Trial Outcomes & Findings for AZD2171 to Treat Prostate Cancer (NCT NCT00436956)

Last Updated: 2018-10-09

Results Overview

PFS is the proportion of subjects who progress or die by 6 months after the start of the combined therapy. PFS is determined by prostatic specific antigen (PSA) consensus criteria and the Response Evaluation Criteria in Solid Tumors (RECIST). PSA consensus criteria is defined as PSA decline of \>/= 50% or PSA progression. RECIST is defined as the following: Complete response (CR) is disappearance of all target lesions; partial response (PR) is at least a 30% decline in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease ((PD) at least a 20% increase in the sum of the LD of target lesions, or the appearance of one or more lesions), taking as reference the smallest sum LD since the treatment started. Data is estimated and the probability of PFS as a function of time was determined using the Kaplan-Meier method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

59 participants

Primary outcome timeframe

6 months

Results posted on

2018-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	20 mg AZD2171 Daily Participants received 20 mg AZD2171 (Cediranib) orally daily.	20 mg AZD2171 + 10mg Prednisone Daily Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
Overall Study STARTED	36	23
Overall Study COMPLETED	35	23
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	20 mg AZD2171 Daily Participants received 20 mg AZD2171 (Cediranib) orally daily.	20 mg AZD2171 + 10mg Prednisone Daily Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
Overall Study Not evaluable	1	0

Baseline Characteristics

AZD2171 to Treat Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants - AZD2171 & Prednisone n=59 Participants This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	39 Participants n=5 Participants
Age, Continuous	68.9 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants
Race/Ethnicity, Customized Afican-American	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized White	52 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants
Region of Enrollment United States	59 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: One participant was not evaluable owing to the development of a cord compression on day 2 of therapy and was subsequently removed from the trial. Since the prednisone was added to relieve toxicity \& outcome data is based on response, the cohorts were analyzed together in terms of response. No suggestion prednisone significantly altered outcomes.

Outcome measures

Outcome measures
Measure	All Participants - AZD2171 & Prednisone n=58 Participants This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).	20 mg AZD2171 + 10mg Prednisone Daily Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
Percent Probability of Participants With 6-month Progression-free Survival (PFS)	43.9 percent probability	—

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 61.5 months

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.

Outcome measures

Outcome measures
Measure	All Participants - AZD2171 & Prednisone n=59 Participants This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).	20 mg AZD2171 + 10mg Prednisone Daily Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
Number of Participants With Adverse Events	59 Participants	—

SECONDARY outcome

Timeframe: 61.5 months

Population: Only 58 participants were evaluable for toxicity.

Here is the number of Grade 2 (moderate) toxicities.

Outcome measures

Outcome measures
Measure	All Participants - AZD2171 & Prednisone n=35 Participants This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).	20 mg AZD2171 + 10mg Prednisone Daily n=23 Participants Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
Number of Grade 2 Toxicities Hypertension	17 toxicities	8 toxicities
Number of Grade 2 Toxicities Fatigue	15 toxicities	4 toxicities
Number of Grade 2 Toxicities Anorexia	12 toxicities	6 toxicities
Number of Grade 2 Toxicities Weight loss	11 toxicities	4 toxicities
Number of Grade 2 Toxicities Hypothyroidism	7 toxicities	6 toxicities
Number of Grade 2 Toxicities Dehydration	8 toxicities	2 toxicities
Number of Grade 2 Toxicities Prolonged QTc	8 toxicities	2 toxicities
Number of Grade 2 Toxicities Nausea	7 toxicities	3 toxicities
Number of Grade 2 Toxicities Diarrhea	8 toxicities	0 toxicities
Number of Grade 2 Toxicities Hypoalbuminemia	5 toxicities	3 toxicities
Number of Grade 2 Toxicities Proteinuria	5 toxicities	3 toxicities
Number of Grade 2 Toxicities Elevated alkaline phosphatase	4 toxicities	2 toxicities
Number of Grade 2 Toxicities Aspartate transaminase	3 toxicities	3 toxicities
Number of Grade 2 Toxicities Vomiting	4 toxicities	2 toxicities
Number of Grade 2 Toxicities Hyperbilirubinemia	4 toxicities	1 toxicities
Number of Grade 2 Toxicities Muscle weakness	2 toxicities	1 toxicities

SECONDARY outcome

Timeframe: 61.5 months

Population: Only 58 participants were evaluable for toxicity.

