Carcinoma, Non-Small-Cell Lung Carcinoma, Head and Neck Neoplasms
Conditions
Keywords
RECENTIN
Brief 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.
Interventions
DRUGAZD2171
oral tablet
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET) | Randomisation until Day 22 | Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-\[F-18\]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value - baseline SUVmax value)/baseline SUVmax value)\*100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Arterial Blood Pressure (MAP) | Randomisation until Day 22 | Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 - MAP value at baseline). |
Countries
Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cediranib 30 mg Cediranib 30mg/Day | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Condition worsened | 7 |
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Cediranib 30 mg |
|---|---|
| Age Continuous | 58.1 Years STANDARD_DEVIATION 12.32 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 19 |
| serious Total, serious adverse events | 3 / 19 |
Outcome results
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)
Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-\[F-18\]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value - baseline SUVmax value)/baseline SUVmax value)\*100
Time frame: Randomisation until Day 22
Population: Of the 19 patients, only 17 patients were evaluable for FDG-PET analysis. To be evaluable for FDG-PET, patients had to have FDG-PET data collected at Day 1 and at least one post-baseline visit.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cediranib 30 mg | 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 |
Secondary
Change From Baseline in Mean Arterial Blood Pressure (MAP)
Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 - MAP value at baseline).
Time frame: Randomisation until Day 22
Population: Of the 19 patients, only 17 patients were evaluable MAP analysis. To be evaluable for MAP analysis, patients had to have MAP data collected at Day 1 and at least one post-baseline visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cediranib 30 mg | Change From Baseline in Mean Arterial Blood Pressure (MAP) | 6.853 mmHg | 95% Confidence Interval 1.01 |