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R763 Phase I in Patients With Solid Tumours
This study is currently recruiting participants.
Verified by EMD Serono, March 2009
First Received: October 20, 2006   Last Updated: March 21, 2009   History of Changes
Sponsored by: EMD Serono
Information provided by: EMD Serono
ClinicalTrials.gov Identifier: NCT00391521
  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: R763
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: R 763
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: A Phase I Multicenter, Open-Label, Dose Escalation Trial of R763 Given Orally to Subjects With Solid Tumours

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: Yes ]

Secondary Outcome Measures:
  • Plasma and urine PK parameters of R763, genetic markers and potential markers of clinical and biological response. 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 ]

Estimated Enrollment: 108
Study Start Date: August 2006
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Regimen 1
Drug: R763
Regimen 1 subjects will be dosed on Days 1 and 8 of a 21 day cycle according to the dose escalation scheme
2: Active Comparator
Regimen II
Drug: R763
Regimen 2 subjects will be dosed on Days 1, 2 and 3 of a 21 day cycle according to the dose escalation scheme

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

Contacts
Contact: Local Medical Information Office 888-275-7376

Locations
United States, Massachusetts
EMD Serono Med Info Recruiting
Rockland, Massachusetts, United States, 02370
Contact: Susan Fischer     781-681-2506        
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Narmyn Rejeb, MD Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany
  More Information

No publications provided

Responsible Party: EMD Serono ( Sue Fischer, Clinical Project Manager )
Study ID Numbers: 26865
Study First Received: October 20, 2006
Last Updated: March 21, 2009
ClinicalTrials.gov Identifier: NCT00391521     History of Changes
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 07, 2009