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Olaparib in People With Malignant Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531840
Recruitment Status : Completed
First Posted : May 22, 2018
Results First Posted : March 11, 2021
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Raffit Hassan, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mesothelioma
Interventions Drug: Olaparib
Device: ClinOmics
Enrollment 23
Recruitment Details  
Pre-assignment Details Data is grouped as specified per protocol.
Arm/Group Title Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations Participants Not Classified Under Comparison Groups
Hide Arm/Group Description Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations Participants With no tumor tissue available for somatic mutation
Period Title: Overall Study
Started 5 6 8 4
Completed 0 1 3 1
Not Completed 5 5 5 3
Reason Not Completed
Death on study             3             2             1             2
Death during follow up             2             3             4             1
Arm/Group Title Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations Participants Not Classified Under Comparison Groups Total
Hide Arm/Group Description Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations Participants With no tumor tissue available for somatic mutation Participants With no tumor tissue available for somatic mutation Total of all reporting groups
Overall Number of Baseline Participants 5 6 8 4 23
Hide Baseline Analysis Population Description
Data is grouped as specified per protocol.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 8 participants 4 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  80.0%
4
  66.7%
4
  50.0%
1
  25.0%
13
  56.5%
>=65 years
1
  20.0%
2
  33.3%
4
  50.0%
3
  75.0%
10
  43.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 6 participants 8 participants 4 participants 23 participants
56.6  (14.51) 61.82  (10.71) 63.3  (10.5) 65.3  (4.19) 61.8  (10.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 8 participants 4 participants 23 participants
Female
3
  60.0%
3
  50.0%
3
  37.5%
0
   0.0%
9
  39.1%
Male
2
  40.0%
3
  50.0%
5
  62.5%
4
 100.0%
14
  60.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 8 participants 4 participants 23 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
5
 100.0%
6
 100.0%
7
  87.5%
4
 100.0%
22
  95.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
1
   4.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 8 participants 4 participants 23 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
5
 100.0%
6
 100.0%
8
 100.0%
4
 100.0%
23
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 8 participants 4 participants 23 participants
United States 5 6 7 3 21
Canada 0 0 1 1 2
1.Primary Outcome
Title Number of Participants With an Objective Response
Hide Description Number of participants overall who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.
Time Frame 6 months after enrollment of last patient
Hide Outcome Measure Data
Hide Analysis Population Description
Data is grouped as specified per protocol.
Arm/Group Title Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations Participants Not Classified Under Comparison Groups
Hide Arm/Group Description:
Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes
Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations
Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations
Participants with no tumor tissue available for somatic mutation
Overall Number of Participants Analyzed 5 6 8 4
Measure Type: Count of Participants
Unit of Measure: Participants
Partial Response
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
Complete Response
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Germline Deoxyribonucleic Acid (DNA) Repair Mutation Who Experienced Partial or Complete Response.
Hide Description Number of participants with germline deoxyribonucleic acid (DNA) repair mutation who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.
Time Frame 6 months after enrollment of last patient
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, this outcome measure was only assessed in participants in Comparison Group 1.
Arm/Group Title Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes
Hide Arm/Group Description:
Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes
Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
Partial Response
1
  20.0%
Complete Response
0
   0.0%
3.Primary Outcome
Title Percentage of Participants With Breast Cancer Type 1 Associated Protein-1 (BAP1) Somatic Mutations Who Experienced Partial or Complete Response.
Hide Description Percentage of participants with germline deoxyribonucleic acid (DNA) repair mutation who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.
Time Frame 6 months after enrollment of last patient
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, this outcome measure was only assessed in participants in Comparison Group 2.
Arm/Group Title Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations
Hide Arm/Group Description:
Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: percentage of participants
Partial Response 0
Complete Response 0
4.Primary Outcome
Title Percentage of Subjects With Neither Germline Deoxyribonuclecic Acid (DNA) Repair Mutations Nor Somatic Breast Cancer Type 1 Associated Protein-1 (BAP1) Mutations Who Experienced Partial or Complete Response.
Hide Description Percentage of subjects with neither germline DNA repair mutations nor somatic BAP1 mutations who experienced partial or complete response.Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.
Time Frame 6 months after enrollment of last patient
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, this outcome measure was only assessed in participants in Comparison Group 3.
Arm/Group Title Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations
Hide Arm/Group Description:
Participants With no tumor tissue available for somatic mutation
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percentage of participants
Partial Response 0
Complete Response 0
5.Primary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Adverse events were recorded from the study start date until prior to the study completion date, approximately 27 months and 11 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Data is grouped as specified per protocol.
