Completed trials

1

A single arm, multicentric, open label, efficacy and safety study of Docetaxel Lipid Suspension for Injection of Intas Pharmaceuticals Limited, India in patients with Metastatic Castration Resistant prostate cancer.

2

A Randomized, Parallel group, Phase III study to compare Safety and Efficacy of BFLUID with a commercially available solution, NUTRIFLEX PERI, as a control product in patients undergoing Gastrectomy or Colectomy- (OT-SS-IN-01)

3

A single arm, multicentric, open label, efficacy and safety study of Doceaqualip (Docetaxel Lipid Suspension for Injection of Intas Pharmaceuticals Limited, India) based regimens in metastatic gastric adenocarcinoma patients (0328-17).

4

Safety and Efficacy study of Azadine® (Azacitidine) in treatment of Myelodysplastic Syndrome in Indian patients (484-14).

5

A Phase III, Randomized, Multi-Center, Double-Blind, Global Study to Determine the efficacy and Safety of Durvalumab in Combination with and following Chemo radiotherapy Compared to Chemo radiotherapy Alone for Treatment in Women With Locally Advanced Cervical Cancer .CALLA (D9100C00001).

6

A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Transarterial Chemoembolization (TACE) in Combination with either Durvalumab Monotherapy or Durvalumab plus Bevacizumab Therapy in Patients with Locoregional Hepatocellular Carcinoma.EMERALD-1(D933GC00001).

7

A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/adjuvant Durvalumab for the Treatment of Patients with Resectable Stages II and III Non-small Cell Lung Cancer AEGEAN (D9106C00001).

8

A Randomized, Multiple-dose, Multicentre, Comparative, Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of Intravenous Infusion of Trastuzumab (Test, Hetero) and Reference Medicinal Product (Reference, Roche) in combination with standard chemotherapy in Patients of HER2-positive Metastatic breast cancer (TRUMAB Study)P5 – HCR/III/TRUMAB/05/2016.

9

A Multicentre, Open label, Balanced, Randomized, Two-treatment, Two-period, Single dose, Crossover, Bioequivalence study of Bortezomib for Injection 3.5 mg/vial of Dr. Reddy’s Laboratories Limited, India and VELCADE® (bortezomib) for Injection 3.5 mg/vial (Distributed and Marketed by: Millennium Pharmaceuticals, Inc., 40 Landsdowne Street, Cambridge, MA 02139) in previously untreated Multiple Myeloma and/or Relapsed Multiple Myeloma patients (17-VIN-0772).

10

A Prospective, Multicentre, Phase IV study to evaluate safety and efficacy of Dr. Reddy’s Bevacizumab (DRL_BZ) in Patients with Solid Tumours. (BZ-02-001).

11

A Prospective, Single arm, Multicentre, Post-marketing Study (Phase IV) to evaluate safety and efficacy of Dr. Reddy’s Trastuzumab (DRL_TZ) in Patients with HER2-Positive Cancer” (TZ-02-001).

12

A randomized, open label, two arm, single dose, crossover, bioequivalence study of Ayana Pharma’s Doxorubicin Hydrochloride liposome injection (lc-101) (Investigational Product) and the US reference standard Doxorubicin Hydrochloride liposome injection (Sun Pharma), in subjects with Ovarian Cancer(0384-18)

13

A Multicentre, Open Label, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Cross-Over, Study to Test for Bioequivalence between Celerity’s Doxorubicin Hydrochloride (Pegylated Liposomal) Injection 20 mg/10 mL (2 mg/mL) and the Reference Product, Caelyx® [Doxorubicin Hydrochloride(Pegylated Liposomal) Injection 20 mg/10 mL (2 mg/mL)] in Patients with Metastatic Breast Cancer (0927-17 )

14

A randomized, open label, two treatment, three period, three sequence, single dose, replicated crossover, bioequivalence study of doxorubicin hydrochloride liposome injection 2mg/ml (50mg/m2 dose) of sun pharmaceutical industries limited and caelyx (doxorubicin hydrochloride) liposome injection 2 mg/ml (50 mg/m2 dose) of janssen- cilag international nv, in patients with metastatic breast cancer/advanced ovarian cancer, under fed (standardized non high-fat meal) conditions

15

A randomised, doubleblind, placebocontrolled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemoradiotherapy in primary unresected patients with stage III, IVa, or IVb locoregionally advanced head and neck squamous cell carcinoma.

