Clinical Trial Department (Completed / Ongoing Clinical Trial)
CLINICAL TRAIL DEPARMENT
| Name | Qualification | Designation |
| Dr. Naresh Somani | MD,DM (Medical Oncology) | Principal Investigator |
| Dr. Lalit Mohan Sharma | MD (Medical Oncology) | Principal Investigator |
| Dr. Pushplata Gupta | MD (Anesthesia) | Principal Investigator |
| Dr. Pawan Agarwal | MD (Medical Oncology) | Principal Investigator |
| Dr. Tejprakash Soni | MD (Radiation Oncology) | Principal Investigator |
| Dr. Nidhi Patni | MD , DNB (Radiotherapy) | Principal Investigator |
| Dr. Upendra Sharma | MD, DM (Haematology) | Principal Investigator |
| Dr. Ashok Kumar Sinha | MBBS, DHM | Sr. Research Fallow |
| Dr. Harish Singhal | BDS, PGDHHM | Study Coordinator |
| Mr. Pooran Saini | M.Com (B. Adm.), O-Level | Clinical Trial Asst. |
Selected Completed Study At BMCHRC, Jaipur
| 1 | CBKM120H2201- Phase II multicenter randomized, double blind, placebo controlled study assessing the efficacy of buparlisib (BKM120) plus paclitaxel vs. placebo plus paclitaxel in patients with platinum pre-treated recurrent or metastatic head and neck squamous cell carcinoma. | Dr. Naresh Somani |
| 2 | 1200.131 LUX- Head & Neck 2: A randomized, double blind, placebo- controlled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemo-radiotherapy in primary unresected patients with stage III, IVa or IVb loco-regionally advanced head and neck squamous cell carcinoma. | Dr Naresh Somani |
| 3 | IPI – 145- 21: A Phase 2, Randomized Study of Duvelisib Administered in Combination with Rituximab vs R-CHOP in Subjects with Relapsed/Refractory Follicular Lymphoma. | Dr Naresh Somani |
| 4 | Multicentre, Double-Blind, Randomized, Parallel-Group Study to Assess the Efficacy and Safety of Compared With Avastin®, in the First -line treatment of Patient with Stage IV Non-Squamous Non-Small Cell Lung Cancer. (Phase –III) | Dr. Naresh Somani |
| 5 | A randomized, controlled, double-blind Phase III trial to compare the efficacy, safety and pharmacokinetics of GP2013 plus cyclophosphamide, vincristine, prednisone vs. MabThera® plus cyclophosphamide, vincristine,prednisone,followed by GP2013 or MabThera® maintenance therapy in patients with previously untreated, advanced stage follicular lymphoma | Dr. Naresh Somani |
| 6 | An open label, Randomized, Parallel Group , Multi-centre Study to Compare ZOLADEXTM 10.8 mg Given Every 12 Weeks with ZOLADEX 3.6 mg Given Every 4 Weeks in Pre-menopausal Women with Oestrogen Receptor positive Advanced Breast Cancer | Dr. Naresh Somani |
| 7 | Protocol entitled “EPO-ANE-3010/Amendment INT-8 : A Randomized Open-Label, Multicentre, Phase 3 study of Epoetin Alfa plus Standard Supportive Care versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving First-Line Standard Chemotherapy”. No. EPO-ANE-3010 | Dr. Naresh Somani |
| 8 | Protocol No. 2-55-52030-730/TR321: Title” A double-blind, randomized placebo-controlled clinical trial investigating the efficacy and safety of Somatuline Depot (lanreotide) Injection in the treatment of carcinoid syndrome | Dr. Naresh Somani |
| 9 | “A Multi centre, open label, single arm, Phase IV, interventional study to evaluate the efficacty of Erlotinib (Tarceva® ) following 4 cycles of platinum based chemotherapy in patients with locally advanced or metastatic non small cell lung cancer (NSCLC) who have not experienced disease progression or unacceptable toxicity during Chemotherapy” | Dr. Naresh Somani |
| 10 | Protocol I4T-MC-JVBA(c) (also known as IMCL CP12-1027[c]) A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression after One Prior Platinum-Based Therapy | Dr. Naresh Somani |
| 11 | Protocol WSA -CS-008: A Phase III, Double Blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 versus a Caspofungin followed by Voriconazole Regimen in the Treatment of Candidemia and other Invasive Candida Infection” | Dr. Naresh Somani |
| 12 | Protocol No. BI-1200.98, titled “An open label, phase II trial of BIBW 2992 (Afatinib) in patients with Metastatic HER2-overexpressing breast cancer failing HER2-targeted treatment in the neoadjuvant or adjuvant treatment setting” | Dr. Naresh Somani |
