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AS703569 Phase I in Patients With Solid Tumours

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00391521
First received: October 20, 2006
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Solid Tumors
Drug: AS703569
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Number and proportion of subjects experiencing: at least a Dose-Limiting Toxicity (DLT) in each cohort during the first cycle. [ Time Frame: Undefined ] [ Designated as safety issue: No ]

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

Enrollment: 104
Study Start Date: August 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391521

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

Publications:
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00391521     History of Changes
Other Study ID Numbers: 26865
Study First Received: October 20, 2006
Last Updated: January 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by EMD Serono:
Oncology. All solid Tumour disease.

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014