Clinical Trials


  • An open label study investigating long safety and tolerability of Nasalfent (fentanyl Citrate Nasal spray) in the treatment of Breakthrough Cancer pain (BTCP) in subjects taking Regular Opioid Therapy.

  • 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.

  • A randomized, open label, two-treatment, two-period, single dose, crossover, bioequivalence study of intravenous infusion of liposomal doxorubicin 50 mg/m2, of sun pharmaceutical industries limited India and doxil 50 mg/m2 marketed by tibotec therapepeutics, A division of ortho biotech, USA in 12 patients with advanced breast cancer/ovarian cancer, under fed conditions.

  • Randomized, phase III-b, Multi-center, Open-label, Parallel study of Enoxaparin (low molecular weigh heparin) given concomitantly with chemotherapy vs chemotherapy alone in patients with inoperable gastric and gastro-oesophageal Cancer.

  • Randomized phage 3 study of pemetrexd in combination with cisplatin in combination with cisplatin verses cisplatin monotherapy in Patients with recurrent or Metastatic Head and Neck Cancer.

  • A Phase IIb RCT of Neoadjuvant chemotherapy comparing Paclitaxel, ifosfamide and Cisplatin with Paclitaxel and 5-FU in patients with Locally advanced head and neck cancer.

  • An open label, balanced, randomized, two period, two treatment, two sequence, and two way crossover study to evaluate safety and pharmacokinetic comparision of Intravenous infusion of Paclitaxel Lipid suspension and Taxol in Patients with Metastatic breast cancer “357”.

  • A multicenter, randomized, open label, two-period, two-treatment, two-way crossover, bioequivalence study comparing Capecitabine tablets 500 mg (Manufactured by Intas Pharmaceuticals Ltd., India) to the reference listed drug XELODA 500 mg tablets (Manufactured by Roche Pharma AG, Germany) in patients of Locally Advanced or Metastatic Breast Cancer or Metastatic colorectal Cancer under fed condition.

  • A multicenter, randomized, open label, two-way crossover, bioequivalence study comparing capecitabine 3 X 500 mg (Intas Pharmaceutical Ltd) to the Reference listed XELODA 3 X 500 mg in patients with patients of metastatic Breast Cancer or Metastatic Colorectal cancer under fed condition “238”.

  • A randomized, controlled phase III trial of Picoplatin and Best Supportive care (BSC) versus DSC alone in patients with small cell Lung Cancer (SCLC), Refractory or Progressive within Six Months of Completing First-Line, Platinim-Containing Chemotherapy-poniard protocol 0601.

  • “A phase II study of determine the safety, Efficacy, and Pharmacokinetics of Multiple Intravenous Dose of ALD518 80 MG, 160mg versus Placebo administered to patients with Non-Small cell lungs Cancer – Related Fatigue and cachexia.

  • A Randomized, Open-Label, Phase 2 Trial of drug with or without drug in patients with previously untreated locally advanced or metastatic Non-Squamous Non-Small-Cell Lung Cancer.

  • A multicenter, randomized, open label, two-period, two-treatment, two-way crossover, bioequivalence study comparing drug 500 mg in locally Advanced Breast cancer or metastatic Breast Cancer or Colorectal Cancer Patients under fed condition.

  • A Randomized, Open-Label, Phase 2 Trial of drug with in patients with previously untreated Locally Advanced or metastatic non-Squamous non-small-cell lung cancer.


  • Open-label randomized, multidose, parallel study to evaluate efficacy and safety of iv nanosomal drug lipid suspension and drug.




Clinical Trials completed later:




  • A multicenter multinational phase 3 randomized study to evaluate the safety and efficacy of treating colorectal cancer patients with recurrent Metastases Using LitxTM System plus.




  • Randomized phase II clinical Trial of immunotherapy with an allogenicB7.1/HLA-A1 Trancefected Tumor Cell vaccine in patients with Stages IIIB/IV non small cell Lungs Cancer that have completed first line chemotherapy.




  • Efficacy and safety of Investigational Test Drug in the treatment of active mild to moderate ulcerative colitis: A double blind randomized comparison with placebo and asacolo mesalamine Delayed-Release Tablets (Reference drug) P&G Pharmaceuticals.




  • Randomized, phase III-b, Multi-center, Open-label, Parallel study of enoxaparin (low molecular weight heparin) given concomitantly with chemotherapy vs chemotherapy alone in patients with inoperable gastric and gastro-oesophageal center.




  • A Randomized, double-blind phase III study of Biosimilar of an approval G-CSF and Neupogen and in an adjuvant to combination chemotherapy with platinum and etoposide in patient with small-Cell lung Cancer(SCLC).




  • A Randomized, Double-Blind Phase III study of Biosimilar of an approval G-CSF and Neupogen as in an adjuvant to combination chemotherapy with cyclophosphamide, Doxorubicin, Vincristine and prednisone with or without rituximab in Patients with Non-Hodgkin Lymphoma (SCLC).




  • Randomized Phase II clinical trial of Immunotherapy with an Allogeneic B7.1/HLA-A1 transfected Tumor cell vaccine in Patients with Stages IIIB/IV Non-Small cell lung cancer that have completed first line Chemotherapy.