| 13 | Multicentre, randomised, double-blind, Phase III trial to investigate the efficacy and safety of oral BIBF 1120 plus standard docetaxel therapy compared to placebo plus standard docetaxel therapy in patients with stage IIIB/IV or recurrent non small cell lung cancer after failure of first line chemotherapy | Dr. Naresh Somani |
| 14 | An Open-Label, Multi-centre, Randomized, Active Controlled, Comparative, Phase III Clinical Study to Assess Efficacy and Safety of Lupin’s Filgrastim Versus Neupogen® as an Adjunct to Chemotherapy for Prevention of Neutropenia in Patients with Non-My7eloid Malignancies. | Dr. Naresh Somani |
| 15 | An International, Multi- Center, Randomized, Double Blind Placebo Controlled Phase II Study to Evaluate the safety and Efficacy of Lucanthone Administered as an Adjunct to Radiation and Temozolomide for Primary Therapy of Glioblastoma Multiforme | Dr. Naresh Somani |
| 16 | A Phase III Randomized Placebo Controlled, Clinical Trial to Study the safety and Efficacy of V212 in Adult Patient with Solid Tumor or Hematologic Malignancy | Dr. Naresh Somani |
| 17 | Protocol P1446-05/19/08: An Open Lable, Multicenter Phase 1 Study Of Selective Cyclin Dependent Kinase Inhibitor P1446A-05 In Subjects With Advanced Refractory Malignacies (Hence Reffered To As ‘SERENiTY’ | Dr. Naresh Somani |
| 18 | Protocol 276-00/31/08: An Open Label, Multicenter Phase/II Study Of Selective Cyclin Dependent Kinase Inhibitor P276-00 In Combination With Radiation In Subjects With Recurrent And/ Or Locally Advanced Squamous Cell Carcinoma Of Head And Neck. | Dr. Naresh Somani |
| 19 | Axitinib (AG-013736) As Second Line Therapy For Metastatic Renal Cell Cancer : Axis Trial Protocol No. : A4061032 | Dr. Naresh Somani |
| 20 | Safety and Efficacy of Recombinant Human Granulocyte-colony Stimulating Factor- rhGCSF (ReliGrast TM or Neupogen®) in Patients with Chemotherapy Induced Neutropenia (Protocol No. : GMX-GCSF-CT001 | Dr. Naresh Somani |
| 21 | A Phase III, Randomized, Double –Blind Study of Galiximab in combination with Rituximab Compared with Rituximab in Combination with placebo for the Treatment of Subjects with Relapsed or Refractory, Follicular Non- Hodgkin’s Lymphoma. Study Number: 114-NH-301. | Dr. Naresh Somani |
| 22 | A Multinational, Randomized, Double Blind Study, Comparing the Efficacy of Aflibercept Once Every 2 weeks versus Placebo in Patients Treated with Gemcitabine for Metastatic Pancreatic Cancer. Protocol No. EFC – 10547 | Dr. Naresh Somani |
| 23 | A Multicentre Randomized, Double Blind, Placebo-Controlled, Parallel Arm Study of the Effect of Intravenous AVE0005 (VEGF Trap) Administered Every 2 Weeks in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites, Protocol No. – EFC6125 (AVE0005A/3001) | Dr. Naresh Somani |
| 24 | A Pivotal Phase 3 Observer-Blind Randomized Clinical Trial of the Efficacy and Safety of APF 530 Compared to Aloxi for the Prevention of Acute-Onset and Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Following Administration of Moderately or Highly Emetogenic Chemotherapy Regimens”. Protocol No:C2006-01 | Dr. Naresh Somani |
| 25 | A Phase 3b, Randomized, Open-Label Study of Bevacizumab (Avastin®) + Temsirolimus (Torisel®) vs. Bevacizumab (Avastin®) + Interferon-Alfa (Roferon®) as First-Line Treatment in Subjects with Advanced Renal Cell Carcinoma (Wyeth Study) | Dr. Naresh Somani |
| 26 | A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib In Metastatic Colorectal Cancer Patients Receiving Irinotecan, 5-Fluorouracil And Leucovorin (Folfiri) As Firstline Treatment. Protocol No. – A6181122 | Dr. Naresh Soamni |
| 27 | Phase III Randomized, Multi Center Study of Sunitinib Malate (SU 011248) or Capecitabine in Subjects with Advanced Breast Cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated. Study A6181107 | Dr. Naresh Somani |
| 28 | An Open-Label Sunitinib Malate (Su011248) Continuation Protocol For Patients Who Have Completed A Prior Sunitinib Study And Are Judged By The Investigator To Have The Potential To Benefit From Sunitinib Treatment. Study A6181114 | Dr. Naresh Somani |
