Phase 1 Completed N=19 Treatment

The Effects of AZD2171 in Patients With Non-Small Cell Lung Cancer or Head & Neck Cancer

Carcinoma · Non-Small Cell Lung Carcinoma · Head and Neck Cancer

Source: ClinicalTrials.gov NCT00243347 ↗

Enrolled (actual)

Serious AEs

15.8%

Results posted

Oct 2013

Primary outcomePrimary: Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET) — -18.386 Percentage change in SUVmax

Summary

This study is to examine the effects on tumors of AZD2171, in the treatment of NSCLC or HNC. The safety and tolerability of AZD2171 will also be studied.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET)	-18.386	—
SECONDARY Change From Baseline in Mean Arterial Blood Pressure (MAP)	6.853	—

Eligibility Criteria

Inclusion Criteria

Histologically or cytologically confirmed head and neck cancer (HNC) or unresectable stage IIIb or IV non-small cell lung cancer (NSCLC)
At least one lesion able to be used for tumor biopsy and to be measured by FDG-PET Scan
Considered suitable for treatment of NSCLC with no prior biological or immunological therapy for disease
Or considered suitable for treatment for metastatic or recurrent HNC with no prior biological or immunological therapy for disease

Exclusion Criteria

NSCLC: Have received more than 2 previous chemotherapy regimens or have received the last chemotherapy or radiotherapy within 28 days of first dose of AZD2171
HNC: Previous chemotherapy or radiotherapy if received 28 days of first dose of AZD2171
Untreatable, unstable brain or meningeal metastases.
Abnormal liver and kidney blood chemistries
History of poorly controlled hypertension with resting blood pressure of >150/100
Recent (< 14 days) major surgery or a surgical incision not fully healed
Diabetes patients with type I insulin dependent diabetes or poorly controlled type II
Significant hemorrhage or hemoptysis
Presence of necrotic/hemorrhagic tumor or metastases

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00243347). 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.