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A Phase I Multicenter, Open-Label, Dose Escalation Trial of AS703569 Given Orally to Subjects With Solid Tumours


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

A Phase I Multicenter, Open-Label, Dose Escalation Trial of AS703569 Given Orally to Subjects With Solid Tumours


Inclusion Criteria:



1. Histopathologically confirmed locally advanced or metastatic solid tumour that is
either refractory after standard of care therapy for the disease or for which
standard of care therapy is not reliably effective or has a cancer for which no
standard therapy exists

2. Age greater than or equal to 18 years

3. Has read and understands the informed consent form and is willing and able to give
informed consent, and subject authorization under Health Insurance Portability and
Accountability Act (HIPAA). Fully understands requirements of the study and willing
to comply with all study visits and assessments

4. Subjects and their partners must be willing to avoid pregnancy during the study and
until 1 month after the last study drug administration. Males with female partners of
childbearing potential and female subjects of childbearing potential must therefore
be willing to use adequate contraception such as, intra uterine device, diaphragm, or
condom, for the duration of the study. For the purposes of this study, childbearing
potential is defined as: "All female subjects unless they are post- menopausal for at
least two years, are surgically sterile or sexually inactive"

5. Negative serum pregnancy test at the screening visit for women of childbearing
potential

Exclusion Criteria:

1. Bone marrow impairment as evidenced by Hb < 9.0 g/dl, ANC < 1.5x 109/L, platelets <
75 x 109/L. Subjects may be transfused.

2. Renal impairment as evidenced by serum creatinine > 1.5 x ULN (upper limit of
normal), and/or calculated creatinine clearance < 60 ml/min

3. Liver function abnormality as defined by total bilirubin > 1.5 ULN, or AST or ALT >
2.5x ULN at screening; for subjects with liver involvement AST or ALT > 5x ULN at
screening

4. INR (blood coagulation) > 1.5 x ULN for subjects not on therapeutic doses of
coumadin

5. History of CNS metastases, unless subject has been previously treated for CNS
metastases, is stable by CT scan without evidence of cerebral edema, and has no
requirements for corticosteroids or anticonvulsants

6. History of difficulty swallowing, malabsorption or other chronic gastro- intestinal
disease or conditions that may hamper compliance and/or absorption of the tested
product

7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) > 2

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

9. Has received chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or any
other anticancer therapy or surgical intervention within 28 Days of Day 1 of study
drug treatment (6 weeks for nitrosureas or mitomycin C), and must have fully
recovered

10. Has received extensive prior radiotherapy on more than 30% of bone marrow reserves,
or prior bone marrow/stem cell transplantation

11. Has received any investigational agent within 28 days of Day 1

12. Has history of any other significant medical disease or intervention including major
gastric or small bowel surgery or has a psychiatric condition that might impair the
subjects well-being or preclude full participation in the study

13. Is a pregnant or nursing female

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:

Number and proportion of subjects experiencing: at least a Dose-Limiting Toxicity (DLT) in each cohort during the first cycle.

Outcome Time Frame:

Undefined

Safety Issue:

No

Principal Investigator

Narmyn Rejeb, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merck Serono S.A., Geneva

Authority:

United States: Food and Drug Administration

Study ID:

26865

NCT ID:

NCT00391521

Start Date:

August 2006

Completion Date:

June 2010

Related Keywords:

  • Solid Tumors
  • Oncology. All solid Tumour disease.
  • Neoplasms

Name

Location

EMD Serono Medical Information OfficeRockland, Massachusetts  02370