Arm/Group Title Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations Participants Not Classified Under Comparison Groups
Hide Arm/Group Description:
Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes
Comparison Group 2 Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations
Participants With no tumor tissue available for somatic mutation
Participants With no tumor tissue available for somatic mutation
Overall Number of Participants Analyzed 5 6 8 4
Measure Type: Count of Participants
Unit of Measure: Participants
5
 100.0%
6
 100.0%
8
 100.0%
4
 100.0%
6.Secondary Outcome
Title Number of Participants With Dose Limiting-toxicities (DLT's)
Hide Description Dose Limiting-toxicities (DLT's) is defined as
Time Frame 21 days after enrollment of last subject
Hide Outcome Measure Data
Hide Analysis Population Description
Data is grouped as specified per protocol.
Arm/Group Title Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations Participants Not Classified Under Comparison Groups
Hide Arm/Group Description:
Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes
Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations
Participants With no tumor tissue available for somatic mutation
Participants With no tumor tissue available for somatic mutation
Overall Number of Participants Analyzed 5 6 8 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame Date treatment consent signed to date off study, approximately 18 months and 25 days for Group 1, 27 months and 8 days for Group 2, and 26 months and 18 days for both Group 3 and Participants not classified under comparison groups..
Adverse Event Reporting Description Data is grouped as specified per protocol.
 
Arm/Group Title Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations Participants Not Classified Under Comparison Groups
Hide Arm/Group Description Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations Participants With no tumor tissue available for somatic mutation Participants With no tumor tissue available for somatic mutation
All-Cause Mortality
Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations Participants Not Classified Under Comparison Groups
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/5 (100.00%)      5/6 (83.33%)      5/8 (62.50%)      3/4 (75.00%)    
Hide Serious Adverse Events
Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations Participants Not Classified Under Comparison Groups
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      4/6 (66.67%)      1/8 (12.50%)      1/4 (25.00%)    
Eye disorders         
Eye disorders - Other, Eye disorders - Lt orbital solitary  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain  1  0/5 (0.00%)  0 2/6 (33.33%)  2 0/8 (0.00%)  0 0/4 (0.00%)  0
General disorders         
Disease progression  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
Pain  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1
Infections and infestations         
Lung infection  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0
Metabolism and nutrition disorders         
Hypercalcemia  1  0/5 (0.00%)  0 1/6 (16.67%)  2 0/8 (0.00%)  0 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Non-cardiac chest pain  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Aspiration  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0
Dyspnea  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1
1
Term from vocabulary, CTCAE (5.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations Participants Not Classified Under Comparison Groups
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/5 (100.00%)      6/6 (100.00%)      8/8 (100.00%)      4/4 (100.00%)    
Blood and lymphatic system disorders         
Anemia  1  5/5 (100.00%)  10 3/6 (50.00%)  7 2/8 (25.00%)  2 2/4 (50.00%)  7
Cardiac disorders         
Sinus tachycardia  1  3/5 (60.00%)  3 1/6 (16.67%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0
Endocrine disorders         
Endocrine disorders - Other, thyrotropin  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
Eye disorders         
Blurred vision  1  1/5 (20.00%)  1 1/6 (16.67%)  2 1/8 (12.50%)  1 0/4 (0.00%)  0
Dry eye  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 1/4 (25.00%)  1
Eye disorders - Other, macular degeneration  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0
Eye pain  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0
Keratitis  1  0/5 (0.00%)  0 1/6 (16.67%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0
