Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918

Phase 1

Terminated

• Conditions: Cancer,; Solid Tumors; Advanced Solid Malignancies
• Interventions: Drug: AZD6918; Drug: gemcitabine; Drug: pemetrexed

• Registration Number: NCT00733031
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-08
• Study First Submitted QC: 2008-08-11
• Study First Posted: 2008-08-12
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-09
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZD6918	AZD6918	AZD6918 administered alone
gemcitabine	gemcitabine	gemcitabine administered in combination with AZD6918
pemetrexed	pemetrexed	pemetrexed administered in combination with AZD6918

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Nashville, Tennessee, United States