Status:
ACTIVE_NOT_RECRUITING
Phase I Comparative Bioavailability Study
Lead Sponsor:
AstraZeneca
Conditions:
Solid Tumors
Eligibility:
All Genders
18-130 years
Phase:
PHASE1
Brief Summary
The purpose of this phase I randomised cross over study is to determine and compare the bioavailability of two different oral formulations of AZD2281 in advanced solid tumour cancer patients
Eligibility Criteria
Inclusion
- Histologically confirmed malignant advanced solid tumour, which is refractory to standard therapies (except Group 8 patients who must not be platinum refractory) or for which no suitable effective standard therapy exists
- Patients must have adequate organ and bone marrow function measured within 7 days prior to administration of study treatment
- Female patients must have evidence of non-child bearing status: negative urine or serum pregnancy test within 7 days of study treatment for women of child bearing, or postmenopausal status
Exclusion
- Patients receiving chemotherapy, radiotherapy (except for palliative reasons) or any other anti-cancer therapy within 4 weeks of the last dose prior to study entry. Patients may continue the use of biphosphonates for bone metastases and corticosteroids
- Patients with symptomatic uncontrolled brain metastases
- Major surgery within 2 weeks of starting study and patients must have recovered from any effects of any major surgery
- Patients who are platinum refractory (Group 8 only)
- Patients with myelodysplastic syndrome/acute myeloid leukaemia (Group 8 only).
Key Trial Info
Start Date :
October 27 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT00777582
Start Date
October 27 2008
End Date
March 31 2025
Last Update
March 12 2025
Active Locations (10)
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1
Research Site
Randwick, Australia, 2031
2
Research Site
Leuven, Belgium, 3000
3
Research Site
Bellinzona, Switzerland, CH-6500
4
Research Site
Edinburgh, United Kingdom, EH4 2XR