ICMR funds new clinical trial IPIROC by KOLGOTRG to test more effective dosing strategy of high-cost PARP inhibitor

New Delhi: The Every Woman study- Low and low-middle-income country edition, published  in the prestigious journal The Lancet on 11th December 2025, where India participated through Kolkata Gynaecological Oncology Trials and Translational Research Group (KOLGOTRG), highlighted how access to costly chemotherapy agents and poor access to clinical trials are considered as global issues.

At the 8th annual meeting organised by KOLGOTRG, a landmark study, IPIROC (Intermittent PARP inhibitor Regimen in Ovarian Cancer) was launched officially. This trial was developed after years of pioneering research by Dr. Asima Mukhopadhyay, Consultant Gynaecologist and Clinician Scientist, along with her team.  Funded by  ICMR (Indian Council of Medical Research) and facilitated by Suraksha Diagnostics Limited (“Suraksha Clinic and Diagnostics”), this trial will be open across all states in India and some sites abroad. It will address a critical issue on how to provide the right dose of  PARP inhibitor with lower side effects and low cost to the right patients. 

The event was graced by the presence of several world leaders  in the field of women’s cancer, such as Dr Michael Bookman, Chair of GCIG (Gyn Cancer Intergroup, USA), Medical Oncologist; Dr. Amit Oza, Past Chair of GCIC, Canada. Medical Oncologist; Kailash Narayan, Prof Radiation Oncology, Melbourne, Australia; Dr Asima Mukhopadhyay, Director KolGOTRG India; Dr Neerja Bhatla – Padmashree Gyn Oncologist. EX HOD AIIMS Delhi; Prof Val Gebski, Senior Statistician, Sydney Australia; Professors and Faculty from SGPGI, KGMU Lucknow, TMH Mumbai, Aster CMI Bengaluru, AIIMS Delhi, NCI Jhajjar and other AIIMS, Institutions across India along with representatives from BDR Pharma and Cepheid, Members of KoLGOTRG were also present.

KOLGOTRG has been pioneering the development of clinical trials and research in women’s cancer as the only research group from India and South Asia to be a member of the Global Consortium Gynaecological Cancer Intergroup or GCIG.   

PARP Inhibitors are targeted therapy treatments for cancer types involving changes or mutations in the BRCA gene. The role of PARP Inhibitors, a group of pharmacological inhibitors of the enzyme poly ADP ribose polymerase (PARP), is to prevent cancer cells from getting access to a certain protein that the cancer can use for repairing DNA damage, known as PARP. PARP Inhibitors prevent cancer cells from repairing their DNA, so that they get destroyed naturally, especially when tumours are deficient in the pathway known as homologous recombination, which can be tested through assays in ovarian and breast cancer patients, known as the HRD assay. Because of high cost and certain side effects, people often discontinue the medicine. After years of research, Dr. Asima Mukhopadhyay and her team, are working on testing whether PARP Inhibitor Rucaparib dosage of twice a week reduces side-effects, while maintaining efficacy as the daily dosing, for ovarian cancer patients.

Dr Asima Mukhopadhyay, Director of KolGOTRG and ROCK ( Regional Ovarian Cancer Centre KOLGOTRG) shared: ‘I extend my heartfelt thanks to  ICMR for funding this important initiative and request oncologists all across India to inform patients about this study, where free access to a costly anti-cancer drug will be provided through a trial. It is a known fact that there are certain barriers where some physicians or cancer centres do not want to participate in such academic clinical trials, where poor patients can substantially benefit from newer interventions. Many people still don’t know that such an opportunity exists, that by being part of a trial, one can get access to a costly drug.” 

She  added: “I also want to thank Suraksha Clinic and  Diagnostics and Directors Dr. Somnath Chatterjee and Ms. Ritu Mittal, for immensely facilitating the setting up of the study by  providing space for ROCK and provision of laboratory facilities for biobanking and development of next generation biomarker assays like the academic HRD and  PARP assay for patient selection, through an unique R&D collaboration with KOLGOTRG.” 

Dr. Asima Mukhopadhyay also explained: “’Academia-industry collaboration is the future’ – citing other examples of KOLGOTRG collaboration with governmental bodies, like the CSIR HCP 40 program in drug development  for women’s cancer in India and collaboration with Suraksha Clinic and Diagnostics Ltd and Cepheid global for an international award winning cervical cancer screening project in Tea gardens of Darjeeling district with logistical support from Ministry of Health and family Welfare, Govt of West Bengal and local NGO, Manisha Nandi foundation.”  

She further acknowledged the support provided by the BDR pharmaceuticals in co-funding the 1st phase of the trial along with the CRUK-DBT seed corn grant and their continual support in the trial co-ordination and access to PARP inhibitors for the current ICMR funded study.

KOLGOTRG felicitated industry partners and global mentors for their unwavering support, while acknowledging the pivotal role played by Governmental funding bodies like ICMR for their vision in  shaping the research direction in India.