Here is the number of Grade 3 (severe) toxicities.

Outcome measures

Outcome measures
Measure	All Participants - AZD2171 & Prednisone n=35 Participants This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).	20 mg AZD2171 + 10mg Prednisone Daily n=23 Participants Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
Number of Grade 3 Toxicities Hypertension	0 toxicities	0 toxicities
Number of Grade 3 Toxicities Fatigue	4 toxicities	2 toxicities
Number of Grade 3 Toxicities Anorexia	1 toxicities	1 toxicities
Number of Grade 3 Toxicities Weight loss	2 toxicities	0 toxicities
Number of Grade 3 Toxicities Hypothyroidism	0 toxicities	0 toxicities
Number of Grade 3 Toxicities Dehydration	3 toxicities	3 toxicities
Number of Grade 3 Toxicities Prolonged QTc	1 toxicities	1 toxicities
Number of Grade 3 Toxicities Nausea	1 toxicities	0 toxicities
Number of Grade 3 Toxicities Diarrhea	0 toxicities	0 toxicities
Number of Grade 3 Toxicities Hypoalbuminemia	0 toxicities	0 toxicities
Number of Grade 3 Toxicities Proteinuria	0 toxicities	0 toxicities
Number of Grade 3 Toxicities Elevated alkaline phosphatase	5 toxicities	0 toxicities
Number of Grade 3 Toxicities Aspartate transaminase	2 toxicities	0 toxicities
Number of Grade 3 Toxicities Vomiting	1 toxicities	0 toxicities
Number of Grade 3 Toxicities Hyperbilirubinemia	1 toxicities	0 toxicities
Number of Grade 3 Toxicities Muscle weakness	3 toxicities	1 toxicities

SECONDARY outcome

Timeframe: 44 months

Time from treatment start date until date of death or date last known alive.

Outcome measures

Outcome measures
Measure	All Participants - AZD2171 & Prednisone n=35 Participants This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).	20 mg AZD2171 + 10mg Prednisone Daily n=23 Participants Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
Median Overall Survival	11.7 Months Interval 6.8 to 15.0	9.9 Months Interval 5.7 to 14.8

SECONDARY outcome

Timeframe: up to 14.9 months based on a Kaplan-Meier analysis.

Time interval from start of treatment to documented evidence of disease progression.

Outcome measures

Outcome measures
Measure	All Participants - AZD2171 & Prednisone n=35 Participants This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).	20 mg AZD2171 + 10mg Prednisone Daily n=23 Participants Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
Median Progression Free Survival (PFS)	3.6 Months Interval 2.0 to 14.9	3.7 Months Interval 2.0 to 14.9

SECONDARY outcome

Timeframe: Every 2 cycles (approximately 56 days)

Population: One patient was not evaluable owing to the development of a cord compression on day 2 of therapy and was subsequently removed from the trial. Out of 59 patients, 39 had measurable disease.

Response was evaluated by the RECIST. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD)is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Outcome measures

Outcome measures
Measure	All Participants - AZD2171 & Prednisone n=39 Participants This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).	20 mg AZD2171 + 10mg Prednisone Daily Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Complete Response	0 Participants	—
Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Confirmed Partial Response	6 Participants	—
Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Unconfirmed Partial Response	1 Participants	—
Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Not Evaluable	1 Participants	—

