A Phase 2 interventional study of Cediranib and Cediranib 30 - 90 mg in Cancer, sponsored by AstraZeneca. Completed at 4 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-01.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether food has any effect on a single dose of Cediranib (AZD2171, Recentin™)followed by an assessment of the safety and tolerability of fixed daily dosing in comparison to varying dose levels on a patient-by-patient basis.
AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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Exclusion Criteria:
Part A: Cediranib 45 mg Fed State
Drug: Cediranib
Part A: Cediranib 45 mg Fasted State
Drug: Cediranib
Part B: Cediranib 45 mg Fixed Dose
Drug: Cediranib
Part B: Cediranib 30 - 90 mg Dose Escalation
Drug: Cediranib 30 - 90 mg
45 mg oral dose
Also known as: RECENTIN™
oral tablet dose escalation
Also known as: RECENTIN™
Part A: Area Under Plasma Concentration-time Curve (AUC)
Area under plasma concentration-time curve from zero to infinity
Time frame: Measurements were collected up to 168 hours (following single dosing).
Part A: Maximum Plasma (Peak) Concentration (Cmax)
Maximum plasma drug concentration
Time frame: Measurements were collected up to 168 hours (following single dosing).
Part A: AUC (0-t)
Area under the curve from time 0 to the last measureable time point
Time frame: Measurements were collected up to 168 hours (following single dosing).
Part A: Time to Peak or Maximum Concentration (Tmax)
Time to reach peak or maximum concentration or maximum response
Time frame: Measurements were collected up to 168 hours (following single dosing).
Part A: Terminal Phase Half-life (t1/2λz)
Terminal phase half-life
Time frame: Measurements were collected up to 168 hours (following single dosing).
Part A: Apparent Total Body Clearance (CL/F)
Apparent total body clearance of drug from plasma
Time frame: Measurements were collected up to 168 hours (following single dosing).
Part B: Best Overall Response Rate (ORR)
Evaluation of target lesions Complete Response(CR)Disappearance of all target lesions Partial Response(PR) At least a 30% decrease in the sum of LD(longest diameter)of target lesions taking as reference the baseline sum LD.Progressive Disease(PD).At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded(either at baseline or at previous assessment since treatment began).Stable Disease(SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Note: Appearance of new lesions only counts towards the overall visit response,not towards the response of target or non-target lesions. Evaluation of non-target lesions Complete Response(CR)Disappearance of all non-target lesions Non-Complete Response(non-CR/Non-Progression\[non-PD\])Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.Progression(PD)Unequivocal progression of existing non-target lesions
Time frame: Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation.
Part B: Progression-free Survival (PFS)
Target lesions: Progressive Disease (PD) At least a 20% increase in the sum of LD (longest diameter)of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began). Non target lesions: Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing non-target lesions.
Time frame: Number of days from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
This was a two part study.Part A had two arms, fed/fasted and fasted/fed. Part B had two arms, a fixed dose arm and a dose escalation arm.Patients(pts)in Part A were allowed to go in to Part B. Pts who chose not to go in to Part B discontinued the study.Additionally new pts were recruited to Part B. In Parts A/B, there was a total of 60 pts.
| Milestone | Cediranib 45 mg Fed | Cediranib 45 mg Fasted | Cediranib 45 mg Fixed Dose | Cediranib 30 to 90 mg Dose Escalation |
|---|---|---|---|---|
| Started | 23 | 22 | 0 | 0 |
| Completed | 18 | 16 | 0 | 0 |
| Not completed | 5 | 6 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 | 0 |
| Withdrew: Condition under investigation worsened | 2 | 2 | 0 | 0 |
| Withdrew: Incorrect enrol/entry crit not fulfilled | 0 | 1 | 0 | 0 |
| Withdrew: Partial bowel obstruction | 1 | 0 | 0 | 0 |
| Withdrew: Reaccumul. of ascites following drainage | 0 | 1 | 0 | 0 |
| Withdrew: Suspicion of second malignancy | 0 | 1 | 0 | 0 |
| Withdrew: Qtc interval outwith elig. criteria | 1 | 0 | 0 | 0 |
| Milestone | Cediranib 45 mg Fed | Cediranib 45 mg Fasted | Cediranib 45 mg Fixed Dose | Cediranib 30 to 90 mg Dose Escalation |
|---|---|---|---|---|
| Started | 0 | 0 | 16 | 31 |
| Completed | 0 | 0 | 5 | 14 |
| Not completed | 0 | 0 | 11 | 17 |
| Withdrew: Death | 0 | 0 | 1 | 2 |
| Withdrew: Adverse event | 0 | 0 | 5 | 5 |
| Withdrew: Withdrawal by subject | 0 | 0 | 3 | 1 |
| Withdrew: Condition under investigation worsened | 0 | 0 | 2 | 8 |
| Withdrew: Development of study specific disc crit. | 0 | 0 | 0 | 1 |
Area under plasma concentration-time curve from zero to infinity
| ng*h/mL | Cediranib 45 mg Fed | Cediranib 45 mg Fasted |
|---|---|---|
