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

Stopped early · Phase 1

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID

NCT01110083

Run by

EMD Serono

People needed

38

Starts

2010-04-01

Last updated by the study team

2013-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Main Inclusion Criteria
• Histologically or cytologically confirmed solid tumor, either refractory standard therapy or for which no effective standard therapy is available
• Measurable or evaluable disease, as defined by RECIST 1.0
• Men or women aged ≥ 18 years
• ECOG performance status of 0 to 2
• Adequate hematological function: Hemoglobin ≥ 9.0 g/dL; Neutrophils > 1.5 x 109/L; Platelets ≥ 100 x 109/L
• Adequate liver function: Total bilirubin ≤ 1.5 x ULN; AST/ ALT ≤ 2.5 x ULN
• For subjects with liver metastases: Total bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 5 ULN
• Adequate renal function: Serum creatinine < 1.5 x ULN, and/or Calculated creatinine clearance > 60 mL/min
• Resolution of all acute chemotherapy, radiotherapy or surgery-related AEs to Grade ≤1, except for alopecia
• Recovery from any surgical intervention
• Subjects enrolling after the MTD has been determined must present specific c-Met alterations (overexpression, amplification, mutation)

You may not qualify if…

• Main Exclusion Criteria
• 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)
• Received extensive prior radiotherapy on more than 30% of bone marrow
• Symptomatic primary tumors or metastasis of brain and/or central nervous system, uncontrolled with antiepileptics and requiring high doses of steroids
• Medical history of liver fibrosis/ cirrhosis
• Medical history of surgery within six weeks prior to enrollment
• Neuropathy Grade ≥ 2
• Requires concurrent treatment with a non-permitted drug
• Absence or abnormal pupillary reflex

Where it is running

• M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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