Optic nerve disorder  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0
Vision decreased  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0
Eye disorders - Other, eye disorder, diplopia  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0
Eye disorders - Other, eye disorder, Lt potosis  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0
Eye disorders - Other, eye disorder, proptosis  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0
Eye disorders - Other, vision loss  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1
Gastrointestinal disorders         
Abdominal distension  1  0/5 (0.00%)  0 1/6 (16.67%)  1 1/8 (12.50%)  2 0/4 (0.00%)  0
Abdominal pain  1  2/5 (40.00%)  2 0/6 (0.00%)  0 2/8 (25.00%)  4 2/4 (50.00%)  2
Ascites  1  1/5 (20.00%)  1 1/6 (16.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0
Belching  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0
Bloating  1  1/5 (20.00%)  2 0/6 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0
Constipation  1  2/5 (40.00%)  2 1/6 (16.67%)  1 2/8 (25.00%)  4 3/4 (75.00%)  3
Diarrhea  1  3/5 (60.00%)  9 2/6 (33.33%)  3 1/8 (12.50%)  1 1/4 (25.00%)  1
Dyspepsia  1  1/5 (20.00%)  3 1/6 (16.67%)  1 2/8 (25.00%)  2 1/4 (25.00%)  1
Gastroesophageal reflux disease  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1
Nausea  1  3/5 (60.00%)  3 4/6 (66.67%)  5 6/8 (75.00%)  7 3/4 (75.00%)  4
Toothache  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0
Vomiting  1  2/5 (40.00%)  2 3/6 (50.00%)  4 3/8 (37.50%)  7 1/4 (25.00%)  1
General disorders         
Edema limbs  1  0/5 (0.00%)  0 1/6 (16.67%)  2 1/8 (12.50%)  1 0/4 (0.00%)  0
Facial pain  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
Fatigue  1  3/5 (60.00%)  5 5/6 (83.33%)  5 2/8 (25.00%)  3 2/4 (50.00%)  2
Fever  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0
Flu like symptoms  1  1/5 (20.00%)  1 0/6 (0.00%)  0 2/8 (25.00%)  2 0/4 (0.00%)  0
General disorders and administration site conditions - Other, cachexia  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0
Localized edema  1  1/5 (20.00%)  1 1/6 (16.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0
Pain  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  3
Infections and infestations         
Lung infection  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0
Tooth infection  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0
Upper respiratory infection  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1
Urinary tract infection  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  2 0/4 (0.00%)  0
Investigations         
Activated partial thromboplastin time prolonged  1  1/5 (20.00%)  1 2/6 (33.33%)  2 0/8 (0.00%)  0 0/4 (0.00%)  0
Alanine aminotransferase increased  1  0/5 (0.00%)  0 0/6 (0.00%)  0 2/8 (25.00%)  2 0/4 (0.00%)  0
Alkaline phosphatase increased  1  0/5 (0.00%)  0 1/6 (16.67%)  1 1/8 (12.50%)  1 1/4 (25.00%)  2
Aspartate aminotransferase increased  1  1/5 (20.00%)  1 0/6 (0.00%)  0 2/8 (25.00%)  5 0/4 (0.00%)  0
Blood lactate dehydrogenase increased  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  2 0/4 (0.00%)  0
Creatinine increased  1  3/5 (60.00%)  7 2/6 (33.33%)  5 3/8 (37.50%)  6 1/4 (25.00%)  1
Dehydration  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0
GGT increased  1  1/5 (20.00%)  1 0/6 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
Lymphocyte count decreased  1  4/5 (80.00%)  16 5/6 (83.33%)  8 6/8 (75.00%)  17 3/4 (75.00%)  5
Platelet count decreased  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  3 0/4 (0.00%)  0
Weight gain  1  0/5 (0.00%)  0 1/6 (16.67%)  4 0/8 (0.00%)  0 0/4 (0.00%)  0
Weight loss  1  2/5 (40.00%)  3 1/6 (16.67%)  2 2/8 (25.00%)  3 2/4 (50.00%)  3
White blood cell decreased  1  1/5 (20.00%)  1 0/6 (0.00%)  0 2/8 (25.00%)  4 0/4 (0.00%)  0
Metabolism and nutrition disorders         
Anorexia  1  3/5 (60.00%)  4 3/6 (50.00%)  3 4/8 (50.00%)  4 2/4 (50.00%)  2
Hypercalcemia  1  2/5 (40.00%)  3 3/6 (50.00%)  4 2/8 (25.00%)  4 1/4 (25.00%)  2
Hyperglycemia  1  3/5 (60.00%)  5 2/6 (33.33%)  2 3/8 (37.50%)  3 3/4 (75.00%)  4
Hyperkalemia  1  1/5 (20.00%)  1 1/6 (16.67%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0
Hypermagnesemia  1  1/5 (20.00%)  2 1/6 (16.67%)  2 0/8 (0.00%)  0 0/4 (0.00%)  0
Hyperphosphatemia  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0
Hypoalbuminemia  1  4/5 (80.00%)  5 5/6 (83.33%)  9 2/8 (25.00%)  2 2/4 (50.00%)  3
Hypocalcemia  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