Adverse Events

All Participants - AZD2171 & Prednisone

Serious events: 59 serious events

Other events: 56 other events

Deaths: 40 deaths

Serious adverse events

Serious adverse events
Measure	All Participants - AZD2171 & Prednisone n=59 participants at risk This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
Gastrointestinal disorders Abdominal pain	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders Activated partial thromboplastin time prolonged	6.8% 4/59 • Number of events 6 • Date treatment consent signed to date off study, approximately 61.5 months.
Renal and urinary disorders Acute kidney injury	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Alanine aminotransferase increased	8.5% 5/59 • Number of events 6 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Alkaline phosphatase increased	35.6% 21/59 • Number of events 28 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders Anemia	25.4% 15/59 • Number of events 30 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Anorexia	35.6% 21/59 • Number of events 22 • Date treatment consent signed to date off study, approximately 61.5 months.
Musculoskeletal and connective tissue disorders Arthralgia	11.9% 7/59 • Number of events 8 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Aspartate aminotransferase increased	20.3% 12/59 • Number of events 17 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Ataxia	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Musculoskeletal and connective tissue disorders Back pain	6.8% 4/59 • Number of events 4 • Date treatment consent signed to date off study, approximately 61.5 months.
Renal and urinary disorders Bladder spasm	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Blood bilirubin increased	10.2% 6/59 • Number of events 6 • Date treatment consent signed to date off study, approximately 61.5 months.
Eye disorders Blurred vision	3.4% 2/59 • Number of events 3 • Date treatment consent signed to date off study, approximately 61.5 months.
Musculoskeletal and connective tissue disorders Bone pain	20.3% 12/59 • Number of events 13 • Date treatment consent signed to date off study, approximately 61.5 months.
Musculoskeletal and connective tissue disorders Buttock pain	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders CPK increased	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Cardiac disorders Cardiac disorders - Other, specify (Prolonged QTc)	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Chest wall pain	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Confusion	6.8% 4/59 • Number of events 4 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Constipation	5.1% 3/59 • Number of events 3 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Creatinine increased	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
General disorders Death NOS	67.8% 40/59 • Number of events 40 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Dehydration	30.5% 18/59 • Number of events 27 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Depression	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Diarrhea	16.9% 10/59 • Number of events 11 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders Disseminated intravascular coagulation	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Dizziness	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Dysgeusia	5.1% 3/59 • Number of events 3 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Dysphasia	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.1% 3/59 • Number of events 4 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders Edema limbs	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Cardiac disorders Electrocardiogram QT corrected interval prolonged	20.3% 12/59 • Number of events 15 • Date treatment consent signed to date off study, approximately 61.5 months.
Eye disorders Eye disorders - Other, specify (CRAO)	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Eye disorders Eyelid function disorder	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Facial nerve disorder	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
General disorders Fatigue	45.8% 27/59 • Number of events 37 • Date treatment consent signed to date off study, approximately 61.5 months.
General disorders Fever	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Musculoskeletal and connective tissue disorders Fracture	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	8.5% 5/59 • Number of events 7 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Gum infection	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Headache	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Ear and labyrinth disorders Hearing impaired	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Renal and urinary disorders Hematuria	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hyperglycemia	6.8% 4/59 • Number of events 4 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hyperkalemia	8.5% 5/59 • Number of events 5 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hypermagnesemia	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Vascular disorders Hypertension	44.1% 26/59 • Number of events 26 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hyperuricemia	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hypoalbuminemia	23.7% 14/59 • Number of events 18 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hypocalcemia	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hypoglycemia	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hypokalemia	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hyponatremia	10.2% 6/59 • Number of events 7 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hypophosphatemia	11.9% 7/59 • Number of events 7 • Date treatment consent signed to date off study, approximately 61.5 months.
