First-in-Man, Dose-escalation Trial of c-Met Kinase Inhibitor EMD 1204831 in Subjects With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT01110083 |
Recruitment Status :
Terminated
(Please see "Purpose" statement below.)
First Posted : April 26, 2010
Last Update Posted : October 22, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumors | Drug: EMD 1204831 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Open-label, Non-randomized, Dose-escalation First-in-man Trial to Investigate the c-Met Kinase Inhibitor EMD 1204831 in Subjects With Advanced Solid Tumors |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | March 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm 1 |
Drug: EMD 1204831
Subjects will receive EMD 1204831 twice a day for 21 days during each treatment cycle |
- To determine the maximum tolerated dose (MTD) of EMD 1204831 in subjects with advanced solid tumors [ Time Frame: After first cycle of treatment ]
- Number and frequency of adverse events, and changes from baseline in laboratory values, vital signs and ECGs will be used to assess safety and tolerability of EMD1204831. [ Time Frame: Scheduled visits throuhout each 21 day cycle of treatment. Subjects may continue to receive cycles of EMD 1204831 until disease progression or unacceptable toxicity. ]
- Anti-tumor activity and best overall response will be assessed according to RECIST 1.0 after every two cycles of EMD 1204831. Frequency of subjects with different levels of overall response (CR, PR, SD or PD) and best Overall Response will be presented. [ Time Frame: Scheduled visits throuhout each 21 day cycle of treatment. Subjects may continue to receive cycles of EMD 1204831 until disease progression or unacceptable toxicity. ]
- PK parameters will be assessed to characterize the pharmacokinetic (PK) profile of EMD 1204831 and summarized by dose level and cycle. [ Time Frame: Scheduled visits throuhout each 21 day cycle of treatment. Subjects may continue to receive cycles of EMD 1204831 until disease progression or unacceptable toxicity. ]
- Values and changes over time in pharmacodynamic (Pd) markers in tissue and molecular markers in blood will be assessed [ Time Frame: Scheduled visits throuhout each 21 day cycle of treatment. Subjects may continue to receive cycles of EMD 1204831 until disease progression or unacceptable toxicity. ]
- Exploratory analyses of genes that may be involved in the absorption, distribution, metabolism, and elimination (ADME) of EMD 1204831 will be performed. [ Time Frame: Scheduled visits throuhout each 21 day cycle of treatment. Subjects may continue to receive cycles of EMD 1204831 until disease progression or unacceptable toxicity. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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)
Exclusion Criteria:
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110083
United States, Texas | |
M.D. Anderson Cancer Center | |
Houston, Texas, United States |
Study Director: | Manfred Klevasath, MD | Merck KGaA, Darmstadt, Germany |
Responsible Party: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT01110083 |
Other Study ID Numbers: |
EMR200096-001 |
First Posted: | April 26, 2010 Key Record Dates |
Last Update Posted: | October 22, 2013 |
Last Verified: | October 2013 |
Phase 1 advanced solid tumors refractory to standard therapy Patients with solid tumors, either refractory to standard therapy or for which no effective standard therapy is available |
Neoplasms |