Trial Outcomes & Findings for CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma (NCT NCT04217317)
NCT ID: NCT04217317
Last Updated: 2025-05-02
Results Overview
Number of patients successfully able to complete 80% (at least 5 of 6 planned cycles) of their therapy regimens.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
up to 6 cycles, up to 24 weeks after first dose
Results posted on
2025-05-02
Participant Flow
Participant milestones
| Measure |
CPI-613 in Combination With Bendamustine
CPI-613 at 2500 mg/m2 is infused intravenously (IV) via a central catheter over 2 hrs on Days 1and 2. Bendamustine at 90 mg/m2 is infused IV over 10 minutes on Days 1 and 2 of each treatment cycle, given immediately after CPI-613 administration.
CPI 613: CPI-613 is to be given as 2-hr IV infusion via a central venous catheter. The starting dose of CPI-613 will be 2500 mg/m2 which was determined to be the MTD in the previous phase I clinical trial.
Bendamustine: Bendamustine at 90 mg/m2 is infused by IV over 10 minutes on Days 1 and 2 of each treatment cycle. Bendamustine is given immediately after CPI-613 administration.
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|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
CPI-613 in Combination With Bendamustine
CPI-613 at 2500 mg/m2 is infused intravenously (IV) via a central catheter over 2 hrs on Days 1and 2. Bendamustine at 90 mg/m2 is infused IV over 10 minutes on Days 1 and 2 of each treatment cycle, given immediately after CPI-613 administration.
CPI 613: CPI-613 is to be given as 2-hr IV infusion via a central venous catheter. The starting dose of CPI-613 will be 2500 mg/m2 which was determined to be the MTD in the previous phase I clinical trial.
Bendamustine: Bendamustine at 90 mg/m2 is infused by IV over 10 minutes on Days 1 and 2 of each treatment cycle. Bendamustine is given immediately after CPI-613 administration.
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|---|---|
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Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
CPI-613 in Combination With Bendamustine
n=6 Participants
CPI-613 at 2500 mg/m2 is infused intravenously (IV) via a central catheter over 2 hrs on Days 1and 2. Bendamustine at 90 mg/m2 is infused IV over 10 minutes on Days 1 and 2 of each treatment cycle, given immediately after CPI-613 administration.
CPI 613: CPI-613 is to be given as 2-hr IV infusion via a central venous catheter. The starting dose of CPI-613 will be 2500 mg/m2 which was determined to be the MTD in the previous phase I clinical trial.
Bendamustine: Bendamustine at 90 mg/m2 is infused by IV over 10 minutes on Days 1 and 2 of each treatment cycle. Bendamustine is given immediately after CPI-613 administration.
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|---|---|
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Age, Continuous
|
61.7 years
STANDARD_DEVIATION 9.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
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6 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 6 cycles, up to 24 weeks after first doseNumber of patients successfully able to complete 80% (at least 5 of 6 planned cycles) of their therapy regimens.
Outcome measures
| Measure |
CPI-613 in Combination With Bendamustine
n=6 Participants
CPI-613 at 2500 mg/m2 is infused intravenously (IV) via a central catheter over 2 hrs on Days 1and 2. Bendamustine at 90 mg/m2 is infused IV over 10 minutes on Days 1 and 2 of each treatment cycle, given immediately after CPI-613 administration.
CPI 613: CPI-613 is to be given as 2-hr IV infusion via a central venous catheter. The starting dose of CPI-613 will be 2500 mg/m2 which was determined to be the MTD in the previous phase I clinical trial.
Bendamustine: Bendamustine at 90 mg/m2 is infused by IV over 10 minutes on Days 1 and 2 of each treatment cycle. Bendamustine is given immediately after CPI-613 administration.
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|---|---|
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Number of Participants To Successfully Complete Therapy Regimen
|
3 Participants
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SECONDARY outcome
Timeframe: Patients are monitored for best overall response during and after study treatment. Follow-up for response ranged from 2 to 6 months after start of treatment.Overall response rate is defined as the proportion of patients who achieve a best overall response complete response or partial response during or following study treatment. Response derived from the Lugano classification for PTCL patients and Global Response Score for CTCL (MF/SS) patients. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: The Lugano classification.
Outcome measures
| Measure |
CPI-613 in Combination With Bendamustine
n=6 Participants
CPI-613 at 2500 mg/m2 is infused intravenously (IV) via a central catheter over 2 hrs on Days 1and 2. Bendamustine at 90 mg/m2 is infused IV over 10 minutes on Days 1 and 2 of each treatment cycle, given immediately after CPI-613 administration.
CPI 613: CPI-613 is to be given as 2-hr IV infusion via a central venous catheter. The starting dose of CPI-613 will be 2500 mg/m2 which was determined to be the MTD in the previous phase I clinical trial.
