ZD4054 (Zibotentan) Phase II Non-Small Cell Lung Cancer Study

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Lung Cancer; Non Small Cell Lung Cancer

Treatments: Drug: Pemetrexed; Drug: ZD4054; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00745875

D4320C00035

Details and patient eligibility

About

The aim of this study is to collect initial efficacy and safety data on the use of a new treatment ZD4054 (Zibotentan) when used in combination with pemetrexed (a standard chemotherapy agent) for the treatment of non-small cell lung cancer compared to treatment with pemetrexed alone

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed locally advanced or metastatic NSCLC on entry into study suitable for pemetrexed therapy
• Patients that meet one of the following criteria: - progressed following one prior platinum-based chemotherapy regimen for locally advanced or metastatic disease; -progressed within 6 months of adjuvant platinum-based chemotherapy
• Life expectancy of > 12 weeks

Exclusion criteria

• Prior treatment with pemetrexed in the last 12 months.
• Prior therapy with an ET receptor antagonist
• Any recent surgery, unhealed surgical incision, severe concomitant medical condition (eg, unstable cardiac, hepatic or renal disease) or significant laboratory finding which makes it undesirable for the patient to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

ZD4054 + Pemetrexed

Treatment:

Drug: ZD4054

Drug: Pemetrexed

2

Placebo Comparator group

Description:

ZD4054 matched placebo + pemetrexed

Treatment:

Drug: Placebo

Drug: Pemetrexed