Ref: D5086C00001: “A Phase III, Open Label, Randomised, 3-Arm, Multi-Centre Study of Savolitinib plus Durvalumab versus Sunitinib and Durvalumab Monotherapy in Participants with MET-Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (RCC) (SAMETA), Principal Investigator - Dr. Naresh Somani
Ref: E7080-M091-511: “A Prospective, Multicentre, Post-Marketing Phase IV Study to Assess the safety and Efficacy of Lenvatinib as First-Line Treatment in Patients with Unresectable Hepatocellular Carcinoma (HCC)” Site: Somani Hospital, Principal Investigator - Dr. Naresh Somani
Ref: Protocol: 0063-17 A global, multicenter, three arms, open-label randomized study to evaluate the e?cacy and safety of Nanosomal Docetaxel Lipid Suspension compared to Taxotere® (Docetaxel Injection Concentrate) in triple-negative breast cancer patients with locally advanced or metastatic breast cancer after failure to prior chemotherapy.
Protocol Title :‘A Prospective, Randomized, Multicentre, Comparative, open-label, Parallel study to evaluate the E?cacy, Safety and Pharmacokinetics of Test-Trastuzumab Emtansine (ZRC-3255; Cadila Healthcare Ltd) and Reference-Trastuzumab Emtansine (Kadcyla@, a product of Roche) in HER2- Positive Metastatic Breast Cancer Patients
Protocol Title: A randomized, double-blind, placebo-controlled, phase III study evaluating the e?cacy and safety of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab as ?rst line therapy for locally advanced or metastatic non-squamous and squamous non-small cell lung cancer subjects (CANOPY-1).
Protocol Title: “A pilot study (Phase II Trial )of Ge?tinib With Pemetrexed as First-Line Therapy in Patients With Advanced Non-squamous Non–Small-Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations positive patients.” (Investigator Initiative Trial)
Protocol Number: WOC/AMS/CT-44/14 “Asurveillance study on the antibiotic susceptibility pattern of bacterial isolates collected from patients at various Indian tertiary care hospitals”
A pilot study (Phase II Trial) of Cetuximab with Afatinib as First-Line Therapy in patients With Advanced Non-Sequamous Non-Samall-Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Multations positive patients. - PI Dr. Naresh Somani
A pilot study (Phase II Trial ) of Gefitinib/Afatinib with pemetrexed as First-Line therapy in Patients with advanced Non-squamous Non-Small-Cell Lung Cancer with Activating Epidermal Growth Factor Receptor Mutations positive patients. PI Dr. Naresh Somani
A pilot study (Phase II Trial ) of Nivolumab with Pemetrexed as Palliative Chemotherapy in Patients with advanced Non-Small-Cell Lung Cancer with Activating Epidermal Growth Factor Receptor Mutations positive patients. PI Dr. Naresh Somani
Protocol No. CA209-887: Study Title: Clinical Outcomes of CLL and MCL patients treated with Ibrutinib : An observational retrospective medical chart review from India - (Recruitment Ongoing) - Dr. Naresh Somani
Safety Study of Nivolumab for Selected Advanced Malignancies in India - (Trial Ongoing Recruitment closed) - Dr. Naresh Somani
Reference: A Two-Part, Open-Label, Randomized, Phase II/III Study of Dinutuximab and Irinotecan versus Irinotecan for Second Line Treatment of Subjects with Relapsed or Refractory Small Cell Lung Cancer - (Trial Ongoing Recruitment closed)
Ref: CLEE011A2404 (COMPLEEMENT-1)
Ref. No. ``A open-label, multicenter, Phase IIIb study to assess the safety and efficacy of ribociclib (FEE011) in combination with letrozole for the treatment of men and pre/postmenopausal women with hormone receptor-positive (HR+) HER2-negative (HER2-) advanced breast cancer (aBC) with no prior hormonal therapy for advanced disease CLEE011A2404. - Principal Investigator- Dr. Naresh Somani
CLDK378A2301- A phase III multicenter, randomized study of oral LDK378 versus standard chemotherapy in previously untreated adult patients with ALK rearranged (ALK-positive), stage IIIB or IV, non-squamous non-small cell lung cancer (Phase-III)- Principal Investigator- Dr. Naresh Somani
Protocol No. WOC/AMS/CT-44/14: A Surveillance Study on the Antibiotic susceptibility pattern of bacterial isolates collected from patients at various Indian Tertiary Care Hospitals (ASPIRE INDIA)
Project # MYL-1402O-3001: Multicentre, Double-Blind, Randomized, Parallel-Group Study to Assess the Efficacy and Safety of MYL-1402O Compared With Avastin®, in the First -line treatment of Patient with Stage IV Non-Squamous Non-Small Cell Lung Cancer.
