Trial Outcomes & Findings for CPI-613 in Treating Patients With Myelodysplastic Syndromes Who Failed Previous Therapy (NCT NCT01902381)
NCT ID: NCT01902381
Last Updated: 2024-10-17
Results Overview
Response rate (RR), defined as the combined of complete remission (CR), marrow CR, partial remission (PR), or stable disease (SD), as described by Cheson, et al. (2006). The number of patients achieving RR will be presented. Complete remission - Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines; Marrow CR - Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment Partial remission - All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still \> 5%, cellularity and morphology not relevant Stable disease - Failure to achieve at least PR, but no evidence of progression for \> 8 wks
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2024-10-17
Participant Flow
Participant milestones
| Measure |
Treatment (6, 8-bis(Benzylthio) Octanoic Acid)
Patients receive treatment 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
6,8-bis(benzylthio)octanoic acid: Given IV
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (6, 8-bis(Benzylthio) Octanoic Acid)
Patients receive treatment 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
6,8-bis(benzylthio)octanoic acid: Given IV
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
CPI-613 in Treating Patients With Myelodysplastic Syndromes Who Failed Previous Therapy
Baseline characteristics by cohort
| Measure |
Treatment (6, 8-bis(Benzylthio) Octanoic Acid)
n=12 Participants
Patients receive treatment 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
6,8-bis(benzylthio)octanoic acid: Given IV
|
|---|---|
|
Age, Continuous
|
71.2 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsResponse rate (RR), defined as the combined of complete remission (CR), marrow CR, partial remission (PR), or stable disease (SD), as described by Cheson, et al. (2006). The number of patients achieving RR will be presented. Complete remission - Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines; Marrow CR - Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment Partial remission - All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still \> 5%, cellularity and morphology not relevant Stable disease - Failure to achieve at least PR, but no evidence of progression for \> 8 wks
Outcome measures
| Measure |
Treatment (6, 8-bis(Benzylthio) Octanoic Acid)
n=12 Participants
Patients receive treatment 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
6,8-bis(benzylthio)octanoic acid: Given IV
|
|---|---|
|
Response Rate (RR), Defined as the Combined Rate of Complete Remission (CR), Marrow CR, Partial Remission (PR), or Stable Disease (SD), as Described by Cheson, et al. (2006)
|
11 Participants
|
SECONDARY outcome
Timeframe: During treatment, a median of 4 months with a maximum of 40 monthsSafety profile of CPI-613, based on evaluation of symptoms, vital signs, ECOG performance status and survival, clinical chemistry, hematology, and coagulation, assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0. Toxicities related to the treatment will be examined by looking at each toxicity identified by grade (highest grade of each toxicity per patient so that there is only one event attributed to each patient for a given toxicity).
Outcome measures
| Measure |
Treatment (6, 8-bis(Benzylthio) Octanoic Acid)
n=12 Participants
Patients receive treatment 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
6,8-bis(benzylthio)octanoic acid: Given IV
|
|---|---|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Sinus bradycardia · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Eye disorders - Other · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Fatigue · Grade 3
|
2 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Alanine aminotransferase increased · Unobserved
|
9 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
White blood cell decreased · Unobserved
|
6 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypocalcemia · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypocalcemia · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypomagnesemia · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dyspnea · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Anemia · Unobserved
|
5 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Anemia · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Anemia · Grade 2
|
2 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Anemia · Grade 3
|
2 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Anemia · Grade 4
|
3 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Febrile neutropenia · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Febrile neutropenia · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Febrile neutropenia · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Febrile neutropenia · Grade 3
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Febrile neutropenia · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Sinus bradycardia · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Sinus bradycardia · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Sinus bradycardia · Grade 3
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Sinus bradycardia · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Cardiac disorders - Other · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Cardiac disorders - Other · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Cardiac disorders - Other · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Cardiac disorders - Other · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Cardiac disorders - Other · Grade 4
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dry eye · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dry eye · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dry eye · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dry eye · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dry eye · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Eye disorders - Other · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Eye disorders - Other · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Eye disorders - Other · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Eye disorders - Other · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Eye disorders - Right eye subconjunctival hemorrhage · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Eye disorders - Right eye subconjunctival hemorrhage · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Eye disorders - Right eye subconjunctival hemorrhage · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Eye disorders - Right eye subconjunctival hemorrhage · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Eye disorders - Right eye subconjunctival hemorrhage · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Constipation · Unobserved
|
10 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Constipation · Grade 1
|
2 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Constipation · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Constipation · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Constipation · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Diarrhea · Unobserved