| Part A: Area Under Plasma Concentration-time Curve (AUC) | 1920 (778 to 5760) | 2392 (604 to 5730) |
Maximum plasma drug concentration
| ng/mL | Arm 1 - Cediranib 45 mg Fed | Arm 2 - Cediranib 45 mg Fasted |
|---|---|---|
| Part A: Maximum Plasma (Peak) Concentration (Cmax) | 87.02 (27.6 to 265) | 127.9 (35.6 to 334) |
Area under the curve from time 0 to the last measureable time point
| ng*h/mL | Arm 1 - Cediranib 45 mg Fed | Arm 2 - Cediranib 45 mg Fasted |
|---|---|---|
| Part A: AUC (0-t) | 1896 (764 to 5700) | 2348 (599 to 5290) |
Time to reach peak or maximum concentration or maximum response
| hr | Arm 1 - Cediranib 45 mg Fed | Arm 2 - Cediranib 45 mg Fasted |
|---|---|---|
| Part A: Time to Peak or Maximum Concentration (Tmax) | 4.59 (2.0 to 25) | 3.52 (2.0 to 6.1) |
Terminal phase half-life
| hr | Arm 1 - Cediranib 45 mg Fed | Arm 2 - Cediranib 45 mg Fasted |
|---|---|---|
| Part A: Terminal Phase Half-life (t1/2λz) | 23.99 (12.1 to 37.5) | 24.72 (10.2 to 60.2) |
Apparent total body clearance of drug from plasma
| L/h | Arm 1 - Cediranib 45 mg Fed | Arm 2 - Cediranib 45 mg Fasted |
|---|---|---|
| Part A: Apparent Total Body Clearance (CL/F) | 23.44 (7.81 to 57.8) | 18.81 (7.85 to 74.5) |
Evaluation of target lesions Complete Response(CR)Disappearance of all target lesions Partial Response(PR) At least a 30% decrease in the sum of LD(longest diameter)of target lesions taking as reference the baseline sum LD.Progressive Disease(PD).At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded(either at baseline or at previous assessment since treatment began).Stable Disease(SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Note: Appearance of new lesions only counts towards the overall visit response,not towards the response of target or non-target lesions. Evaluation of non-target lesions Complete Response(CR)Disappearance of all non-target lesions Non-Complete Response(non-CR/Non-Progression\[non-PD\])Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.Progression(PD)Unequivocal progression of existing non-target lesions
| Participants | Arm 3 - Cediranib 45 mg Fixed Dose | Arm 4 - Cediranib 30-90 mg Dose Escalation |
|---|---|---|
| Part B: Best Overall Response Rate (ORR) | 1 | 3 |
Target lesions: Progressive Disease (PD) At least a 20% increase in the sum of LD (longest diameter)of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began). Non target lesions: Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing non-target lesions.
| Days | Arm 3 - Cediranib 45 mg Fixed Dose | Arm 4 - Cediranib 30-90 mg Dose Escalation |
|---|---|---|
| Part B: Progression-free Survival (PFS) | 135 (39 to 314) | 139 (0 to 454) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cediranib 45 mg Part A | — | 6/39 (15.4%) | 34/39 (87.2%) |
| Cediranib 45 mg Fixed Dose | — | 9/16 (56.3%) | 16/16 (100%) |
| Cediranib 30 - 90 mg Dose Escalation | — | 20/31 (64.5%) | 31/31 (100%) |
| Event | Cediranib 45 mg Part A | Cediranib 45 mg Fixed Dose | Cediranib 30 - 90 mg Dose Escalation |
|---|---|---|---|
| Abdominal PainGastrointestinal disorders | 0/39 | 2/16 | 3/31 |
| DiarrhoeaGastrointestinal disorders | 0/39 | 1/16 | 3/31 |
| VomitingGastrointestinal disorders | 0/39 | 0/16 | 3/31 |
| Angina PectorisCardiac disorders | 1/39 | 1/16 | 0/31 |
| Cardiac FailureCardiac disorders | 0/39 | 1/16 | 0/31 |
| Gastric PerforationGastrointestinal disorders | 0/39 | 1/16 | 0/31 |
| Gastrointestinal HaemorrhageGastrointestinal disorders | 0/39 | 1/16 | 0/31 |
| Intestinal PerforationGastrointestinal disorders | 0/39 | 1/16 | 0/31 |
| PyrexiaGeneral disorders | 0/39 | 1/16 | 1/31 |
| Jaundice CholestaticHepatobiliary disorders | 0/39 | 1/16 | 0/31 |
| Event | Cediranib 45 mg Part A | Cediranib 45 mg Fixed Dose | Cediranib 30 - 90 mg Dose Escalation |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 5/39 | 13/16 | 25/31 |
| HypertensionVascular disorders | 9/39 | 10/16 | 23/31 |
| NauseaGastrointestinal disorders | 9/39 | 11/16 | 17/31 |
| VomitingGastrointestinal disorders | 4/39 | 10/16 | 14/31 |
| ConstipationGastrointestinal disorders | 4/39 | 10/16 | 10/31 |
| FatigueGeneral disorders | 8/39 | 5/16 | 10/31 |
| HeadacheNervous system disorders | 2/39 | 5/16 | 5/31 |
| Abdominal PainGastrointestinal disorders | 1/39 | 4/16 | 9/31 |
| StomatitisGastrointestinal disorders | 0/39 | 4/16 | 9/31 |
| Weight DecreasedInvestigations | 1/39 | 2/16 | 8/31 |
| Age Continuous(Years) | Cediranib 45 mg Fed | Cediranib 45 mg Fasted | Cediranib 45 mg Fixed Dose | Cediranib 30 to 90 mg Dose Escalation | Total |
|---|---|---|---|---|---|
| Mean | 58.6 ± 10.6 | 51.2 ± 14.8 | 56.4 ± 13.1 | 56.0 ± 13.5 | 56.0 ± 13.0 |
| Sex/Gender, Customized(participants) | Cediranib 45 mg Fed | Cediranib 45 mg Fasted | Cediranib 45 mg Fixed Dose | Cediranib 30 to 90 mg Dose Escalation | Total |
|---|---|---|---|---|---|
| Female, Part A | 10 | 10 | NA | NA | 20 |
| Male, Part A | 13 | 12 | NA | NA | 25 |
| Female, Part B | NA | NA | 8 | 12 | 20 |
| Male, Part B | NA | NA | 8 | 19 | 27 |
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