Hypoglycemia  1  0/5 (0.00%)  0 0/6 (0.00%)  0 2/8 (25.00%)  2 0/4 (0.00%)  0
Hypokalemia  1  2/5 (40.00%)  2 0/6 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0
Hypomagnesemia  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
Hyponatremia  1  0/5 (0.00%)  0 2/6 (33.33%)  2 1/8 (12.50%)  2 1/4 (25.00%)  3
Hypophosphatemia  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain  1  0/5 (0.00%)  0 1/6 (16.67%)  1 2/8 (25.00%)  2 1/4 (25.00%)  1
Flank pain  1  0/5 (0.00%)  0 1/6 (16.67%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0
Muscle cramp  1  1/5 (20.00%)  1 0/6 (0.00%)  0 1/8 (12.50%)  2 0/4 (0.00%)  0
Myalgia  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 1/4 (25.00%)  1
Non-cardiac chest pain  1  1/5 (20.00%)  1 1/6 (16.67%)  1 0/8 (0.00%)  0 1/4 (25.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, brain metastases  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1
Tumor pain  1  0/5 (0.00%)  0 1/6 (16.67%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0
Nervous system disorders         
Dizziness  1  0/5 (0.00%)  0 0/6 (0.00%)  0 2/8 (25.00%)  2 1/4 (25.00%)  1
Dysgeusia  1  1/5 (20.00%)  1 2/6 (33.33%)  2 2/8 (25.00%)  2 1/4 (25.00%)  1
Dysphasia  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0
Headache  1  1/5 (20.00%)  2 1/6 (16.67%)  2 1/8 (12.50%)  1 0/4 (0.00%)  0
Peripheral sensory neuropathy  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
Tremor  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1
Psychiatric disorders         
Anxiety  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
Insomnia  1  1/5 (20.00%)  1 1/6 (16.67%)  1 1/8 (12.50%)  2 2/4 (50.00%)  3
Renal and urinary disorders         
Glucosuria  1  1/5 (20.00%)  2 0/6 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0
Hematuria  1  1/5 (20.00%)  1 0/6 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
Proteinuria  1  0/5 (0.00%)  0 1/6 (16.67%)  2 0/8 (0.00%)  0 1/4 (25.00%)  1
Renal and urinary disorders - Other, creatinine clearance decreased  1  2/5 (40.00%)  2 1/6 (16.67%)  1 2/8 (25.00%)  2 0/4 (0.00%)  0
Urine discoloration  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0
Renal and urinary disorders- Other, specify  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Allergic rhinitis  1  1/5 (20.00%)  1 0/6 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
Cough  1  3/5 (60.00%)  4 0/6 (0.00%)  0 4/8 (50.00%)  4 0/4 (0.00%)  0
Dyspnea  1  0/5 (0.00%)  0 2/6 (33.33%)  3 1/8 (12.50%)  1 0/4 (0.00%)  0
Hiccups  1  0/5 (0.00%)  0 1/6 (16.67%)  2 0/8 (0.00%)  0 0/4 (0.00%)  0
Laryngeal hemorrhage  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
Nasal congestion  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0
Pleural effusion  1  0/5 (0.00%)  0 2/6 (33.33%)  3 2/8 (25.00%)  9 0/4 (0.00%)  0
Productive cough  1  0/5 (0.00%)  0 1/6 (16.67%)  1 2/8 (25.00%)  2 0/4 (0.00%)  0
Rhinorrhea  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  2
Sore throat  1  0/5 (0.00%)  0 1/6 (16.67%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0
Wheezing  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dry skin  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1
Hyperhidrosis  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 1/4 (25.00%)  1
Pruritus  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1
Rash maculo-papular  1  0/5 (0.00%)  0 1/6 (16.67%)  2 0/8 (0.00%)  0 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, skin disorders, others facial erythema  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
Skin ulceration  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1
Thrush  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0
Vascular disorders         
Hypertension  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 2/4 (50.00%)  2
Hypotension  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  2
Thromboembolic event  1  1/5 (20.00%)  1 0/6 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
1
Term from vocabulary, CTCAE (5.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Raffit Hassan
Organization: National Cancer Institute
Phone: 240-760-6232
EMail: raffit_hassan@nih.gov
Layout table for additonal information
Responsible Party: Raffit Hassan, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03531840    
Other Study ID Numbers: 180097
18-C-0097
First Submitted: May 18, 2018
First Posted: May 22, 2018
Results First Submitted: December 28, 2020
Results First Posted: March 11, 2021
Last Update Posted: April 9, 2021