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Diarrhea · Grade 1
|
5 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Diarrhea · Grade 2
|
5 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Diarrhea · Grade 3
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Diarrhea · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Gastroesophageal reflux disease · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Gastroesophageal reflux disease · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Gastroesophageal reflux disease · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Gastroesophageal reflux disease · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Gastroesophageal reflux disease · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Nausea · Unobserved
|
4 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Nausea · Grade 1
|
5 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Nausea · Grade 2
|
3 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Nausea · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Nausea · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Taste alteration (dysgeusia) · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Taste alteration (dysgeusia) · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Taste alteration (dysgeusia) · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Taste alteration (dysgeusia) · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Taste alteration (dysgeusia) · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Vomiting · Unobserved
|
8 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Vomiting · Grade 1
|
4 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Vomiting · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Vomiting · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Vomiting · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Chills · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Chills · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Chills · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Chills · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Chills · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Edema limbs · Unobserved
|
10 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Edema limbs · Grade 1
|
2 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Edema limbs · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Edema limbs · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Edema limbs · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Fatigue · Unobserved
|
5 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Fatigue · Grade 1
|
2 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Fatigue · Grade 2
|
3 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Fatigue · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Fever · Unobserved
|
9 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Fever · Grade 1
|
3 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Fever · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Fever · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Fever · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Malaise · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Malaise · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Malaise · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Malaise · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Malaise · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lung infection · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lung infection · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lung infection · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lung infection · Grade 3
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lung infection · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Mucosal infection · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Mucosal infection · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Mucosal infection · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Mucosal infection · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Mucosal infection · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Sinusitis · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Sinusitis · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Sinusitis · Grade 2
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Sinusitis · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Sinusitis · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Bruising · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Bruising · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Bruising · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Bruising · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Bruising · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Alanine aminotransferase increased · Grade 1
|
3 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Alanine aminotransferase increased · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Alanine aminotransferase increased · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Alanine aminotransferase increased · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Alkaline phosphatase increased · Unobserved
|
10 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Alkaline phosphatase increased · Grade 1
|
2 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Alkaline phosphatase increased · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Alkaline phosphatase increased · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Alkaline phosphatase increased · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Aspartate aminotransferase increased · Unobserved
|
9 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Aspartate aminotransferase increased · Grade 1
|
3 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Aspartate aminotransferase increased · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Aspartate aminotransferase increased · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Aspartate aminotransferase increased · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Blood bilirubin increased · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Blood bilirubin increased · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Blood bilirubin increased · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Blood bilirubin increased · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Blood bilirubin increased · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Creatinine increased · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Creatinine increased · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Creatinine increased · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Creatinine increased · Grade 3
