussy
Department Name
Service Oncologie Médicale
Principal Investigator Name
Samuel Abbou
Principal Investigator Email
samuel.abbou@gustaveroussy.fr
Contact Person Name
Samuel Abbou
Contact Person Email
samuel.abbou@gustaveroussy.fr
Site Name
Timone University Hospital
Department Name
Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques
Principal Investigator Name
Pascale Tomasini
Principal Investigator Email
pascale.tomasini@ap-hm.fr
Contact Person Name
Pascale Tomasini
Contact Person Email
pascale.tomasini@ap-hm.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Service Oncologie Médicale
Principal Investigator Name
Pierre Kubicek
Principal Investigator Email
pierre.kubicek@ico.unicancer.fr
Contact Person Name
Pierre Kubicek
Site Name
Institut Bergonie
Department Name
Service Oncologie Médicale
Principal Investigator Name
Florent Peyraud
Principal Investigator Email
f.peyraud@bordeaux.unicancer.fr
Contact Person Name
Florent Peyraud
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
Service Neurologie
Principal Investigator Name
Mehdi Touat
Principal Investigator Email
mehdi.touat@aphp.fr
Contact Person Name
Mehdi Touat
Contact Person Email
mehdi.touat@aphp.fr
Site Name
Institut De Cancerologie De L Ouest (additional listed site)
Department Name
Service Oncologie Médicale (duplicate listing across entries)
Principal Investigator Name
Pierre Kubicek
Principal Investigator Email
pierre.kubicek@ico.unicancer.fr
Contact Person Name
Pierre Kubicek

Germany

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
30-08-2024
Processing Time Days
17
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut für Klinisch-Onkologische Forschung (IKF)
Principal Investigator Name
Thorsten Oliver Götze
Principal Investigator Email
goetze.thorsten@khnw.de
Contact Person Name
Thorsten Oliver Götze
Contact Person Email
goetze.thorsten@khnw.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Neurologische Klinik Neuroonkologie
Principal Investigator Name
Antje Wick
Principal Investigator Email
antje.wick@med.uni-heidelberg.de
Contact Person Name
Antje Wick
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie (CVK)
Principal Investigator Name
Dominik Modest
Principal Investigator Email
dominik.modest@charite.de
Contact Person Name
Dominik Modest
Contact Person Email
dominik.modest@charite.de

Sweden

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
23-08-2024
Processing Time Days
10
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Department of Hematology, Oncology and Radiation Physics, SUS – Lund, Lasarettsg. 23 A, 221 85 Lund
Principal Investigator Name
Ana Carneiro
Principal Investigator Email
ana.carneiro@med.lu.se
Contact Person Name
Ana Carneiro
Contact Person Email
ana.carneiro@med.lu.se
Site Name
Karolinska University Hospital
Department Name
Department of Clinical Cancer Studies
Principal Investigator Name
Jeffrey Yachnin
Principal Investigator Email
jeffrey.yachnin@regionstockholm.se
Contact Person Name
Jeffrey Yachnin

Norway

Earliest CTIS Part Ii Submission Date
21-04-2025
Latest Decision Or Authorization Date
14-05-2025
Processing Time Days
23
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Helse Bergen HF
Department Name
The Cancer Clinic
Principal Investigator Name
Kjersti Elvestad Hestetun
Principal Investigator Email
kjse@ihelse.net
Contact Person Name
Kjersti Elvestad Hestetun
Contact Person Email
kjse@ihelse.net
Site Name
Oslo University Hospital HF
Department Name
Oncology department
Principal Investigator Name
Tormod Kyrre Guren
Principal Investigator Email
uxtour@ous-hf.no
Contact Person Name
Tormod Kyrre Guren
Contact Person Email
uxtour@ous-hf.no

Netherlands

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
25
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Internal Oncology
Principal Investigator Name
Marjolein Geurts
Principal Investigator Email
neuro-onco-trials@erasmusmc.nl
Contact Person Name
Marjolein Geurts
Contact Person Email
neuro-onco-trials@erasmusmc.nl

Sponsor

Primary sponsor

Full Name
Fore Biotherapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Development LP
Responsibilities
PK samples
Name
Icon Clinical Research Limited
Responsibilities
PK samples; Tissue sample; Programming; DMC; MM; CTL; CT transparency; Legal rep
Name
Imaging Endpoints II LLC
Responsibilities
Medical image analysis/ review - X-ray, MRI, ultrasound, imaging or cat scan.

Third parties

  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Tempus Labs Inc.","duties_or_roles":"NGS Testing","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"PK samples","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"PK samples; Tissue sample; Programming; DMC; MM; CTL; CT transparency; Legal rep","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Imaging Endpoints II LLC","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, imaging or cat scan.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"NGS Testing","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG sub-study","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Interactive response technologies (IRT)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Ireland","full_name":"Millmount Healthcare Limited (DP Packaging and Labelling/ Batch Certification/EU Importer)","duties_or_roles":"DP Packaging and Labelling/ Batch Certification/EU Importer","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Millmount Healthcare Limited (Batch Certification/EU Importation Site)","duties_or_roles":"Batch Certification/EU Importation Site","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
FORE8394 (PLX8394)
Active Substance
(3R)-N-[3-[5-(2-CYCLOPROPYLPYRIMIDIN-5-YL)-1H-PYRROLO[2,3-B]PYRIDINE-3-CARBONYL]-2,4-DIFLUOROPHENYL]-3-FLUOROPYRROLIDINE-1-SULFONAMIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Investigational (IMP11566/00001)
Investigational Product Name
Tybost 150 mg film-coated tablets (COBICISTAT)
Active Substance
COBICISTAT
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Authorised (marketing authorisation EU/1/13/872/002 listed for Tybost)
Starting Dose
150 mg
Dose Levels
150 mg
Maximum Dose
150 mg
Combination Treatment
Yes

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