Phase 2
Completed N=66
ZD4054 (Zibotentan) Phase II Non-Small Cell Lung Cancer Study
Source: ClinicalTrials.gov NCT00745875 ↗Enrolled (actual)
66
Serious AEs
16.7%
Results posted
Jun 2012
Primary outcomePrimary: Time to Death — 193; 146 Days
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Death |
193; 146 | — |
| SECONDARY Progression-free Survival |
87; 110 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00745875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.