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Creatinine increased · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Electrocardiogram QT corrected interval prolonged · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Electrocardiogram QT corrected interval prolonged · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Electrocardiogram QT corrected interval prolonged · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Electrocardiogram QT corrected interval prolonged · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Electrocardiogram QT corrected interval prolonged · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lymphocyte count decreased · Unobserved
|
7 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lymphocyte count decreased · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lymphocyte count decreased · Grade 2
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lymphocyte count decreased · Grade 3
|
2 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lymphocyte count decreased · Grade 4
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lymphocyte count increased · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lymphocyte count increased · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lymphocyte count increased · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lymphocyte count increased · Grade 3
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lymphocyte count increased · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Neutrophil count decreased · Unobserved
|
7 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Neutrophil count decreased · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Neutrophil count decreased · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Neutrophil count decreased · Grade 3
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Neutrophil count decreased · Grade 4
|
4 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Platelet count decreased · Unobserved
|
6 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Platelet count decreased · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Platelet count decreased · Grade 2
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Platelet count decreased · Grade 3
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Platelet count decreased · Grade 4
|
4 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
White blood cell decreased · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
White blood cell decreased · Grade 2
|
2 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
White blood cell decreased · Grade 3
|
3 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
White blood cell decreased · Grade 4
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Anorexia · Unobserved
|
9 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Anorexia · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Anorexia · Grade 2
|
3 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Anorexia · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Anorexia · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypercalcemia · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypercalcemia · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypercalcemia · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypercalcemia · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypercalcemia · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hyperglycemia · Unobserved
|
8 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hyperglycemia · Grade 1
|
2 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hyperglycemia · Grade 2
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hyperglycemia · Grade 3
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hyperglycemia · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypoalbuminemia · Unobserved
|
10 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypoalbuminemia · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypoalbuminemia · Grade 2
|
2 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypoalbuminemia · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypoalbuminemia · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypocalcemia · Grade 2
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypocalcemia · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypocalcemia · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypomagnesemia · Unobserved
|
9 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypomagnesemia · Grade 1
|
3 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypomagnesemia · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypomagnesemia · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hyponatremia · Unobserved
|
10 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hyponatremia · Grade 1
|
2 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hyponatremia · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hyponatremia · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hyponatremia · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Generalized muscle weakness · Unobserved
|
8 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Generalized muscle weakness · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Generalized muscle weakness · Grade 2
|
2 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Generalized muscle weakness · Grade 3
|
2 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Generalized muscle weakness · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Pain in extremity · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Pain in extremity · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Pain in extremity · Grade 2
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Pain in extremity · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Pain in extremity · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Musculoskeletal and connective tissue disorder - Other · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Musculoskeletal and connective tissue disorder - Other · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Musculoskeletal and connective tissue disorder - Other · Grade 2
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Musculoskeletal and connective tissue disorder - Other · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Musculoskeletal and connective tissue disorder - Other · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Cognitive disturbance · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Cognitive disturbance · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Cognitive disturbance · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Cognitive disturbance · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Cognitive disturbance · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dizziness · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dizziness · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dizziness · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dizziness · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dizziness · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dysgeusia · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dysgeusia · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dysgeusia · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dysgeusia · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dysgeusia · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lethargy · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lethargy · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lethargy · Grade 2
