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AS703569 Phase I in Patients With Solid Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00391521
Recruitment Status : Completed
First Posted : October 24, 2006
Last Update Posted : January 30, 2014
Information provided by (Responsible Party):
EMD Serono

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: AS703569 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Multicenter, Open-Label, Dose Escalation Trial of AS703569 Given Orally to Subjects With Solid Tumours
Study Start Date : August 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Active Comparator: 1
Regimen 1
Drug: AS703569
Regimen 1: 3 mg/m2 /day given orally on Days 1 and 8 during a 21-day cycle
Other Names:
  • MSC1992371A
  • Aurora kinase inhibitor

Active Comparator: 2
Regimen 2
Drug: AS703569
Regimen 2: 2 mg/m2/day given orally on Days 1, 2, and 3 of a 21-day cycle
Other Names:
  • MSC1992371A
  • Aurora kinase inhibitor

Active Comparator: 3
Regimen 3
Drug: AS703569
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:
  • MSC1992371A
  • Aurora kinase inhibitor

Primary Outcome Measures :
  1. Number and proportion of subjects experiencing: at least a Dose-Limiting Toxicity (DLT) in each cohort during the first cycle. [ Time Frame: Undefined ]

Secondary Outcome Measures :
  1. Plasma and urine PK parameters of AS703569, genetic markers and potential markers of clinical and biological response. [ Time Frame: Undefined ]
  2. Number and proportion of subjects with Progressive Disease as assessed at the end of every other cycle. [ Time Frame: Undefined ]

Information from the National Library of Medicine

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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:

  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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00391521

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United States, Massachusetts
EMD Serono Medical Information Office
Rockland, Massachusetts, United States, 02370
Sponsors and Collaborators
EMD Serono
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Study Director: Narmyn Rejeb, MD Merck Serono S.A., Geneva

Publications of Results:
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Responsible Party: EMD Serono Identifier: NCT00391521     History of Changes
Other Study ID Numbers: 26865
First Posted: October 24, 2006    Key Record Dates
Last Update Posted: January 30, 2014
Last Verified: January 2014
Keywords provided by EMD Serono:
Oncology. All solid Tumour disease.
Additional relevant MeSH terms:
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