A phase III, randomized, open-label study evaluating efficacy and safety of Giredestrant compared with Fulvestrant, both combined with a CDK4/6 inhibitor, in patients with estrogen receptor-positive, HER2-negative advanced breast cancer with resistance to prior adjuvant endocrine therapy - PionERA

开始日期2024-05-15

申办/合作机构

F. Hoffmann-La Roche Ltd.

[+1]

CTRI/2024/02/062287 / Not yet recruiting临床3期

A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study To Investigate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of RO7200220 Administered Intravitreally In Patients With Uveitic Macular Edema

开始日期2024-03-15

申办/合作机构

Roche Products (India) Pvt Ltd.

CTRI/2024/01/061668 / Active, not recruiting临床3期

A Phase III, Open-Label, Randomized Study Of Atezolizumab With Lenvatinib Or Sorafenib Versus Lenvatinib Or Sorafenib Alone In Hepatocellular Carcinoma Previously Treated With Atezolizumab And Bevacizumab.

开始日期2024-01-31

申办/合作机构

Roche Products (India) Pvt Ltd.

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2018-07-01·Indian Journal of Medical and Paediatric Oncology

Current Treatment Options for Human Epidermal Growth Factor Receptor 2-Directed Therapy in Metastatic Breast Cancer: An Indian Perspective

作者: Sankar, Srinivasan ; Priyanka, Bhattacharya ; Shyam, Aggarwal ; Sudeep, Gupta ; Vijay, Agarwal ; Advani, SH ; Chacko, R ; Krishna, Prasad ; Sanjoy, Chatterjee ; Jagdish, Nigade ; Poonam, Patil ; Alurkar, SS ; Randeep, Singh ; Sahoo, TP ; Chanchal, Goswami ; Rao, RR ; Binay, Swarup ; Amit, Agarwal ; Ashish, Singh ; Rejiv, Rajendranath ; Chirag, Desai ; Manish, Singhal ; Arun, Warrier ; Anil, Kukreja ; Pavithran, Keechilat ; Shona, Nag ; Smruti, BK

AbstractHuman epidermal growth factor receptor 2 (HER2)-positive is an aggressive subtype of breast cancer and has historically been associated with poor outcomes. The availability of various anti-HER2 therapies, including trastuzumab, lapatinib, pertuzumab, and trastuzumab emtansine (TDM-1), has remarkably improved the clinical outcomes in patients with HER2-positive metastatic breast cancer (mBC). However, there is a need to optimize treatment within this population, given the wide variability in clinical presentation. Additionally, geographical and socio-economic considerations too need to be taken into account. To clarify and collate evidence pertaining to HER2-positive metastatic breast cancer, a panel of medical and clinical oncologists from across India developed representative clinical scenarios commonly encountered in clinical practice in the country. This was followed by two meetings wherein each clinical scenario was discussed in detail and relevant evidence appraised. The result of this process is presented in this manuscript as evidence followed by therapeutic recommendations of this panel for management of HER2-positive mBC in the Indian population.

2018-05-20·Journal of Clinical Oncology

An open label, single arm, prospective phase II study to evaluate the efficacy and safety of bevacizumab with gemcitabine and carboplatin as first-line treatment for metastatic triple negative breast cancer patients.

作者: Gupta, Sudeep ; Swarup, Binay ; Deo, SVS ; Koppikar, Smruti B. ; Kilara, Nalini ; Chacko, Raju Titus ; Kukreja, Anil Arjundas ; Raina, Vinod ; Doval, Dinesh ; Shah, Chirag A. ; Nag, Shona Milon ; Babu, Govind K. ; Desai, Chirag

1098Background: There is a higher burden (29.2%-46%) of TNBC patients in India. This single arm, phase II trial evaluated the efficacy and safety of bevacizumab in combination with gemcitabine and ...

2017-03-01·The Journal of the Association of Physicians of India

Efficacy of C.E.R.A. in Routine Clinical Practice for Correction of Anaemia and Maintenance of the Haemoglobin Levels in CKD Patients not on Dialysis.

Article

作者: Kukreja, A ; Joshi, S ; Mohanty, N K ; Kulkarni, S ; Ganju, A ; Deshpande, R ; Promod, P J ; Shah, H A

INTRODUCTIONC.E.R.A. reported effective correction of anaemia and was well tolerated in International studies on CKD patients not on dialysis.OBJECTIVEThe study aimed to describe the management of renal anaemia in CKD patients not on dialysis with C.E.R.A. in routine clinical practice in India.METHODSThis was a prospective, single-arm, open-label, multi-centre, non-interventional, Phase IV study which followed 108 CKD Stage III-IV patients, not on dialysis with Hb < 10 g/dL for correction of anaemia with C.E.R.A.RESULTSOf the 108 patients with Hb < 10 g/dL at baseline, 83 (90.2%) patients achieved target Hb of 10-12 g/dL and the time taken to achieve correction of anaemia was 9.6 weeks ± 6.13 weeks in the Intent-to-treat population. Haemoglobin concentration increased from 8.59 ± 0.808 g/dL pre-therapy to 10.91 ± 0.634 g/dL post-therapy. The change in mean ± SD Hb value was 2.32 ± 0.174 g/dL. Maintenance of Hb levels within the target range of Hb 10 - 12 g/dL was observed in 78.2% of ITT and 80.8% of the PP population for mean duration of 16.69 weeks. Four patients (3.7%) experienced 5 AEs and 2 patients (1.9%) experienced 3 SAEs in the safety population. As per the treating physician none of the AEs or SAEs was considered related to study drug. There were no deaths reported.CONCLUSIONSThis study demonstrated successful correction of anaemia in Indian patients with C.E.R.A. treatment as well as maintenance of Hb levels within the target range. C.E.R.A. was well tolerated with no new safety concerns specific to the Indian population. The less frequent up to monthly dosing schedule of C.E.R.A. may offer clinicians and patients a simplified regimen of anaemia management as compared to traditional frequently administered (thrice weekly to once weekly) ESAs.

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