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lethargy · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Lethargy · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Memory impairment · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Memory impairment · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Memory impairment · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Memory impairment · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Memory impairment · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Seizure · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Seizure · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Seizure · Grade 2
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Seizure · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Seizure · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hematuria · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hematuria · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hematuria · Grade 2
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hematuria · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hematuria · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Renal and urinary disorders - Other · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Renal and urinary disorders - Other · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Renal and urinary disorders - Other · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Renal and urinary disorders - Other · Grade 3
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Renal and urinary disorders - Other · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dyspnea · Unobserved
|
10 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dyspnea · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dyspnea · Grade 2
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Dyspnea · Grade 3
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Epistaxis · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Epistaxis · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Epistaxis · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Epistaxis · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Epistaxis · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Erythema multiforme · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Erythema multiforme · Grade 1
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Erythema multiforme · Grade 2
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Erythema multiforme · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Erythema multiforme · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Skin and subcutaneous tissue disorders - Dry Skin · Unobserved
|
11 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Skin and subcutaneous tissue disorders - Dry Skin · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Skin and subcutaneous tissue disorders - Dry Skin · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Skin and subcutaneous tissue disorders - Dry Skin · Grade 3
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Skin and subcutaneous tissue disorders - Dry Skin · Grade 4
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypotension · Unobserved
|
10 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypotension · Grade 1
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypotension · Grade 2
|
0 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypotension · Grade 3
|
1 Participants
|
|
Safety Profile of CPI-613, Based on Evaluation of Symptoms, Vital Signs, ECOG Performance Status and Survival, Clinical Chemistry, Hematology, and Coagulation, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0
Hypotension · Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 and 12 months post treatment startSurvival curves for PFS using Kaplan-Meier techniques will be estimated. In addition, the 6 month and 1-year PFS rates for these participants will be estimated. Disease progression: For patients with: Less than 5% blasts: ≥ 50% increase in blasts to \> 5% blasts 5%-10% blasts: ≥ 50% increase to \> 10% blasts 10%-20% blasts: ≥ 50% increase to \> 20% blasts 20%-30% blasts: ≥ 50% increase to \> 30% blasts Any of the following: At least 50% decrement from maximum remission/response in granulocytes or platelets Reduction in Hgb by ≥ 2 g/dL Transfusion dependence Survival Endpoints: Overall: death from any cause Event free: failure or death from any cause PFS: disease progression or death from MDS DFS: time to relapse Cause-specific death: death related to MDS
Outcome measures
| Measure |
Treatment (6, 8-bis(Benzylthio) Octanoic Acid)
n=12 Participants
Patients receive treatment 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
6,8-bis(benzylthio)octanoic acid: Given IV
|
|---|---|
|
Progression-free Survival (PFS)
6 Month
|
65.6 Percentage of participants
Interval 38.2 to 93.1
|
|
Progression-free Survival (PFS)
12 Month
|
46.9 Percentage of participants
Interval 17.4 to 76.3
|
SECONDARY outcome
Timeframe: 6 and 12 months post treatment startSurvival curves for OS using Kaplan-Meier techniques will be estimated. In addition, the 6 month and 1-year OS rates for these participants will be estimated.
Outcome measures
| Measure |
Treatment (6, 8-bis(Benzylthio) Octanoic Acid)
n=12 Participants
Patients receive treatment 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
6,8-bis(benzylthio)octanoic acid: Given IV
|
|---|---|
|
Overall Survival (OS)
6 Month OS
|
81.8 overall survival percentage
Interval 59.0 to 100.0
|
|
Overall Survival (OS)
12 Month OS
|
54.6 overall survival percentage
Interval 25.1 to 84.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Patients with blood transfusions at baseline
Number of patients who achieve a reduction in blood transfusion requirements.
Outcome measures
| Measure |
Treatment (6, 8-bis(Benzylthio) Octanoic Acid)
n=9 Participants
Patients receive treatment 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
6,8-bis(benzylthio)octanoic acid: Given IV
|
|---|---|
|
Number of Patients Who Achieve a Reduction in Blood Transfusion Requirements
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsNumber of patients who achieve hematologic improvement (HI), as defined by Cheson, et al. (2006). Criteria: Erythroid response (pretreatment, \< 11 g/dL) - Hgb increase by ≥ 1.5 g/dL. Platelet response (pretreatment, \< 100 × 109/L) - Absolute increase of ≥ 30 × 109/L for patients starting with \> 20 × 109/L platelets. Increase from \< 20 × 109/L to \> 20 × 109/L and by at least 100% Neutrophil response (pretreatment, \< 1.0 × 109/L) - At least 100% increase and an absolute increase \> 0.5 × 109/L Progression or relapse after HI - At least 1 of the following: At least 50% decrement from maximum response levels in granulocytes or platelets Reduction in Hgb by ≥ 1.5 g/dL
Outcome measures
| Measure |
Treatment (6, 8-bis(Benzylthio) Octanoic Acid)
n=12 Participants
Patients receive treatment 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
