Trial Outcomes & Findings for Ipilimumab in Treating Patients With Metastatic or Recurrent Human Papilloma Virus-Related Cervical Cancer (NCT NCT01693783)
NCT ID: NCT01693783
Last Updated: 2022-11-08
Results Overview
Cumulative count of adverse events meeting the criteria of: frequently occurring, serious and severe events of interest.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2022-11-08
Participant Flow
Participant milestones
| Measure |
Treatment (Ipilimumab)
Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment (Ipilimumab)
n=42 Participants
Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=42 Participants
|
|
Age, Continuous
|
49 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearCumulative count of adverse events meeting the criteria of: frequently occurring, serious and severe events of interest.
Outcome measures
| Measure |
Treatment (Ipilimumab)
n=42 Participants
Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Number of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
|
56 Adverse Events
|
PRIMARY outcome
Timeframe: Up to 1 yearPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Ipilimumab)
n=42 Participants
Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Objective Response Rate Using Response Evaluation Criteria in Solid Tumors
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 1 yearImmune-Related Complete Response (irCR): complete disappearance of all lesions for at least 4 weeks from the date of documentation of complete response. Immune-Related Partial Response (irPR): The sum of the products of the two largest perpendicular diameters of all index lesions is measured and captured as the SPD baseline. At each subsequent tumor assessment, the sum of the products of the two largest perpendicular diameters of all index lesions and of new measurable lesions are added together to provide the Immune Response Sum of Product Diameters (irSPD). A decrease, relative to baseline of the irSPD compared to the previous SPD baseline, of 50% or greater is considered an immune Partial Response (irPR). irStable Disease (irSD): does not meet criteria for irCR or irPR, in the absence of progressive disease.
Outcome measures
| Measure |
Treatment (Ipilimumab)
n=42 Participants
Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Antitumor Activity (Partial Response, Complete Response, and Stable Disease) Using Immune-related Response Criteria (irRC)
|
10 participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Not collected
Number of Participants with Cervical Cancer-antigen Specific T Cells Anti-tumor Response
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearAs per RECIST v1.1, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Treatment (Ipilimumab)
n=42 Participants
Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Disease Stabilization
|
9 participants
|
SECONDARY outcome
Timeframe: Baseline to 1 year after treatmentEvaluation of archival tissue with regard to markers of immune population in correlation with clinical stage and response to treatment
Outcome measures
| Measure |
Treatment (Ipilimumab)
n=42 Participants
Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Markers of Immune Population, Evaluated in Archival Tissue
PD-L1 expression negative at baseline
|
20 participants
|
|
Markers of Immune Population, Evaluated in Archival Tissue
PD-L1 expression is 1% to 10% at baseline
|
4 participants
|
|
Markers of Immune Population, Evaluated in Archival Tissue
PD-L1 expression is more than 10% at baseline
|
4 participants
|
|
Markers of Immune Population, Evaluated in Archival Tissue
PD-L1 expression not available at baseline
|
14 participants
|
|
Markers of Immune Population, Evaluated in Archival Tissue
PD-L1 expression from negative at baseline to positive after treatment
|
5 participants
|
|
Markers of Immune Population, Evaluated in Archival Tissue
IDO expression negatve at baseline
|
23 participants
|
|
Markers of Immune Population, Evaluated in Archival Tissue
IDO expression positive at baseline
|
6 participants
|
|
Markers of Immune Population, Evaluated in Archival Tissue
IDO expression missing at baseline
|
13 participants
|
SECONDARY outcome
Timeframe: Up to week 3 of course 4Population: Not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 1 yearProgressive disease (PD), as per RECIST v1.1, is defined as at least a 20% increase in the sum of the diameters of target lesions and an absolute increase of at least 5mm, or the appearance of one or more new lesions. Computed using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Ipilimumab)
n=42 Participants
Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Progression Free Survival
|
2.5 months
Interval 2.0 to 3.2
|
Adverse Events
Treatment (Ipilimumab)
Serious events: 25 serious events
Other events: 42 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment (Ipilimumab)
n=42 participants at risk
Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
4.8%
2/42 • Number of events 2 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Ascites
|
2.4%
1/42 • Number of events 2 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Colitis
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Colonic fistula
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Colonic obstruction
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Constipation
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
3/42 • Number of events 3 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Enterocolitis
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Nausea
|
4.8%
2/42 • Number of events 2 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Retroperitoneal hemorrhage
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
3/42 • Number of events 3 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
General disorders
Fatigue
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
General disorders
Fever
|
4.8%
2/42 • Number of events 2 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Renal and urinary disorders
Hydronephrosis
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Infections and infestations
Bladder Infection
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Infections and infestations
Lung Infection
|
7.1%
3/42 • Number of events 3 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Infections and infestations
Pelvic infection
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Infections and infestations
Sepsis
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Investigations
Creatinine increased
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
3/42 • Number of events 3 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.8%
2/42 • Number of events 2 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.5%
4/42 • Number of events 4 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Nervous system disorders
Syncope
|
4.8%
2/42 • Number of events 2 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Renal and urinary disorders
Pyelonephritis
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Renal and urinary disorders
Acute Kidney injury
|
4.8%
2/42 • Number of events 2 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Renal and urinary disorders
Urinary tract obstruction
|
4.8%
2/42 • Number of events 2 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
2/42 • Number of events 2 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Vascular disorders