Protocol No: CLDK378AIN01 A real-world, open-label, multi-center, prospective, non-interventional (observational) study to evaluate the effectiveness and tolerability of ceritinib in Indian pativvents with ALK positive metastatic non-small cell lung cancer who have progressed or are intolerant to crizotinib.
Protocol Title: CPZP034AIC04 Parachute: Pazopanib Real-world Assessment of Clinical effectiveness and safety in patients who have Undergone treatment in different settings in advanced renal cell carcinoma; a prospective, non-interventional, observation study
A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of AMG 785 Treatment in Postmenopausal Women with Osteoporosis.
A Multicenter, Open-Label, Randomized, Parallel-Group, Comparative Study To Evaluate Efficacy, Safety and Tolerability of Fixed Dose Combination of Azelastine and Mometasone Nasal Spray Compared to Azelastine Nasal Spray and Mometasone Nasal Spray in Patients with Seasonal Allergic Rhinitis.
A Randomized, Double Blind, Comparative, Prospective, Multicentre, Parallel Study to assess Efficacy, Safety and Tolerability of Fixed Dose Combination of Repaglinide / Metformin IR Tablet Compared with Metformin IR Tablet Monotherapy or Repaglinide Tablet Monotherapy in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone.
A Randomized, Open Label, Non- Inferiority, Comparative, Multicentric, Parallel group Study Between Fixed Dose Combination of Salbutamol & Beclometasone Pressurized Inhalation CFC Free 100+50mcg/actuation and HFA Propelled pMDI Salbutamol 100 mcg + Beclometasone 50mcg (Clenil Compositum ?HFA spray) in Patients With Stable Persistent Asthma.
A Randomized, Open Label, Non- Inferiority, Comparative, Multicentric Study Between Budesonide 200 ?g in HFA propelled MDI And Beclomethasone Dipropionate 250 ?g in HFA propelled MDI (Clenil? HFA 250 ?g Spray) in a 12-week Treatment Period of Patients With Stable Persistent Asthma
A multicentre, randomized, open label, two-period, two-treatment, two-way crossover, bioequivalence study comparing Capecitabine Tablets USP 500 mg (Manufactured by: Dr. Reddy's Laboratories., India) to the reference listed drug Xeloda? (Capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., New Jersey 07110) in Metastatic Breast Cancer or Colorectal Cancer patients under fed condition.
H9B-MC-BCDM : A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy.
H9B-MC-BCDO : A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy.
H9B-MC-BCDP : A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA).
Protocol Addendum H9B-MC-BCDM(1) : A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy.
Fighting cervical cancer, FOGSI cervical cancer registry, a reaching the unreached FOGSI initiative 2010. A pap smear & HPV DNA & colposcopy based study.
Study No. - PT-101 : Phase 1 Study of Intravaginal Tamoxifen (PT-101): Randomized, double blind study of safety, pharmacokinetic (PK) and pharmacodynamics (PD) in menopausal patients with moderate to severe Vulvar and vaginal atrophy.
Title : Randomized, Comparative, Phase III Clinical Trial to Compare the Efficacy and Safety of Recombinant human Pegylated Granulocyte Colony Stimulating Factor (Peg G-CSF) Versus Granulocyte Colony Stimulating Factor (G-CSF) in Subjects with Nonmyeloid Malignancies Receiving Myelosuppressive Chemotherapy.
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