Vascular disorders Hypotension	10.2% 6/59 • Number of events 9 • Date treatment consent signed to date off study, approximately 61.5 months.
Endocrine disorders Hypothyroidism	22.0% 13/59 • Number of events 13 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders INR increased	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Infections and infestations Infections and infestations - Other, specify (Infection)	1.7% 1/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders Intracranial hemorrhage	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Investigations Investigations - Other, specify (CPK)	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Infections and infestations Joint infection	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Lung infection	3.4% 2/59 • Number of events 3 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders Lymph gland infection	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders Lymphocyte count decreased	25.4% 15/59 • Number of events 25 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Memory impairment	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Mucositis oral	1.7% 1/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	6.8% 4/59 • Number of events 4 • Date treatment consent signed to date off study, approximately 61.5 months.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Infections and infestations Myositis	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Nausea	23.7% 14/59 • Number of events 16 • Date treatment consent signed to date off study, approximately 61.5 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	8.5% 5/59 • Number of events 5 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders Neutrophil count decreased	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Eye disorders Optic nerve disorder	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Oral pain	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
General disorders Pain	6.8% 4/59 • Number of events 4 • Date treatment consent signed to date off study, approximately 61.5 months.
Musculoskeletal and connective tissue disorders Pain in extremity	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Cardiac disorders Pericardial effusion	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Peripheral sensory neuropathy	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	1.7% 1/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders Platelet count decreased	10.2% 6/59 • Number of events 9 • Date treatment consent signed to date off study, approximately 61.5 months.
Cardiac disorders Pleural effusion	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Proteinuria	13.6% 8/59 • Number of events 14 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Psychosis	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Immune system disorders Rhinitis infective	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Sinus disorder	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Sinusitis	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Skin and subcutaneous tissue disorders Skin infection	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Skin and subcutaneous tissue disorders Skin ulceration	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Vascular disorders Thromboembolic event	5.1% 3/59 • Number of events 3 • Date treatment consent signed to date off study, approximately 61.5 months.
Ear and labyrinth disorders Tinnitus	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Renal and urinary disorders Urinary retention	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Renal and urinary disorders Urinary tract infection	10.2% 6/59 • Number of events 6 • Date treatment consent signed to date off study, approximately 61.5 months.
Renal and urinary disorders Urinary tract obstruction	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Renal and urinary disorders Urinary tract pain	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Vascular disorders Venous injury	1.7% 1/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Voice alteration	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Vomiting	13.6% 8/59 • Number of events 11 • Date treatment consent signed to date off study, approximately 61.5 months.
General disorders Weight loss	32.2% 19/59 • Number of events 24 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders White blood cell decreased	6.8% 4/59 • Number of events 4 • Date treatment consent signed to date off study, approximately 61.5 months.