6,8-bis(benzylthio)octanoic acid: Given IV
|
|---|---|
|
Number of Patients Who Achieve Hematologic Improvement (HI), as Defined by Cheson, et al. (2006)
|
3 Participants
|
Adverse Events
Treatment (6, 8-bis(Benzylthio) Octanoic Acid)
Serious events: 2 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (6, 8-bis(Benzylthio) Octanoic Acid)
n=12 participants at risk
Patients receive treatment 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
6,8-bis(benzylthio)octanoic acid: Given IV
|
|---|---|
|
Cardiac disorders
Sinus bradycardia
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Cardiac disorders
Cardiac disorders - Other:
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
General disorders
Death NOS
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
Other adverse events
| Measure |
Treatment (6, 8-bis(Benzylthio) Octanoic Acid)
n=12 participants at risk
Patients receive treatment 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
6,8-bis(benzylthio)octanoic acid: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
12/12 • Number of events 97 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.3%
1/12 • Number of events 3 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Blood and lymphatic system disorders
Lymphopenia (1-5.1)
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Cardiac disorders
Atrial flutter
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Cardiac disorders
Chest pain - cardiac
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
2/12 • Number of events 3 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Cardiac disorders
Cardiac disorders - Other: Murmur
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Ear and labyrinth disorders
Ear pain
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Ear and labyrinth disorders
Hearing impaired
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Eye disorders
Blurred vision
|
33.3%
4/12 • Number of events 5 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Eye disorders
Dry eye
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Eye disorders
Photophobia
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Eye disorders
Eye disorders - Other:
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Eye disorders
Eye disorders - Other: Right eye subconjunctival hemorrhage
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
3/12 • Number of events 7 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Anal hemorrhage
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Anal ulcer
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Ascites
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Constipation
|
41.7%
5/12 • Number of events 23 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
12/12 • Number of events 49 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • Number of events 2 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Hemorrhoids
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
4/12 • Number of events 5 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Nausea
|
66.7%
8/12 • Number of events 27 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Oral hemorrhage
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Oral pain
|
8.3%
1/12 • Number of events 2 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Rectal pain
|
16.7%
2/12 • Number of events 4 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
4/12 • Number of events 5 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other:
|
16.7%
2/12 • Number of events 4 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other: Indigestion
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
General disorders
Chills
|
25.0%
3/12 • Number of events 3 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
General disorders
Edema face
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
General disorders
Edema limbs
|
50.0%
6/12 • Number of events 12 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
General disorders
Fatigue
|
91.7%
11/12 • Number of events 53 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
General disorders
Fever
|
33.3%
4/12 • Number of events 6 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
General disorders
Gait disturbance
|
33.3%
4/12 • Number of events 10 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
General disorders
Malaise
|
33.3%
4/12 • Number of events 4 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
General disorders
Pain
|
41.7%
5/12 • Number of events 7 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
General disorders
General disorders and administration site conditions - Other:
|
16.7%
2/12 • Number of events 3 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
General disorders
General disorders and administration site conditions - Other: AE logs rec'd 2/18/15
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other: Hepatomegaly
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Immune system disorders
Allergic reaction
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Immune system disorders
Immune system disorders - Other:
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Infections and infestations
Anorectal infection
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Infections and infestations
Bronchial infection
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Infections and infestations
Lung infection
|
33.3%
4/12 • Number of events 5 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Infections and infestations
Mucosal infection
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Infections and infestations
Sepsis
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Infections and infestations
Sinusitis
|
16.7%
2/12 • Number of events 3 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Infections and infestations
Upper respiratory infection
|
16.7%
2/12 • Number of events 2 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Infections and infestations
Urinary tract infection
|
33.3%
4/12 • Number of events 5 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Infections and infestations
Vaginal infection
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Infections and infestations
Infections and infestations - Other:
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Injury, poisoning and procedural complications
Bruising
|
41.7%
5/12 • Number of events 11 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
3/12 • Number of events 3 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other:
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Investigations
Activated partial thromboplastin time prolonged
|
50.0%
6/12 • Number of events 12 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
6/12 • Number of events 41 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Investigations
Alkaline phosphatase increased
|
41.7%
5/12 • Number of events 12 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Investigations
Aspartate aminotransferase increased
|
58.3%
7/12 • Number of events 35 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Investigations
Blood bilirubin increased
|
58.3%
