Overview

First-in-Man, Dose-escalation Trial of c-Met Kinase Inhibitor EMD 1204831 in Subjects With Advanced Solid Tumors

Status:
Terminated

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

Summary

EMD Serono has closed enrollment into this trial prior to determination of maximum tolerated dose (MTD). EMD Serono has decided not to pursue the development of EMD 1204831 in patients with advanced solid tumors for reasons other than safety.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

EMD Serono

Criteria

Inclusion Criteria:

Main Inclusion Criteria

1. Histologically or cytologically confirmed solid tumor, either refractory standard
therapy or for which no effective standard therapy is available

2. Measurable or evaluable disease, as defined by RECIST 1.0

3. Men or women aged ≥ 18 years

4. ECOG performance status of 0 to 2

5. Adequate hematological function: Hemoglobin ≥ 9.0 g/dL; Neutrophils > 1.5 x 109/L;
Platelets ≥ 100 x 109/L

6. Adequate liver function: Total bilirubin ≤ 1.5 x ULN; AST/ ALT ≤ 2.5 x ULN

7. For subjects with liver metastases: Total bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 5 ULN

8. Adequate renal function: Serum creatinine < 1.5 x ULN, and/or Calculated creatinine
clearance > 60 mL/min

9. Resolution of all acute chemotherapy, radiotherapy or surgery-related AEs to Grade ≤1,
except for alopecia

10. Recovery from any surgical intervention

11. Subjects enrolling after the MTD has been determined must present specific c-Met
alterations (overexpression, amplification, mutation)

Exclusion Criteria:

Main Exclusion Criteria

1. Received chemotherapy, immunotherapy, hormonal therapy (except subjects with prostate
cancer), biologic therapy, or any other investigational agent or anticancer therapy
within 28 days (or five half-lives for non-cytotoxics, whichever is shorter), of Day 1
of trial treatment (six weeks for nitrosureas or mitomycin C)

2. Received extensive prior radiotherapy on more than 30% of bone marrow

3. Symptomatic primary tumors or metastasis of brain and/or central nervous system,
uncontrolled with antiepileptics and requiring high doses of steroids

4. Medical history of liver fibrosis/ cirrhosis

5. Medical history of surgery within six weeks prior to enrollment

6. Neuropathy Grade ≥ 2

7. Requires concurrent treatment with a non-permitted drug

8. Absence or abnormal pupillary reflex