  • A Double blinded randomized single dose, 2-way crossover bioequivalence study of Docetaxel for Injectable solution (APotex) and Tacotere (Sanofiaventis) in Patients with Non-Small cell Lung Cancer (NSCLC) or Breast cancer.




  • Protocol No.Lm-LLO-E7-15 A Randomized, active therapy controlled phase 2 study to assess to safety and efficacy of ADXS11-001 with and without cisplatin as 2nd line therapy for the treatment of recurrent cervix cancer.




  • Protocol MAGRIT -ADJ 109493: “A double-blind, randomized, placebocontrolled Phase III study to assess the efficacy of recMAGE-A3 + AS15 antigen specific cancer Immunotherapeutic as adjuvant therapy in patients with resectable MAGE-A3-positive Non-Small Cell Lung cancer”




  • A phase III study of Erbb2 Positive advance or Metastatics Gastric or Esophageal or Gastroesophageal Junction adenocarcinoma Treated with Capeciatabine Plus oxaliplatin with or without Lapatinib.




  • Prevention of Recurrence in Early-Stage, Node-Positive Breast cancer with Low to Intermediate HER2 Expression with XXXX Treatment.




  • Magnetic Resonance imaging in patients with central nervous system lesions.




  • A phase I open label randomized multi center study to determine the maximum tolerated dose and limiting toxicity of GENOPEP 1 in solid tumor cancer Patients.




  • A Multicenter, randomized, open label, two treatment, two period, two sequence, multiple-dose, cross-over, bioequivalence study of Everolimus 10 mg tablet once daily manufactured by Par Pharmaceutical, Inc. 1 Ram Ridge Road, Spring Valley, NY 10977,USA with Afinitor (Everolimus) 10 mg tablet manufactured by: Novartis Pharma Stein AG Stein, Switzerland and Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 in Advanced Renal Cell Carcinoma patients under fasting condition. (Completed in 2013)




  • A multicentre, randomized, open label, single dose, two treatment, two period, two sequence, crossover, bioequivalence study under fed conditions comparing Imatinib Mesylate tablets 400 mg (Manufactured by – Shilpa Medicare Limited, Pollepally (V), Jadcherla Mandal, Mahaboobnagar, 509301 India and Manufactured for Ranbaxy Laboratories Limited, India) to the reference listed drug Gleevec® (Imatinib Mesylate) Tablets 400 mg (Manufactured by - Novartis Pharma Stein AG, Stein, Switzerland and Manufactured for - Novartis Pharmaceuticals Corporation, East Hanover, New Jersey-07936) in patients of Philadelphia chromosome positive Chronic Myeloid Leukaemia (Ph + CML), stabilized on Imatinib Mesylate tablets 400mg. (Completed in 2012)




  • A Randomised, Multi- dose, Multi-centre, Comparative Parallel Study to Evaluate Efficacy, Safety and Pharmacokinetic, Characteristics of Intravenous Infusion of Rituximab (Hetero) and Reference Medicinal Product (Rituximab, Roche) in Indian Patients of Non- Hodgkin’s Lymphoma (HERILY Study). (Completed in 2012)




  • A multicentre, randomized, open label, two-period, two-treatment, two-way crossover, bioequivalence study comparing Temozolomide capsules 250 mg (Manufactured by: Fresenius Kabi Oncology Limited, India) to the reference listed drug Temodal (Temozolomide) capsules 250 mg (Manufactured by : Orion Corporation, Orion Pharma Division, Turku, Finland, Distributed by Schering-Plough Products Pharmaceuticals Ltd., Brazil) in Glioblastoma Multiforme or Anaplastic Astrocytoma patients under fasting conditions. (Completed in 2011)




  • A Prospective, Comparative, Open Label, Randomized, Multicentric, Phase III study to compare the safety and efficacy of Bevacizumab of Intas Pharmaceuticals Limited against Avastin™ in Patients with unresectable or Metastatic Non-Squamous Non-Small Cell Lung Cancer. (Completed in 2013)




  • “A multicenter, open label, balanced, randomized, two-treatment, two- period, two-sequence, cross-over bioequivalence study of Pegylated Liposomal Doxorubicin HCl injection IV 2 mg/ mL of Intas Pharmaceuticals Ltd., India, with that of Doxil® 2 mg/mL (Doxorubicin HCl Liposome injection) in ovarian cancer patients whose disease has progressed or recurred after platinum based chemotherapy under fasting condition” (Completed in 2013)




  • “A Randomised, Multi-centre, Double-blind, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of Two Anti-CD20 Monoclonal Antibodies in Combination with CHOP in Patients with CD20-Positive Diffuse Large B-cell Lymphoma” (Completed in 2012)




  • A prospective, adaptive, randomized, open-label, multicenter clinical trial to assess the efficacy and safety of fixed dose combination of capecitabine & cyclophosphamide in patients of metastatic breast cancer with failure of anthracycline and/or taxane chemotherapy (Completed in 2013)




  • Some more clinical trials are in pipeline/ to be started.