Solid Tumors Clinical Trial
Official title:
A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6918 Administered Daily as a Single Agent and in Combination Treatment in Adult Patients With Refractory Solid Malignancies
| Verified date | December 2010 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918 will be administered twice daily. Then maximum tolerated doses in combination with either gemcitabine or pemetrexed will also be investigated.
| Status | Terminated |
| Enrollment | 75 |
| Est. completion date | March 2009 |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Advanced solid tumors for which standard treatment does not exist or is no longer effective. - For chemotherapy combination treatment, must be suitable for treatment with either gemcitabine or pemetrexed. - Relatively good overall health other than cancer. Exclusion Criteria: - Poor bone marrow function (not producing enough blood cells). - Poor liver or kidney function. - Serious heart conditions - History of uncontrolled epilepsy, Parkinson's disease, Alzheimer's disease, brain tumor or any uncontrolled psychiatric or nervous system condition |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Aurora | Colorado |
| United States | Research Site | Nashville | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, Karnofsky performance status | Weekly for first two treatment cycles, then every 2-4 weeks | Yes | |
| Secondary | Pharmacokinetic effect of AZD6918 when administered alone and in combination with chemotherapy | According to protocol specified schedule, the number of PK samples collected during Cycle 1 (up to 28 days) based on treatment with AZD6918 alone or in combination with chemotherapy | Yes |
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