Phase 1
N=12
A Japanese Phase 1 Trial of c-Met Inhibitor MSC2156119J in Subjects With Solid Tumors
Solid Tumors
Bottom Line
View on ClinicalTrials.gov: NCT01832506 ↗Enrolled (actual)
12
Serious AEs
33.3%
Results posted
Dec 2016
Primary outcome: Primary: Number of Subjects Experiencing Dose Limiting Toxicity (DLT) — 0; 0; 0 subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MSC2156119J (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Experiencing Dose Limiting Toxicity (DLT) |
0; 0; 0 | — |
| SECONDARY Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs or TEAEs Leading To Death |
2; 3; 6; 0; 3; 1 | — |
| SECONDARY Number of Subjects With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score of 2 or Higher |
0; 0; 0 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J |
244.4; 301.3; 442.4 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J |
807.5; 610.1; 996.8 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J |
8.000; 8.017; 10.000 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J |
8.000; 9.917; 4.133 | — |
| SECONDARY Apparent Terminal Half-life (t1/2) of MSC2156119J |
— | — |
| SECONDARY Area Under the Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC[Inf]) of MSC2156119J |
— | — |
| SECONDARY Apparent Body Clearance (CL/f) of MSC2156119J |
— | — |
| SECONDARY Apparent Volume of Distribution Associated To The Terminal Phase (Vz/f) of MSC2156119J |
— | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time t (AUC0-t) After Single Dose of MSC2156119J |
4060.8; 5412.7; 8235.0 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time t (AUC0-t) After Multiple Dose of MSC2156119J |
16088.6; 13313.4; 21509.0 | — |
| SECONDARY Number of Subjects With Best Overall Response (BOR) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Clinical Benefit |
0; 0; 2 | — |
| SECONDARY Progression-free Survival (PFS) |
1.38 | — |
Summary
This is a Japanese multicenter, open-label, Phase 1 study to evaluate safety and efficacy of MSC2156119J in subjects with malignant solid tumor which is refractory to standard therapy or to which no effective standard therapy is applicable.
Eligibility Criteria
Inclusion Criteria
- A subject with a histologically or cytologically confirmed diagnosis of malignant solid tumor which is refractory to standard therapy or to which no effective standard therapy is applicable
- An archived tumor tissue is available or biopsy of tumor tissues can be newly performed
- A Japanese male or female, age greater than or equal to (>=) 20 years
- A subject who has read the Subject Information Sheet and understood the details of this clinical trial, and is willing and able to give his/her informed consent.
- A female of child-bearing potential must have a negative blood pregnancy test result at her screening period. A female subject of child-bearing potential must be willing to avoid pregnancy by using an adequate method of contraception Life expectancy is at least 3 months
- Other inclusion criteria apply
Exclusion Criteria
- Known Human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B
- Presence of liver fibrosis or liver cirrhosis that has been histologically diagnosed
- Signs or symptoms that suggest transmissible spongiform encephalopathy
- Received major surgery within 6 weeks before Day 1 in Cycle 1
- Known drug abuse or alcohol abuse
- Known hypersensitivity to any of the trial treatment ingredients
- Hematological test abnormalities
- Renal impairment as defined in the protocol
- Liver dysfunction as defined in the protocol
- History or presence of central nervous system metastasis
- History or presence of disease or condition that may hamper compliance or absorption of the investigational medicinal product (IMP) due to difficulty in swallowing or absorption
- Poor performance status of Eastern Cooperative Oncology Group Performance status (ECOG PS) >= 2
- Received any anti-cancer therapy days Received extensive prior radiotherapy that irradiates more than 30 percent of bone marrow
- Received any radiotherapy within 4 weeks before Day 1 in Cycle 1
- Pregnancy and lactation period
- History of receiving treatment with any c-Met signaling pathway inhibitor
- Participation in another interventional clinical trial within the past 30 days from Day 1 in Cycle 1
- Other significant disease that in the Investigator's opinion would exclude the subject from the trial
- Legal incapacity or limited legal capacity
- Other exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT01832506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.