Thromboembolic event
|
2.4%
1/42 • Number of events 1 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
Other adverse events
| Measure |
Treatment (Ipilimumab)
n=42 participants at risk
Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
85.7%
36/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
General disorders
Fatigue
|
85.7%
36/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Investigations
Lymphocyte Count Decreased
|
50.0%
21/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
47.6%
20/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Abdominal Pain
|
54.8%
23/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Investigations
HYPOALBUMINEMIA
|
54.8%
23/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Metabolism and nutrition disorders
Anorexia
|
52.4%
22/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Nausea
|
50.0%
21/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Constipation
|
50.0%
21/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Vascular disorders
Hypertension
|
35.7%
15/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
45.2%
19/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Psychiatric disorders
Anxiety
|
33.3%
14/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
38.1%
16/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
26.2%
11/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
14/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
General disorders
Edema Limbs
|
35.7%
15/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Investigations
Alanine Aminotransferase Increased
|
33.3%
14/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
23.8%
10/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.5%
17/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Investigations
Aspartate Aminotransferase Increased
|
38.1%
16/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
35.7%
15/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Psychiatric disorders
Insomnia
|
28.6%
12/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Metabolism and nutrition disorders
Hyponatremia
|
40.5%
17/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Diarrhea
|
38.1%
16/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Vomiting
|
26.2%
11/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Ear and labyrinth disorders
Cough
|
21.4%
9/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Dry Mouth
|
19.0%
8/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Investigations
Creatinine Increased
|
28.6%
12/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Vascular disorders
Thromboembolic Event
|
26.2%
11/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Metabolism and nutrition disorders
Hypokalemia
|
31.0%
13/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Psychiatric disorders
Depression
|
21.4%
9/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.4%
9/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.6%
12/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
General disorders
Fever
|
21.4%
9/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Reproductive system and breast disorders
Pelvic Pain
|
16.7%
7/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Cardiac disorders
Sinus Tachycardia
|
14.3%
6/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Vascular disorders
Hot Flashes
|
11.9%
5/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Nervous system disorders
Neuralgia
|
11.9%
5/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
6/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
23.8%
10/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Metabolism and nutrition disorders
Dehydration
|
21.4%
9/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Nervous system disorders
Headache
|
16.7%
7/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
6/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.9%
5/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
General disorders
Pain
|
11.9%
5/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
9.5%
4/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
19.0%
8/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
11.9%
5/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Renal and urinary disorders
Hydronephrosis
|
9.5%
4/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Eye disorders
Blurred Vision
|
7.1%
3/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
11.9%
5/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Investigations
White Blood Cell Decreased
|
14.3%
6/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
11.9%
5/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Investigations
Weight loss
|
11.9%
5/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Infections and infestations
Urinary Tract Infection
|
11.9%
5/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Flatulence
|
11.9%
5/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.5%
4/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
9.5%
4/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
9.5%
4/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Bloating
|
9.5%
4/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Renal and urinary disorders
Urinary Frequency
|
9.5%
4/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Hemorrhoid
|
7.1%
3/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Renal and urinary disorders
Urinary Incontinence
|
11.9%
5/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.5%
4/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Renal and urinary disorders
Acute Kidney Injury
|
11.9%
5/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Abdominal Distension
|
7.1%
3/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
3/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Investigations
Lipase Increased
|
7.1%
3/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Injury, poisoning and procedural complications
Bruising
|
7.1%
3/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.5%
4/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Vascular disorders
Hematoma
|
9.5%
4/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Ascites
|
7.1%
3/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
General disorders
Localized Edema
|
7.1%
3/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Nervous system disorders
Paresthesia
|
7.1%
3/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Investigations
White Blood Cell Count Increased
|
7.1%
3/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Renal and urinary disorders
Hematuria
|
9.5%
4/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
7.1%
3/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Investigations
Platelet Count Decreased
|
7.1%
3/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
7.1%
3/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.1%
3/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Nervous system disorders
Dizziness
|
7.1%
3/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
|
Vascular disorders
Hypotension
|
7.1%
3/42 • From treatment start and through monthly follow-up for a maximum of 1 year or until progression of disease or death (whichever occurs first).
Adverse events collected as per protocol using CTCAE version 4.0
|
Additional Information
Dr. Amit Oza
University Health Network - Princess Margaret Cancer Centre
Phone: 416-946-4501
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60