Other adverse events

Other adverse events
Measure	All Participants - AZD2171 & Prednisone n=59 participants at risk This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
Gastrointestinal disorders Abdominal pain	5.1% 3/59 • Number of events 3 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Agitation	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Alanine aminotransferase increased	20.3% 12/59 • Number of events 15 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Alkaline phosphatase increased	10.2% 6/59 • Number of events 6 • Date treatment consent signed to date off study, approximately 61.5 months.
Immune system disorders Allergic rhinitis	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders Anemia	11.9% 7/59 • Number of events 11 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Anorexia	25.4% 15/59 • Number of events 15 • Date treatment consent signed to date off study, approximately 61.5 months.
Musculoskeletal and connective tissue disorders Arthralgia	13.6% 8/59 • Number of events 8 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Aspartate aminotransferase increased	25.4% 15/59 • Number of events 17 • Date treatment consent signed to date off study, approximately 61.5 months.
Cardiac disorders Atrioventricular block first degree	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Musculoskeletal and connective tissue disorders Back pain	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify (Cervical lymh node)	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Blood bilirubin increased	6.8% 4/59 • Number of events 4 • Date treatment consent signed to date off study, approximately 61.5 months.
Eye disorders Blurred vision	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Musculoskeletal and connective tissue disorders Bone pain	10.2% 6/59 • Number of events 6 • Date treatment consent signed to date off study, approximately 61.5 months.
Reproductive system and breast disorders Breast pain	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Skin and subcutaneous tissue disorders Bruising	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Cardiac disorders Cardiac disorders - Other, specify (Inverted T waves)	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Chest wall pain	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
General disorders Chills	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Confusion	5.1% 3/59 • Number of events 3 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Constipation	8.5% 5/59 • Number of events 5 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Cough	6.8% 4/59 • Number of events 4 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Creatinine increased	8.5% 5/59 • Number of events 6 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Dehydration	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Depression	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Diarrhea	59.3% 35/59 • Number of events 42 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Dizziness	20.3% 12/59 • Number of events 13 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Dry mouth	8.5% 5/59 • Number of events 5 • Date treatment consent signed to date off study, approximately 61.5 months.
Skin and subcutaneous tissue disorders Dry skin	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Dysgeusia	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Dyspepsia	5.1% 3/59 • Number of events 3 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.8% 4/59 • Number of events 4 • Date treatment consent signed to date off study, approximately 61.5 months.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify (Ear fullness)	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders Edema face	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders Edema limbs	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Cardiac disorders Electrocardiogram QT corrected interval prolonged	13.6% 8/59 • Number of events 8 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Extrapyramidal disorder	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Eye disorders Eye disorders - Other, specify (Opthalmoplegia/diplopia (double Vision))	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
General disorders Fatigue	37.3% 22/59 • Number of events 25 • Date treatment consent signed to date off study, approximately 61.5 months.
General disorders Fever	3.4% 2/59 • Number of events 3 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Flatulence	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Skin and subcutaneous tissue disorders Flushing	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Forced expiratory volume decreased	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Glossopharyngeal nerve disorder	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Headache	20.3% 12/59 • Number of events 13 • Date treatment consent signed to date off study, approximately 61.5 months.
Renal and urinary disorders Hematuria	6.8% 4/59 • Number of events 4 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hemoglobinuria	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Endocrine disorders Hot flashes	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
General disorders Hyperhidrosis	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hyperkalemia	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hypermagnesemia	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Vascular disorders Hypertension	10.2% 6/59 • Number of events 6 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hyperuricemia	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hypoalbuminemia	5.1% 3/59 • Number of events 4 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hypocalcemia	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hypokalemia	6.8% 4/59 • Number of events 4 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hypomagnesemia	11.9% 7/59 • Number of events 7 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Hyponatremia	5.1% 3/59 • Number of events 3 • Date treatment consent signed to date off study, approximately 61.5 months.
Vascular disorders Hypotension	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Endocrine disorders Hypothyroidism	27.1% 16/59 • Number of events 19 • Date treatment consent signed to date off study, approximately 61.5 months.
Infections and infestations Infections and infestations - Other, specify (Upper resp)	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
General disorders Insomnia	5.1% 3/59 • Number of events 3 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders Lymphocyte count decreased	5.1% 3/59 • Number of events 3 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Mucositis oral	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Musculoskeletal and connective tissue disorders Myalgia	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Skin and subcutaneous tissue disorders Nail loss	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Nausea	23.7% 14/59 • Number of events 15 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Nervous system disorders - Other, specify (Staring spells)	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders Oral hemorrhage	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Oral pain	5.1% 3/59 • Number of events 3 • Date treatment consent signed to date off study, approximately 61.5 months.
General disorders Pain	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Cardiac disorders Paroxysmal atrial tachycardia	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Nervous system disorders Peripheral sensory neuropathy	5.1% 3/59 • Number of events 3 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders Platelet count decreased	11.9% 7/59 • Number of events 8 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.1% 3/59 • Number of events 4 • Date treatment consent signed to date off study, approximately 61.5 months.
Metabolism and nutrition disorders Proteinuria	22.0% 13/59 • Number of events 16 • Date treatment consent signed to date off study, approximately 61.5 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders Rectal hemorrhage	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify (Rhinorrhea)	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Sinus disorder	3.4% 2/59 • Number of events 3 • Date treatment consent signed to date off study, approximately 61.5 months.
Renal and urinary disorders Urinary frequency	10.2% 6/59 • Number of events 6 • Date treatment consent signed to date off study, approximately 61.5 months.
Renal and urinary disorders Urinary incontinence	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.
Renal and urinary disorders Urinary tract obstruction	3.4% 2/59 • Number of events 2 • Date treatment consent signed to date off study, approximately 61.5 months.
Respiratory, thoracic and mediastinal disorders Voice alteration	25.4% 15/59 • Number of events 16 • Date treatment consent signed to date off study, approximately 61.5 months.
Gastrointestinal disorders Vomiting	18.6% 11/59 • Number of events 11 • Date treatment consent signed to date off study, approximately 61.5 months.
General disorders Weight loss	35.6% 21/59 • Number of events 22 • Date treatment consent signed to date off study, approximately 61.5 months.
Blood and lymphatic system disorders White blood cell decreased	1.7% 1/59 • Number of events 1 • Date treatment consent signed to date off study, approximately 61.5 months.

Additional Information

William L. Dahut, M.D.

National Cancer Institute

Phone: 301-435-8183

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place