Study identifier:D2785C00002
ClinicalTrials.gov identifier:NCT00733031
EudraCT identifier:N/A
CTIS identifier:N/A
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
cancer,
Phase 1
No
AZD6918, gemcitabine, pemetrexed
All
75
Interventional
18 Years +
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 May 2025 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
-
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.
Location
Location
Nashville, TN, United States
Location
Aurora, CO, United States
Arms | Assigned Interventions |
---|---|
Experimental: gemcitabine gemcitabine administered in combination with AZD6918 | Drug: gemcitabine intravenous, doses are on an intermittent schedule Other Name: Gemzar |
Experimental: pemetrexed pemetrexed administered in combination with AZD6918 | Drug: pemetrexed intravenous, dose administered every 21-days Other Name: Alimta |
Experimental: AZD6918 AZD6918 administered alone | Drug: AZD6918 liquid suspension, daily, oral dose |
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