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

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Cancer,; Solid Tumors; Advanced Solid Malignancies

Treatments: Drug: gemcitabine; Drug: AZD6918; Drug: pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00733031

D2785C00002

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

gemcitabine

Experimental group

Description:

gemcitabine administered in combination with AZD6918

Treatment:

Drug: gemcitabine

pemetrexed

Experimental group

Description:

pemetrexed administered in combination with AZD6918

Treatment:

Drug: pemetrexed

AZD6918

Experimental group

Description:

AZD6918 administered alone

Treatment:

Drug: AZD6918