Clinical Trials
Vision
BCI is dedicated to advancing cancer care through the delivery of cutting-edge research and offering patients best-in-class care, as well as the opportunity to participate in high quality clinical trials and receive early access to innovative medicines.
We believe that collaboration is central to any successful research program, and we are always looking to engage with external public and private organizations, both regionally and internationally, with similar research interests to further expand our reach and portfolio.
We have several established partnerships with leading local and international institutions that complement our research offering through provision of value-added expertise or services, especially in the field of translational research and data science.
Governance
Our research programs are supported by Burjeel Holding’s Department of Research and Health Innovation which governs research activities conducted across our group of hospitals and treating facilities.
We are committed to conducting research to the highest quality and adheres to international standards of Good Clinical Practice (GCP) and guidelines of the Department of Health (DoH) — Abu Dhabi and the Ministry of Health and Prevention (MOHAP) in the UAE.
This is achieved through a well-established and active Ethics Committee/Institutional Review Board (EC/IRB) that operates in compliance with ICH-GCP guidelines. The EC/IRB provides central review and oversight of all research involving human subjects conducted across all Burjeel Holdings’ research facilities.
Individuals involved in clinical research are GCP-trained and fully licensed to undertake research activities. Clinical trials are supported by trained research coordinators and dedicated nursing and pharmacy teams.
Our research programs benefit from access to specialized departments across Burjeel Holdings’ hospitals and medical centers to facilitate the conduct of research. These include but are not limited to the following: outpatient clinics, emergency and critical care units, inpatient wards, molecular and clinical laboratories (OncoHelix-coLAB), radiology, and advanced imaging.
Clinical Studies
Our research portfolio caters to the unmet needs of cancer patients in the UAE and wider region, which are identified though observational studies and addressed through interventional clinical trials (phase I to phase IV) in both solid and hematologic malignancies. For a list of recent clinical trials refer to the table below.
Trial 1
- Study Title: An open-label, dose-escalation, dose-finding, and proof-of-concept trial of SP-420 in subjects with transfusion-dependent β-thalassemia
- Principal Investigator: Dr. Khaled Musallam
- Design: Phase 2, open-label
- Population: Transfusion-dependent beta-thalassemia, adults
- Status: Active – recruiting
- Local Approval Codes: BH/REC/030/22, DOH/CVDC/2022/1627, DOH/CVDC/2023/48, DOH/CVDC/2023/1635, DOH/CVDC/2023/1984
- Sponsor(s): Pharmacosmos A/S (Denmark)
- Links: clinicaltrials.gov identifier (NCT05693909)
Trial 2
- Study Title: A phase 3, double-blind, randomized, placebo-controlled, multicenter study evaluating the efficacy and safety of mitapivat in subjects with transfusion-dependent alpha- or beta-thalassemia (ENERGIZE-T)
- Principal Investigator: Dr. Khaled Musallam
- Design: Phase 3, randomized, double-blind, placebo-controlled
- Population: Transfusion-dependent thalassemia (TDT), adults
- Status: Active — not recruiting
- Local Approval Codes: BH/REC/008/2022, DOH/CVDC/2022/529, DOH/CVDC/2023/477, DOH/CVDC/2023/587, DOH/ADHRTC/2024/1130, DOH/ADHRTC/2024/2020
- Sponsor(s): Agios Pharmaceuticals (USA)
- Links: clinicaltrials.gov identifier (NCT04770779)
Trial 3
- Study Title: A phase 3, double-blind, randomized, placebo-controlled, multicenter study evaluating the efficacy and safety of mitapivat in subjects with non-transfusion-dependent alpha- or beta-thalassemia (ENERGIZE)
- Principal Investigator: Dr. Khaled Musallam
- Design: Phase 3, randomized, double-blind, placebo-controlled
- Population: Non-Transfusion-dependent thalassemia (NTDT), adults
- Status: Active – not recruiting
- Local Approval Codes: BH/REC/007/2022, DOH/CVDC/2022/528, DOH/CVDC/2023/478, DOH/CVDC/2023/586, DOH/ADHRTC/2024/1131, DOH/ADHRTC/2024/2021
- Sponsor(s): Agios Pharmaceuticals (USA)
- Links: clinicaltrials.gov identifier (NCT04770753)
Publication
BCI has a steady and rapidly evolving record of academic publications in peer-reviewed, top tier international journals. Our group has also authored several books that became prime resources for understanding cancer burden in the UAE and region.
Cancer in the Arab World
Humaid O. Al-Shamsi, Ibrahim H. Abu-Gheida, Faryal Iqbal, Aydah Al-Awadhi
Open Access
A Prospective Observational study to describe the pattern and effectiveness of the utilization of different treatment options for Metastatic Renal Cell Carcinoma
Dr. Hassan Jaafar
International Real-World Study of MET Overexpression in Patients with Non-Small Cell Lung Cancer
Dr. Hassan Jaafar
A Phase 2, Randomized, Open-label Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants with Previously Untreated Locally Advanced/Metastatic Programmed Death Ligand 1-Selected Non-Small-Cell Lung Cancer
Dr. Hassan Jaafar
A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Giredestrant in Combination With Phesgo Versus Phesgo After Induction Therapy With Phesgo + Taxane in Patients With Previously Untreated HER2-Positive, Estrogen Receptor-Positive Locally-Advanced or Metastatic Breast Cancer
Dr. Hassan Jaafar
Real-World Treatment Patterns and Clinical Outcomes Among Patients with Metastatic Castration-resistant Prostate Cancer (mCRPC): An Emerging Market Medical Record Review Study
Dr. Hassan Jaafar
A Phase 3 Study of Pembrolizumab in Combination with Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer
Dr. Hassan Jaafar
An Observational Multi-center Study to Evaluate Real-World Treatment Outcomes of Durvalumab-based Regimens in Hepatobiliary Cancers
Dr. Hassan Jaafar
GOLSEEK-4: A Global Randomized, Open-label, Phase 3 Study to Compare Efficacy and Safety of Golcadomide in Combination with Rituximab versus Investigator's Choice in Participants with Relapsed/Refractory Follicular Lymphoma
Dr. Panagiotis Kaloyannidis
IZABRIGHT-Breast01: A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) versus Treatment of Physician's Choice in Patients with Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple Negative Breast Cancer (TNBC) or ER-low, HER2-negative BC who are Ineligible for Anti-PD1/PD-L1 Treatment
Dr. Hassan Jaafar
Other Resources
Burjeel Holdings also has a dedicated Center for Research on Rare Blood Disorders (CR-RBD), for further info please visit: https://burjeelholdings.com/strategy/cr-rbd/
Contact
If you are interested in conducting, participating or learning more about research at BCI, please get in touch with us at research@burjeelholdings.com