7/12 • Number of events 14 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Investigations
Creatinine increased
|
8.3%
1/12 • Number of events 2 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
8.3%
1/12 • Number of events 2 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Investigations
Haptoglobin decreased
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Investigations
Lymphocyte count decreased
|
100.0%
12/12 • Number of events 76 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Investigations
Lymphocyte count increased
|
16.7%
2/12 • Number of events 2 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Investigations
Neutrophil count decreased
|
91.7%
11/12 • Number of events 61 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Investigations
Platelet count decreased
|
100.0%
12/12 • Number of events 96 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Investigations
White blood cell decreased
|
100.0%
12/12 • Number of events 74 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Metabolism and nutrition disorders
Acidosis
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Metabolism and nutrition disorders
Alkalosis
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Metabolism and nutrition disorders
Anorexia
|
41.7%
5/12 • Number of events 13 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
2/12 • Number of events 4 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
12/12 • Number of events 93 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
6/12 • Number of events 21 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
66.7%
8/12 • Number of events 20 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Metabolism and nutrition disorders
Hypokalemia
|
41.7%
5/12 • Number of events 12 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
6/12 • Number of events 23 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Metabolism and nutrition disorders
Hyponatremia
|
75.0%
9/12 • Number of events 25 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
3/12 • Number of events 3 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Metabolism and nutrition disorders
Iron overload
|
33.3%
4/12 • Number of events 4 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other:
|
8.3%
1/12 • Number of events 2 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
4/12 • Number of events 5 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
41.7%
5/12 • Number of events 15 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • Number of events 2 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
2/12 • Number of events 2 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other:
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Nervous system disorders
Cognitive disturbance
|
25.0%
3/12 • Number of events 7 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Nervous system disorders
Dizziness
|
50.0%
6/12 • Number of events 13 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Nervous system disorders
Dysgeusia
|
16.7%
2/12 • Number of events 2 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Nervous system disorders
Dysphasia
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Nervous system disorders
Lethargy
|
16.7%
2/12 • Number of events 3 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Nervous system disorders
Memory impairment
|
25.0%
3/12 • Number of events 5 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Nervous system disorders
Paresthesia
|
8.3%
1/12 • Number of events 4 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Nervous system disorders
Peripheral motor neuropathy
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
3/12 • Number of events 3 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Nervous system disorders
Seizure
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Nervous system disorders
Sinus pain
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Nervous system disorders
Tremor
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Psychiatric disorders
Anxiety
|
33.3%
4/12 • Number of events 10 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Psychiatric disorders
Confusion
|
16.7%
2/12 • Number of events 3 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Psychiatric disorders
Hallucinations
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Number of events 3 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Renal and urinary disorders
Acute kidney injury
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Renal and urinary disorders
Chronic kidney disease
|
41.7%
5/12 • Number of events 15 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Renal and urinary disorders
Hematuria
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
4/12 • Number of events 5 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Renal and urinary disorders
Urinary frequency
|
25.0%
3/12 • Number of events 4 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Renal and urinary disorders
Urinary incontinence
|
25.0%
3/12 • Number of events 9 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Renal and urinary disorders
Renal and urinary disorders - Other:
|
25.0%
3/12 • Number of events 4 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Reproductive system and breast disorders
Pelvic pain
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
8/12 • Number of events 15 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
83.3%
10/12 • Number of events 36 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
4/12 • Number of events 7 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
3/12 • Number of events 3 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
3/12 • Number of events 4 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
3/12 • Number of events 3 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
25.0%
3/12 • Number of events 4 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
25.0%
3/12 • Number of events 4 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
2/12 • Number of events 2 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other:
|
25.0%
3/12 • Number of events 3 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other:
|
8.3%
1/12 • Number of events 2 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other: Dry Skin
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other: log rec'd 3/17/15
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other: log rec'd 3/17/15/ Arm Wound
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Vascular disorders
Hematoma
|
8.3%
1/12 • Number of events 1 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Vascular disorders
Hot flashes
|
8.3%
1/12 • Number of events 2 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Vascular disorders
Hypertension
|
16.7%
2/12 • Number of events 6 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Number of events 2 • During treatment, a median of 4 months with a maximum of 40 months.
Serious Adverse Events are defined as unexpected grade 4 and all grade 5
|
Additional Information
Principal Investigator
Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-713-5440
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place