| 29 | A Two-Way Crossover Experimental Evaluation Of Relative Bioavailability Of Two Formulations Of Temozolomide 250 Mg Capsules In Adult Human Male And/Or Female Patients Under Fasting Conditions Protocol No. – 141-06 | Dr. Naresh Somani |
| 30 | International, Randomized,Open-label,phase 3 Trial of Paclitaxel / Carboplatin Plus Pf-3512676 Versus Paclitaxel / Carboplatin Alone As First-Line Treatment Of Patients With Advanced Non-Small Cell Lung Cancer Protocol No. – A8501001 | Dr. Naresh Somani |
| 31 | A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed plus Best Supportive Care versus Best Supportive Care Immediately Following Induction Treatment for Advanced Non-Small Cell Lung Cancer Protocol No. – H3E-MC-JMEN | Dr. Naresh Somani |
| 32 | A Phase 2, Randomized, Double-masked, Placebo-controlled Study to Evaluate the Efficacy of SNX-1012 in Reducing the Duration and Severity of Ulcerative Oral Mucositis in Patients Receiving Cytotoxic Chemotherapy for Breast or Lung Cancer Protocol No. –SNX -1012- CLN2-006 | Dr. Naresh Somani |
| 33 | A Multinational, Randomized, Double Blind Study, Comparing the Efficacy of Aflibercept Once Every 2 weeks versus Placebo in Patients Treated with Gemcitabine for Metastatic Pancreatic Cancer. Protocol No. EFC – 10547 | Dr. Naresh Somani |
| 34 | A Multicentre Randomized, Double Blind, Placebo-Controlled, Parallel Arm Study of the Effect of Intravenous AVE0005 (VEGF Trap) Administered Every 2 Weeks in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites, Protocol No. – EFC6125 (AVE0005A/3001) | Dr. Naresh Somani |
| 35 | A Pivotal Phase 3 Observer-Blind Randomized Clinical Trial of the Efficacy and Safety of APF 530 Compared to Aloxi for the Prevention of Acute-Onset and Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Following Administration of Moderately or Highly Emetogenic Chemotherapy Regimens”. Protocol No:C2006-01 | Dr. Naresh Somani |
| 36 | A Phase 3b, Randomized, Open-Label Study of Bevacizumab (Avastin®) + Temsirolimus (Torisel®) vs. Bevacizumab (Avastin®) + Interferon-Alfa (Roferon®) as First-Line Treatment in Subjects with Advanced Renal Cell Carcinoma (Wyeth Study) | Dr. Naresh Somani |
| 37 | A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib In Metastatic Colorectal Cancer Patients Receiving Irinotecan, 5-Fluorouracil And Leucovorin (Folfiri) As Firstline Treatment. Protocol No. – A6181122 | Dr. Naresh Soamni |
| 38 | LUX-Lung 6: A randomized, open-label, phase III study of BIBW 2992 versus chemotherapy as first-line treatment for patients with Stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR activating mutation. | Dr. Naresh Somani |
| 39 | Protocol No: B7391003“A Phase 3 Randomized, Double-Blind Study of Pf-06439535 Plus Paclitaxel-Carboplatin and Bevacizumab Plus Paclitaxel-Carboplatin for the First-Line Treatment of Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer. | Dr. Lalit Mohan Sharma |
| 40 | Protocol No. L00070 IN 305 B0 : Study Title : A Phase III Study Of Vinflunine Pluse Capecitabine Versus Capecitabine Alone In Apatients With Advance Breast Cancer Previously Treated With Or Resistant To An Anthracycline And Who Are Taxane Resistant | Dr. Lalit Mohan Sharma |
| 41 | AYUSH QOL-2C as an adjuvant therapy for patients of Cancer under chemotherapy/radiotherapy | Dr. Lalit Mohan Sharma |
| 42 | FORTIS-M, LF-0207: A Phase 3, randomized, double-blind, placebo-controlled study of oral talactoferrin in addition to best supportive care in patients with non-small cell lung cancer who have failed two of more prior treatment regimens | Dr. Lalit Mohan Sharma |
| 43 | Protocol number: 1200.42 “Phase III randomized trial of Study drug plus weekly paclitaxel versus Investigator’s choice of chemotherapy following study drug monotherapy in non-small cell lung cancer patients failing previous erlotinib or gefitinib treatment | Dr. Lalit Mohan Sharma |
| 44 | Protocol MORAb-003-004: A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane in Subjects with Platinum-sensitive Ovarian Cancer in First Relapse. | Dr. Lalit Mohan Sharma |
| 45 | Phase II Clinical And Pharmacokinetic Trial of PM00104(Zalypsis ® )in Patients with Advanced and/ or Metastatic Endometrial or Cervical Cancer Previously Treated with One Line of Systemic Chemotherapy. | Dr. Lalit Mohan Sharma |