Bendamustine: Bendamustine at 90 mg/m2 is infused by IV over 10 minutes on Days 1 and 2 of each treatment cycle. Bendamustine is given immediately after CPI-613 administration.
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|---|---|
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Overall Response Rate
|
1 Participants
|
SECONDARY outcome
Timeframe: Patients are monitored for response during and after study treatment. Follow-up for response ranged from 2 to 6 months after start of treatment.Disease control rate defined as the proportion of patients who achieve a best overall response of complete response, partial response, or stable disease (SD). Best overall response of stable disease must have met the response stable disease criteria at least once ≥12 weeks after start of study treatment. Response derived from the Lugano classification for PTCL patients and Global Response Score for CTCL (MF/SS) patients
Outcome measures
| Measure |
CPI-613 in Combination With Bendamustine
n=6 Participants
CPI-613 at 2500 mg/m2 is infused intravenously (IV) via a central catheter over 2 hrs on Days 1and 2. Bendamustine at 90 mg/m2 is infused IV over 10 minutes on Days 1 and 2 of each treatment cycle, given immediately after CPI-613 administration.
CPI 613: CPI-613 is to be given as 2-hr IV infusion via a central venous catheter. The starting dose of CPI-613 will be 2500 mg/m2 which was determined to be the MTD in the previous phase I clinical trial.
Bendamustine: Bendamustine at 90 mg/m2 is infused by IV over 10 minutes on Days 1 and 2 of each treatment cycle. Bendamustine is given immediately after CPI-613 administration.
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|---|---|
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Disease Control Rate
|
3 Participants
|
SECONDARY outcome
Timeframe: Patients are monitored for response during and after study treatment. Follow-up for response ranged from 2 to 6 months after start of treatment.Population: patients who had a complete or partial response during the study.
Duration of Response will be defined for responders (patients with a best overall response of complete response or partial response). It is the time from the date of the first documented complete response or partial response until the date of the first date of progressive disease, or death due to any cause, whichever occurs first. If a patient has not progressed or died by the analysis cutoff date, duration of response will be censored at the time of the last adequate tumor assessment on or before the cutoff date. Response derived from the Lugano classification for PTCL patients and Global Response Score for CTCL (MF/SS) patients.
Outcome measures
| Measure |
CPI-613 in Combination With Bendamustine
n=1 Participants
CPI-613 at 2500 mg/m2 is infused intravenously (IV) via a central catheter over 2 hrs on Days 1and 2. Bendamustine at 90 mg/m2 is infused IV over 10 minutes on Days 1 and 2 of each treatment cycle, given immediately after CPI-613 administration.
CPI 613: CPI-613 is to be given as 2-hr IV infusion via a central venous catheter. The starting dose of CPI-613 will be 2500 mg/m2 which was determined to be the MTD in the previous phase I clinical trial.
Bendamustine: Bendamustine at 90 mg/m2 is infused by IV over 10 minutes on Days 1 and 2 of each treatment cycle. Bendamustine is given immediately after CPI-613 administration.
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|---|---|
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Duration of Response
|
2.3 months
Interval 2.3 to 2.3
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SECONDARY outcome
Timeframe: Patients are monitored for progression during and after study treatment. Follow-up for response ranged from 2 to 6 months after start of treatment.Progression free survival defined as the time from the start of study treatment until the first date of progressive disease, or death due to any cause, whichever occurs first. If a patient has not progressed or died by the analysis cutoff date, progression free survival will be censored at the time of the last adequate tumor assessment on or before the cutoff date. Response derived from the Lugano classification for PTCL patients and Global Response Score for CTCL (MF/SS) patients
Outcome measures
| Measure |
CPI-613 in Combination With Bendamustine
n=6 Participants
CPI-613 at 2500 mg/m2 is infused intravenously (IV) via a central catheter over 2 hrs on Days 1and 2. Bendamustine at 90 mg/m2 is infused IV over 10 minutes on Days 1 and 2 of each treatment cycle, given immediately after CPI-613 administration.
CPI 613: CPI-613 is to be given as 2-hr IV infusion via a central venous catheter. The starting dose of CPI-613 will be 2500 mg/m2 which was determined to be the MTD in the previous phase I clinical trial.
Bendamustine: Bendamustine at 90 mg/m2 is infused by IV over 10 minutes on Days 1 and 2 of each treatment cycle. Bendamustine is given immediately after CPI-613 administration.
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|---|---|
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Progression Free Survival
|
2.7 months
Interval 2.1 to 6.1
|
SECONDARY outcome
Timeframe: Maximum observed follow-up of 3 years 9 monthsOverall survival is measured from the start of study treatment until death due to any cause. If a patient is not known to have died at the date of the analysis cut-off, overall survival will be censored at the last date that: Patient is documented to be alive. At the time of single cell sequencing.
