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A Phase I Open-label, Non-randomized, Dose-escalation First-in-man Trial to Investigate the c-Met Kinase Inhibitor EMD 1214063 Under Two Different Regimens in Subjects With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Patients With Solid Tumors, Either Refractory to Standard Therapy or for Which no Effective Standard Therapy is Available

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Trial Information

A Phase I Open-label, Non-randomized, Dose-escalation First-in-man Trial to Investigate the c-Met Kinase Inhibitor EMD 1214063 Under Two Different Regimens in Subjects With Advanced Solid Tumors


Inclusion Criteria:



1. Subject should read and fully understand the requirements of the trial, be willing to
comply with all trial visits and assessments, and be willing and able to give
informed consent

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

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

4. Estimated life expectancy > three months

5. Men or women aged ≥ 18 years

6. Women of childbearing potential must have a negative blood pregnancy test at the
Screening Visit. For this trial, women of childbearing potential are defined as all
women after puberty, unless they are post-menopausal for at least 12 months, are
surgically sterile, or are sexually inactive.

7. Subjects and their partners must be willing to avoid pregnancy during the trial and
until three months after the last trial treatment. Male subjects with female partners
of childbearing potential and female subjects of childbearing potential must,
therefore, be willing to use adequate contraception as approved by the investigator,
such as a two-barrier method or one-barrier method with spermicide or intrauterine
device. This requirement begins two weeks before receiving the first trial treatment
and ends one month after receiving the last treatment.

8. ECOG performance status of 0 to 2

9. Adequate hematological function:

- Hemoglobin ≥ 9.0 g/dL

- Neutrophils > 1.5 x 109/L

- Platelets ≥ 75 x 109/L

10. 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 x ULN

11. Adequate renal function:

- Serum creatinine < 1.5 x ULN, and/or

- Calculated creatinine clearance > 60 mL/min

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

13. Recovery from any surgical intervention

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

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. Known HIV positivity, active hepatitis C, or active hepatitis B

5. Medical history of liver fibrosis/ cirrhosis

6. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family
members who suffer(ed) from such

7. Medical history of difficulty swallowing, malabsorption or other chronic
gastrointestinal disease, or conditions that may hamper compliance and/or absorption
of the tested product

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

9. Impaired cardiac function (left ventricular ejection fraction < 45% defined by
echocardiograph, serious arrhythmia, unstable angina pectoris, congestive heart
failure NYHA III and IV, myocardial infarction within the last 12 months prior to
trial entry; signs of pericardial effusion)

10. Hypertension uncontrolled by standard therapies (not stabilized to 150/90 mm Hg)

11. Peripheral neuropathy Grade ≥ 2

12. Medical history of any other significant medical disease, major surgery, or
psychiatric condition that might impair the subject's well being or preclude full
participation in the trial

13. Women who are pregnant or nursing

14. Known drug abuse or alcohol abuse

15. Participation in another clinical trial within the past 28 days

16. Requires concurrent treatment with a non-permitted drug

17. Known hypersensitivity to any of the trial treatment ingredients

18. Legal incapacity or limited legal capacity

19. Any other reason that, in the opinion of the principal investigator, precludes the
subject from participating in the trial

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD) of EMD 1214063 for each of two treatment regimens in subjects with advanced solid tumors

Outcome Time Frame:

After first cycle of treatment

Safety Issue:

No

Principal Investigator

Manfred Klevasath, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merck KGaA

Authority:

United States: Food and Drug Administration

Study ID:

EMR200095_001

NCT ID:

NCT01014936

Start Date:

November 2009

Completion Date:

Related Keywords:

  • Patients With Solid Tumors, Either Refractory to Standard Therapy or for Which no Effective Standard Therapy is Available
  • Phase 1
  • advanced solid tumors
  • refractory to standard therapy
  • Neoplasms

Name

Location

M.D. Anderson Cancer CenterHouston, Texas  77030