16

A multi-centre, randomized, open-label, single dose, two-treatment, three-period, three-sequence, partial replicate, crossover, pivotal bioequivalence study of Test capecitabine 500 mg tablet manufactured by Reliance Life Sciences Pvt. Ltd., India with Xeloda® (capecitabine 500 mg) manufactured by Roche Pharma AG, Germany in adult, human, cancer patients under fed condition.

17

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

18

Prospective, multi-centre, randomized, open label, two arm, parallel group, active control, comparative clinical study to evaluate efficacy, safety and Pharmacokinetics of R-TPR-023/AvastinTM when given intravenously in patients with Metastatic Colorectal Cancer

19

Protocol No: RLS/TP/2011/05 “ Prospective, Multi-centre, randomized, open label, two arm, parallel group, active-control, comparative clinical study to evaluate efficacy, safety and pharmacokinetics of R-TPR-0-16/Herceptin (Herclon) when given intravenously in patients with metastatic HER2-Overexpressing Breast Cancer

20

Protocol Title and No.: Prospective, multi-centric, open-label, two-arm, parallel group, active-control, randomized, comparative clinical study to evaluate efficacy and safety of R-TPR-017 / MabThera®(Ristova®) in patients with Non-Hodgkin’s Lymphoma (RLS/TP/2010/07)

21

Sandoz LAEP 06-302 – Sandoz Protocol LA-EP06-302: Pivotal study in breast cancer patients investigating efficacy and safety of LA-EP2006 and Neulasta®

22

AP311736: Adjuvant Axitinib treatment of Renal Cancer: A Randomized Double-blind Phase.3 study of Adjuvant Axitinib vs. Placebo in Subjects at High risk of Recurrent RCC.

23

Collection of blood samples from patients with primary or relapsed/refractory CD 20+ B cell Non Hodgkins Lymphoma for development and Bio analytical methods for BVX-20

24

A multinational, multicenter, randomized, double blind study comparing the Efficacy and safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism (VTE) in patients undergoing Major Abdominal Surgery.

25

Randomized, phase III-b, multi center, open label, parallel study of Enoxaparin given concomitantly with chemotherapy Vs Chemotherapy alone in patients with inoperable gastric and gastro-oesophageal cancer.

26

A Prospective, Randomized, Multiple-Dose, Multi-Center, Comparative, Parallel Clinical Study to Evaluate the Efficacy, Safety, Immunogenicity and Pharmacokinetics of an Intravenous Infusion of Bevacizumab (Test product, Hetero) and Reference Medicinal Product (Reference product, Roche) Administered in Combination with Standard Chemotherapy in Patients of Metastatic Colorectal Cancer.

27

A Prospective, Randomized, Multiple-Dose, Multi-Center, Comparative, Parallel Clinical Study to Evaluate the Efficacy, Safety, Immunogenicity and Pharmacokinetics of an Intravenous Infusion of Bevacizumab (Test product, Hetero) and Reference Medicinal Product (Reference product, Roche) Administered in Combination with Standard Chemotherapy in Patients of Metastatic Colorectal Cancer.

