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.

To view trial experience by study phase or sponsor type, use the navigation to the left.

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 Solid tumors and lymphoma (first-in-human)

2

36

Full service United States
Phase I Solid tumors and lymphoma all comers (first-in-human)

3

30

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 IIIB Dental device

8

60

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

If you’d to talk to us about our experience or your study, contact us.