| 46 | “A Phase IIb RCT of Neoadjuvant chemotherapy comparing Paclitaxel, ifosfamide and Cisplatin with Paclitaxel, cisplatin and 5-FU in Patients with Locally Advanced Head and Neck Cancer.” | Dr. Lalit Mohan Sharma |
| 47 | A Prospective, Open Label Study of ANASTRZOLE In Post-Menopausal Women With Hormone Sensitive Advanced Breast Cancer Protocol No.-D5391L00001 | Dr. Ajay Bapna |
| 48 | A Randomized, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEXTM) 500 mg with Fulvestrant (FASLODEXTM) 250 mg in Postmenopausal Women with Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing | Dr. Ajay Bapna |
| 49 | A randomized, double blind, placebo controlled, Phase 2 study of oral recombinant human lactoferrin (rhLF) monotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed 1st or 2nd line chemotherapy PNo. LF-0201 | Dr. Ajay Bapna |
| 50 | An Open label phase 2 study of oral recombinant human lactoferrin (rhLF) monotherapy in patients with advanced or metastatic renal cell carcinoma (RCC). Protocol No. LF-0202 | Dr. Ajay Bapna |
| 51 | A randomized, double blind, placebo controlled Phase 2 study of oral recombinant human lactoferrin (rhLF) in combination with Carboplatin and Paclitaxel (C/P) chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) Protocol No. LF-0206 | Dr. Ajay Bapna |
| 52 | CPO44/06/FCNS: A Multicentre, Double blind, Double dummy Two phase crossover study of Nasalfent (Fentanyl Citrate Nasal Spray) compared to Immediate Release Morphine Sulphate Tablets in the treatment of Breakthrough Cancer Pain ( BTCP) in subjects taking Regular Opioid Therapy. | Dr. Pushplata Gupta |
| 53 | CP045/06/FCNS: An Open-Label Study Investigating Long-Term Safety and Tolerability of Nasalfent (Fentanyl Citrate Nasal Spray) in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy | Dr. Pushplata Gupta |
| 54 | GWCA01103: A two-part, placebo- controlled, study of the safety and efficacy of Sativex oromucosal spray (Sativex®; Nabiximols) as adjunctive therapy in relieving uncontrolled persistent chronic pain in patients with advanced cancer, who have inadequate analgesia even with optimized chronic opioid therapy. | Dr. Pushplata Gupta |
| 55 | GWCA0999: A multicenter, non-comparative, open-label extension study to assess the long term safety of Sativex oromucosal spray (Sativex®; Nabiximols) as adjunctive therapy in patients with uncontrolled persistent chronic cancer related pain | Dr. Pushplata Gupta |
| 56 | Prospective, multi-centric, open label, two arm, parallel group, active control, randomized, comparative clinical study to evaluate efficacy and safety of R-TPR-029 /Neulasta® (Neulastim®) when given subcutaneously in patients with Chemotherapy Induced Neutropenia (Protocol No.: RLS/TP/2011/01; Version 5.0, Dated: 24 Mar 2014) | Dr. Pawan Agarwal |
| 57 | BM100-CC-03-I-01 A Double Blind, Randomized, Active Controlled, Parallel Design, Comparative PK, Efficacy, Safety and Immunogenicity Study of Bmab-100 and Avastin®, both in Combination with XELOX Chemotherapy in Patients with Metastatic Colorectal Cancer | Dr. Pawan Agarwal |
| 58 | A Phase 1/3, Randomised, Parallel-Group, Active-Controlled, Double-Blind Study to Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan, Each Administered in Combination With Cyclophosphamide, Vincristine, and Prednisone (CVP) in Patients With Advanced Follicular Lymphoma.(Phase –III) (Completed) | Dr .Lalit Mohan Sharma |
| 59 | A Phase 3, Double‑Blind, Randomized, Parallel‑Group, Active‑Controlled Study to Compare the Efficacy and Safety of CT‑P6 and Herceptin as Neoadjuvant and Adjuvant Treatment in Patients with HER2‑Positive Early Breast Cancer (Phase –III) (Completed) | Dr .Lalit Mohan Sharma |
Ongoing Clinical Trial
| 1 | 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) (Recruitment closed) | Dr. Naresh Somani |
| 2 | Ref no . “An open-label, multicenter, Phase IIIb study to assess the safety and efficacy of ribociclib in the combination with letrozole for the treatment of men and pre/postmenopausal women with hormone receptor-positive (HR+) HER2-negative (HER2-) advance breast cancer (aBC) with no prior hormonal therapy for advanced disease” | Dr. Naresh Somani |