28

TevaPharma -Lotus –Study Title: An Open-Label, Multicentric, Randomized, Two Treatment, Three Period, Three Sequence, Semi-Replicate, Cross-over, Comparative Bioavailability Study of Doxorubicin Hydrochloride Liposomal Injection 20 mg/10mL (2mg/ml), concentrate for solution for infusion manufactured by Teva Pharmachemie, Netherlands with Caelyx 20 mg/10ml (2mg/ml) [Doxorubicin Hydrochloride Liposomal Injection], concentrate for solution for infusion of Janssen-CilagInternational NV, Belgium in advanced ovarian cancer and/or metastatic breast cancer patients under fasting condition. CT/DOX/1602.

29

Dr. Reddy’s – Lambda Study No.0076-17 –A multicenter, open label, randomized, two-treatment, two-period, two-sequence, single dose, cross-over bioequivalence study of Doxorubicin Hydrochloride (Pegylated liposomal) concentrate for solution for infusion 20 mg/10mL (2 mg/mL) of Dr. Reddy’s Laboratories Ltd, India, with that of Caelyx® 2mg/mL [Doxorubicin Hydrochloride (Pegylated Liposomal) concentrate for solution for infusion (20 mg/10mL)] of Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium in advanced ovarian cancer and/or metastatic breast cancer patients under fed condition.

30

Reference: Protocol no: CLR_16_13 – Sun Pharma Study Title: A randomized, open-label, two-period, single-dose, crossover, bioavailability study of paclitaxel injection concentrate for nano-dispersion (PICN) and Abraxane® in subjects with locally recurrent or metastatic breast cancer.

31

Intas -Lambda Therapeutic Research Ltd Study No.471-13-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 Anthracyclineand/or Taxane Chemotherapy.

32

A Randomized, Double-Blind, Multi-Centre, Parallel Group Study Comparing Two Humanized Monoclonal Antibodies That Target HER2 Receptors In Combination With Weekly Paclitaxel Administered As First-Line Treatment In Patients With HER2-Positive Metastatic Breast.

33

A randomized double-blind study in two parts • PartA – Comparing two humanized monoclonal antibodies that target VEGF in combination with mFOLFOX6 in patients with non-resectable metastatic colorectal cancer (mCRC) • PartB – Comparing two humanized monoclonal antibodies that target VEGF in combination with pemetrexed and carboplatin in recurrent or advanced non-squamous non-small cell lung cancer(NSCLC)

34

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

35

Multicenter, Double-Blind, Randomized, Parallel-Group Study to Assess the Efficacy and Safety ofMYL-1402O-3001 Compared with Avastin®, in the First-line Treatment of Patients with Stage IV Non-Squamous Non-Small cell Lung Cancer.

36

A Multicentre, Open label, Balanced, Randomized, Two-treatment, Two period, Single dose, Crossover, Bioequivalence study of Bortezomib for Injection 3.5 mg/vial of Dr. Reddy’s Laboratories Limited, India and VELCADE® (bortezomib) for Injection 3.5 mg/vial (Distributed and Marketed by: Millennium Pharmaceuticals, Inc., 40 Landsdowne Street, Cambridge, MA 02139) in previously untreated Multiple Myeloma and/or Relapsed Multiple Myeloma patients

37

A Prospective, single arm, multicentre study to assess safety and efficacy of Romy® (Romiplostim Powder for Injection) in patients with chronic refractory immune (idiopathic) thrombocytopenic purpura (ITP)

38

Study Title: A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide in addition to androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC).

39

A randomized, open label, multi-center, two-treatment, three-period, three-sequence, reference replicate, multiple dose, steady-state, bioequivalence (BE) study of Olaparib Tablets 150 mg (2*150 mg tablets) of Natco Pharma Limited with LYNPARZA® (Olaparib) tablets 150 mg (2*150 mg tablets) of AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, in male or female patients with ovarian cancer or breast cancer or prostate cancer.

40

Study Title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Active-Controlled, Two Part, Phase III, Global Study to Evaluate the Pharmacokinetics, Efficacy and Safety of BP02 (Trastuzumab) in comparison with Herceptin®-EU in Patients with HER2-Positive Early Breast Cancer (EBC) and HER2-Positive Metastatic Breast Cancer (MBC).

