- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00391521
AS703569 Phase I in Patients With Solid Tumours
January 29, 2014 updated by: EMD Serono
A Phase I Multicenter, Open-Label, Dose Escalation Trial of AS703569 Given Orally to Subjects With Solid Tumours
This is a Phase I trial.
Some specific protocol information is proprietary and is not publicly available at this time.
Full information will be provided to trial participants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
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Rockland, Massachusetts, United States, 02370
- EMD Serono Medical Information Office
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- Age greater than or equal to 18 years
- 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
- 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"
- Negative serum pregnancy test at the screening visit for women of childbearing potential
Exclusion Criteria:
- 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.
- Renal impairment as evidenced by serum creatinine > 1.5 x ULN (upper limit of normal), and/or calculated creatinine clearance < 60 ml/min
- 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
- INR (blood coagulation) > 1.5 x ULN for subjects not on therapeutic doses of coumadin
- 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
- History of difficulty swallowing, malabsorption or other chronic gastro- intestinal disease or conditions that may hamper compliance and/or absorption of the tested product
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) > 2
- Known HIV, hepatitis C, or hepatitis B positivity
- 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
- Has received extensive prior radiotherapy on more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation
- Has received any investigational agent within 28 days of Day 1
- 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
- Is a pregnant or nursing female
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Regimen 1
|
Regimen 1: 3 mg/m2 /day given orally on Days 1 and 8 during a 21-day cycle
Other Names:
Regimen 2: 2 mg/m2/day given orally on Days 1, 2, and 3 of a 21-day cycle
Other Names:
Regimen 3: 10 mg/m2/day given orally on Days 1, 2, 3 and Days 8, 9, 10 of a 21-day cycle
Other Names:
|
Active Comparator: 2
Regimen 2
|
Regimen 1: 3 mg/m2 /day given orally on Days 1 and 8 during a 21-day cycle
Other Names:
Regimen 2: 2 mg/m2/day given orally on Days 1, 2, and 3 of a 21-day cycle
Other Names:
Regimen 3: 10 mg/m2/day given orally on Days 1, 2, 3 and Days 8, 9, 10 of a 21-day cycle
Other Names:
|
Active Comparator: 3
Regimen 3
|
Regimen 1: 3 mg/m2 /day given orally on Days 1 and 8 during a 21-day cycle
Other Names:
Regimen 2: 2 mg/m2/day given orally on Days 1, 2, and 3 of a 21-day cycle
Other Names:
Regimen 3: 10 mg/m2/day given orally on Days 1, 2, 3 and Days 8, 9, 10 of a 21-day cycle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number and proportion of subjects experiencing: at least a Dose-Limiting Toxicity (DLT) in each cohort during the first cycle.
Time Frame: Undefined
|
Undefined
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma and urine PK parameters of AS703569, genetic markers and potential markers of clinical and biological response.
Time Frame: Undefined
|
Undefined
|
Number and proportion of subjects with Progressive Disease as assessed at the end of every other cycle.
Time Frame: Undefined
|
Undefined
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Narmyn Rejeb, MD, Merck Serono S.A., Geneva
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
October 20, 2006
First Submitted That Met QC Criteria
October 23, 2006
First Posted (Estimate)
October 24, 2006
Study Record Updates
Last Update Posted (Estimate)
January 30, 2014
Last Update Submitted That Met QC Criteria
January 29, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26865
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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