Outcome measures
| Measure |
CPI-613 in Combination With Bendamustine
n=6 Participants
CPI-613 at 2500 mg/m2 is infused intravenously (IV) via a central catheter over 2 hrs on Days 1and 2. Bendamustine at 90 mg/m2 is infused IV over 10 minutes on Days 1 and 2 of each treatment cycle, given immediately after CPI-613 administration.
CPI 613: CPI-613 is to be given as 2-hr IV infusion via a central venous catheter. The starting dose of CPI-613 will be 2500 mg/m2 which was determined to be the MTD in the previous phase I clinical trial.
Bendamustine: Bendamustine at 90 mg/m2 is infused by IV over 10 minutes on Days 1 and 2 of each treatment cycle. Bendamustine is given immediately after CPI-613 administration.
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|---|---|
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Overall Survival
|
7.5 months
Interval 6.5 to 17.1
|
Adverse Events
CPI-613 in Combination With Bendamustine
Serious events: 2 serious events
Other events: 6 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
CPI-613 in Combination With Bendamustine
n=6 participants at risk
CPI-613 at 2500 mg/m2 is infused intravenously (IV) via a central catheter over 2 hrs on Days 1and 2. Bendamustine at 90 mg/m2 is infused IV over 10 minutes on Days 1 and 2 of each treatment cycle, given immediately after CPI-613 administration.
CPI 613: CPI-613 is to be given as 2-hr IV infusion via a central venous catheter. The starting dose of CPI-613 will be 2500 mg/m2 which was determined to be the MTD in the previous phase I clinical trial.
Bendamustine: Bendamustine at 90 mg/m2 is infused by IV over 10 minutes on Days 1 and 2 of each treatment cycle. Bendamustine is given immediately after CPI-613 administration.
|
|---|---|
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Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Infections and infestations
Infections and infestations - Other: Catheter related infection
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Infections and infestations
Sepsis
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Infections and infestations
Skin infection
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Infections and infestations
Upper respiratory infection
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Investigations
White blood cell decreased
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
Other adverse events
| Measure |
CPI-613 in Combination With Bendamustine
n=6 participants at risk
CPI-613 at 2500 mg/m2 is infused intravenously (IV) via a central catheter over 2 hrs on Days 1and 2. Bendamustine at 90 mg/m2 is infused IV over 10 minutes on Days 1 and 2 of each treatment cycle, given immediately after CPI-613 administration.
CPI 613: CPI-613 is to be given as 2-hr IV infusion via a central venous catheter. The starting dose of CPI-613 will be 2500 mg/m2 which was determined to be the MTD in the previous phase I clinical trial.
Bendamustine: Bendamustine at 90 mg/m2 is infused by IV over 10 minutes on Days 1 and 2 of each treatment cycle. Bendamustine is given immediately after CPI-613 administration.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
4/6 • Number of events 9 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Cardiac disorders
Cardiac disorders - Other: BASELINE MURMUR
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Cardiac disorders
Palpitations
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Number of events 2 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
6/6 • Number of events 7 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 2 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
General disorders
Edema limbs
|
66.7%
4/6 • Number of events 4 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
General disorders
Fatigue
|
83.3%
5/6 • Number of events 5 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
General disorders
Pain
|
33.3%
2/6 • Number of events 2 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Infections and infestations
Bacteremia
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Infections and infestations
Infections and infestations - Other: FUNGAL POSITIVE SPUTUM
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Infections and infestations
Infections and infestations - Other: INCREASED MONOCYTES
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
2/6 • Number of events 2 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
2/6 • Number of events 2 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • Number of events 2 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Investigations
Blood bilirubin increased
|
50.0%
3/6 • Number of events 5 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
2/6 • Number of events 2 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Investigations
Lymphocyte count decreased
|
83.3%
5/6 • Number of events 11 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Investigations
Neutrophil count decreased
|
50.0%
3/6 • Number of events 7 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Investigations
Platelet count decreased
|
50.0%
3/6 • Number of events 10 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Investigations
Weight gain
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Investigations
White blood cell decreased
|
33.3%
2/6 • Number of events 7 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
3/6 • Number of events 3 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
2/6 • Number of events 2 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
3/6 • Number of events 4 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
3/6 • Number of events 4 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
66.7%
4/6 • Number of events 10 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
3/6 • Number of events 3 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
66.7%
4/6 • Number of events 7 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
4/6 • Number of events 6 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
2/6 • Number of events 2 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • Number of events 2 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
3/6 • Number of events 3 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6 • Number of events 2 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Renal and urinary disorders
Chronic kidney disease
|
16.7%
1/6 • Number of events 2 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Renal and urinary disorders
Urinary frequency
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Renal and urinary disorders
Urine discoloration
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 2 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
3/6 • Number of events 5 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other: Bumps on head and face
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other: NEW SKIN LESIONS
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
16.7%
1/6 • Number of events 1 • Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.
|
Additional Information
Study Coordinator
Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-713-5878
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place