Trial Experience

Clinical Trial Experience

The following table lists the current study experience of the Medelis team, including phase I,

phase II, phase III, rescue studies and oncology bioequivalence studies.

Study Indication Sites Patients Services* Countries
Phase I Solid tumors – all comers

1

6

 Full service United States
Phase I Solid tumors – all comers

3

32

 Full service United States
Phase I Metastatic liver cancer- image guided surgery system

1

14

 Full service United States
Phase I Non-Hodgkin’s lymphoma

4

36

 Full service United States & Switzerland
Phase I Chronic lymphocytic leukemia

4

36

 Full service United States
Phase I Multiple myeloma

4

36

 Full service United States
Phase I Chronic lymphocytic leukemia

4

24

 Full service United States
Phase I BE Myelodysplastic syndrome

12

36

 Full service United States & France
Phase I/II Acute myelogenous leukemia and myelodysplastic syndrome

3

33

 IND submission, regulatory consulting United States
Phase I/II Small cell lung cancer

15

110

 Full service Spain, UK, Canada & United States
Phase II Metastatic liver cancer – image guided surgery system

3

75

 Full service United States
Phase II Metastatic liver cancer – image guided surgery system

2

60

 Full service United States
Phase II Metastatic liver cancer – image guided surgery system

2

32

 Medical Monitoring/DSMB United States
Phase II Recurrent epithelia ovarian cancer

5

40

 Full service Unites States
Phase II Advanced sarcoma

4

36

 PM/CM United States
Phase II Advanced multiple myeloma

7

60

 PM/CM United States
Phase II Malignant ascites in ovarian cancer patients

13

39

 Full service United States
Phase II Advanced ovarian cancer

12

47

 Full service United States
Phase II Non-small cell lung cancer

8

210

 Full service United States
Phase II Locally advanced pancreatic cancer

10

40

 Start-up/CM/PM Canada, United States
Phase II Breast cancer with progression of previously irradiated brain metastases

8

31

 Start-up/patient recruitment United States
Phase II Metastatic colorectal

4

33

 PM/CM United States
Phase II Idiopathic thrombocytopenic purpura (ITP)

40

80

 Feasibility assessment/start-up United States
Phase III Lung transplantation

21

240

 Full service Australia, Austria, United States
Phase III Non-small cell lung cancer (Stage IIIb/IV) – first line

103

1,200

 Clinical data review/SAE narratives United States
Phase III Non-small cell lung cancer (Stage IIIb/IV) – second line

140

900

 Clinical data review/SAE narratives United States
Phase III Chronic myelogenous leukemia

103

642

 Clinical data review United States
Phase III Chronic myelogenous leukemia –chronic phase

140

771

 Independent, unblinded clinical data review United States
Phase III Unresectable or metastatic GIST

121

736

 Independent, unblinded clinical data review United States
Phase I/II Small Cell Lung Cancer

11

120

 Full service United States / UK / Spain
Phase I Myelodysplastic Syndrome

10

32

 Full service United States / Europe
Phase III Acute Myeloid Leukemia (AML) and Acute Lymphoid Leukemia (ALL) Patients

25

160

 Full service United States
Phase II Metastatic Pancreatic Adenocarcinoma

10

120

 Full service United States
Phase I Non-Hodgkin Lymphoma

4

64

 Full service United States / Switzerland
Phase I Solid tumors

4

86

 Full service United States
Phase III Patient Profile and Data Cleaning Activities Patient Profile and Data Cleaning Activities
Phase II Bladder cancer

4

6

 Full Service United States
Phase I Solid tumors – all comers

5

50

 Full Service United States
Phase I Pancreatic, Colorectal and Refractory GI Adenocarcinoma

6

48

 Full Service United States
Phase IB Malignant Pleural Mesothelioma

5

60

 Monitoring/Safety United States
Phase I/II Solid Tumors

4

18

 Full Service United States
Phase III Patient Profile and Data Cleaning Activities Patient Profile and Data Cleaning Activities
Phase I Oral Mucositis

4

80

 Full Service United States
Phase II Non-Hodgkin Lymphoma

4

75

 Full Service United States
Phase I Hematological Cancer

10

48

 Full Service United States / Europe
Phase II NSCLC

6

120

 Full Service United States / Europe
Phase IB Non-muscle Invasive Bladder Cancer

1

9

 Full Service Canada
Phase I Multiple Myeloma

3

24

 Full Service United States
Phase I Metastatic microsatellite stable Colon Cancer, Metastatic Squamous Histology Head and Neck Cancer, and Metastatic Non-Small Cell Lung Cancer

5

72

 Full Service United States
Phase I Advanced Relapsed and Refractory Multiple Myeloma

2

30

 Full Service United States
Phase I Prostate

7

52

 Full Service United States
Phase I Adenocarcinoma Peritoneal Metastases

2

9

 Full Service United States
Phase III oGVHD

12

60

 Full Service United States
Phase I/II Adult patients with moderate to severe DED secondary to GVHD following allogeneic stem cell transplantation (ASCT)

4

60

 Full Service United States
Phase I Refractory Hematologic Malignancies or Solid Tumors

3

18

 Full Service United States
Phase III Superficial Basal Cell Carcinoma

12

186

 Full Service United States
European Operations
Phase I Solid Tumor

2

35

 Full service UK, Holland
Phase I Solid Tumor

1

24

 Full service UK
Phase I Solid Tumor

2

16

 Full service UK, Holland
Phase I Solid Tumor

2

14

 Full service UK, Holland
Phase I Chronic lymphocytic leukemia

1

24

 Full service Holland
Phase I Chronic lymphocytic leukemia

4

36

 Full service Sweden, UK, Germany
Phase II Chronic lymphocytic leukemia

1

20

 Full service UK
Phase II Chronic lymphocytic leukemia

20

60

 Feasibility assessment UK, France, Denmark, Sweden, Poland
Phase II Non-small cell lung cancer

4

13

 Full service UK
Phase II Pediatric ALL

25

100

 Feasibility assessment France, UK, Netherlands, Belgium
Phase III Breast cancer

4

16

 Full service UK
Phase III Melanoma

1

35

 Full service UK
Phase III Colorectal

21

363

 Full service UK, Poland, Denmark
Phase III Colorectal

10

60

 Full service UK, Poland, Denmark
Phase III Non-small cell lung cancer

5

50

 Full service UK
Phase III Gliomas

30

150

 Full service UK, Denmark, France, Germany
Phase III Hematological Malignancies

4

40

 Full service Sweden, UK
Phase III Head & Neck Cancer

25

500

 Full Service UK, Germany, France

 


Experience

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