41

A Randomized, Active-Controlled, Multicenter, Open label, Two Arm Study to Assess Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics with Pegfilgrastim PFS of Intas Pharmaceutical Limited Compared with Neupogen® Injection in Paediatric Patients Under 6 years of Age with Rhabdomyosarcoma or Wilms’ Tumour on Myelosuppressive Chemotherapy (CmT) Regimen).

42

Study Title: Standard Chemotherapy versus Cancer Stem Cell Assay Directed Chemotherapy in Recurrent Platinum Resistant Ovarian Cancer.

43

A Multicenter, Randomised, Double blind, Parallel, Phase III Global Study to Assess the Efficacy and Safety of BP01 (Bevacizumab) when compared to Avastin®- EU in combination with Carboplatin and Paclitaxel during Induction phase and Bevacizumb alone during the Maintenance phase in patients with newly diagnosed or recurrent stage IIIB/IV Non Squamous (ns) Non Small Cell Lung Cancer (NSCLC).

44

A Phase IIb/III, Randomised, Double-blind, Placebo-controlled, Multicentre, Study of CA-170 in Combination with Chemotherapy in Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer (ASIAD-3)

45

A Phase 1, Open Label First In Human Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor GRC 54276 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Pembrolizumab or Anti-PD-L1 Atezolizumab in With Advanced Solid Tumors and Lymphomas.

46

Study Title: A global, multicenter, three arms, open-label randomized study to evaluate the efficacy 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.

47

Study Title: A phase III, two arm, multi centric, randomized, open label, parallel study to compare pharmacodynamics of Goserelin 10.8 mg Injection (Eurofarma Laboratórios S.A) administered subcutaneously with the reference drug ZOLADEX® 10.8 mg Injection (AstraZeneca) in patients with advanced prostate cancer.

48

“A Phase II Clinical Study to evaluate the efficacy and safety of NRC- 2694-A in patients with recurrent Head and Neck Squamous Cell Carcinoma”

49

A randomized, Controlled, open label, phase III study evaluating efficacy and safety of JDQ443 versus docetaxel in previously treated subjects with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer.

50

Protocol No: CR187-18 A Multicenter, Randomised, Double blind, Parallel, Phase III Global Study to Assess the Efficacy and Safety of BP01 (Bevacizumab) when compared to Avastin®- EU in combination with Carboplatin and Paclitaxel during Induction phase and Bevacizumb alone during the Maintenance phase in patients with newly diagnosed or recurrent stage IIIB/IV Non Squamous (ns) Non Small Cell Lung Cancer (NSCLC).

51

Protocol No: CA-170-302 A Phase IIb/III, Randomised, Double-blind, Placebo-controlled, Multicentre, Study of CA-170 in Combination with Chemotherapy in Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer (ASIAD-3)

52

Protocol No: CJDQ443B12301 KontRASt-02: A randomized, controlled, open label, phase III study evaluating the efficacy and safety of JDQ443 versus docetaxel in previously treated subjects with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer.

53

Protocol No. 1045-18 Study Title: A phase III, two arm, multi centric, randomized, open label, parallel study to compare pharmacodynamics of Goserelin 10.8 mg Injection (Eurofarma Laboratórios S.A) administered subcutaneously with the reference drug ZOLADEX® 10.8 mg Injection (AstraZeneca) in patients with advanced prostate cancer.

54

Protocol No. MW230015 Study Title: An open label, multi-center, randomized, two- treatment, two-period, two-sequence, two-way cross-over, single dose, Bioequivalence (BE) study with pharmacokinetic (PK) endpoints of Paclitaxel 100mg/vial injectable suspension at a dose of 260 mg/m2 of Anbison Lab, China with ABRAXANE® 100mg/vial for Injectable suspension at a dose of 260 mg/m2 of Celgene Corporation Summit, NJ 07901 in subject with metastatic Breast cancer after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy.