Trial Outcomes & Findings for 9-ING-41 Plus Retifanlimab and Gemcitabine/Nab-Paclitaxel in Patients With Advanced Pancreatic Adenocarcinoma (NCT NCT05239182)
NCT ID: NCT05239182
Last Updated: 2025-07-17
Results Overview
Percentage of patients with stable disease (SD), Complete Response (CR), or Partial Response (PR) for ≥16 weeks during treatment. Per RECIST v1.1, (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Up to approximately 11 months from baseline
Results posted on
2025-07-17
Participant Flow
Participant milestones
| Measure |
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane
* intravenous (IV) infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine according to the gemcitabine label at a dose of 1000 mg per square meter, on days 1, 8, 15 of a 28-day cycle.
* Retifanlimab 500 mg IV on day 1 of a 28-day cycle. (Retifanlimab will be administered following gemcitabine/nab-paclitaxel.)
* 9-ING-41 administered at a dose of 9.3 mg/kg by IV infusion twice weekly on Days 1 and 4 of each week of a 28-day cycle. (9-ING-41 will be administered following retifanlimab.)
9-ING-41: 9-ING-41 is a small molecule potent selective GSK-3β inhibitor
Retifanlimab: Humanized, hinge-stabilized, IgG4κ monoclonal antibody that recognizes human PD-1.
Gemcitabine: cytotoxic chemotherapy agent
Abraxane: cytotoxic chemotherapy agent
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sex is 'Unknown' for one patient.
Baseline characteristics by cohort
| Measure |
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane
n=7 Participants
* intravenous (IV) infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine according to the gemcitabine label at a dose of 1000 mg per square meter, on days 1, 8, 15 of a 28-day cycle.
* Retifanlimab 500 mg IV on day 1 of a 28-day cycle. (Retifanlimab will be administered following gemcitabine/nab-paclitaxel.)
* 9-ING-41 administered at a dose of 9.3 mg/kg by IV infusion twice weekly on Days 1 and 4 of each week of a 28-day cycle. (9-ING-41 will be administered following retifanlimab.)
9-ING-41: 9-ING-41 is a small molecule potent selective GSK-3β inhibitor
Retifanlimab: Humanized, hinge-stabilized, IgG4κ monoclonal antibody that recognizes human PD-1.
Gemcitabine: cytotoxic chemotherapy agent
Abraxane: cytotoxic chemotherapy agent
|
|---|---|
|
Age, Continuous
|
57.14286 years
STANDARD_DEVIATION 5.607939 • n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=6 Participants • Sex is 'Unknown' for one patient.
|
|
Sex: Female, Male
Male
|
3 Participants
n=6 Participants • Sex is 'Unknown' for one patient.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 11 months from baselinePopulation: Treated patients who were radiologically evaluable.
Percentage of patients with stable disease (SD), Complete Response (CR), or Partial Response (PR) for ≥16 weeks during treatment. Per RECIST v1.1, (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane
n=6 Participants
* intravenous (IV) infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine according to the gemcitabine label at a dose of 1000 mg per square meter, on days 1, 8, 15 of a 28-day cycle.
* Retifanlimab 500 mg IV on day 1 of a 28-day cycle. (Retifanlimab will be administered following gemcitabine/nab-paclitaxel.)
* 9-ING-41 administered at a dose of 9.3 mg/kg by IV infusion twice weekly on Days 1 and 4 of each week of a 28-day cycle. (9-ING-41 will be administered following retifanlimab.)
9-ING-41: 9-ING-41 is a small molecule potent selective GSK-3β inhibitor
Retifanlimab: Humanized, hinge-stabilized, IgG4κ monoclonal antibody that recognizes human PD-1.
Gemcitabine: cytotoxic chemotherapy agent
Abraxane: cytotoxic chemotherapy agent
|
|---|---|
|
Disease Control Rate (DCR)
|
100 percentage of patients
|
SECONDARY outcome
Timeframe: Up to 12 months (from enrollment)Population: Treated patients who were radiologically evaluable.
Number of patients with Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) per RECIST v1.1 Per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane
n=6 Participants
* intravenous (IV) infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine according to the gemcitabine label at a dose of 1000 mg per square meter, on days 1, 8, 15 of a 28-day cycle.
* Retifanlimab 500 mg IV on day 1 of a 28-day cycle. (Retifanlimab will be administered following gemcitabine/nab-paclitaxel.)
* 9-ING-41 administered at a dose of 9.3 mg/kg by IV infusion twice weekly on Days 1 and 4 of each week of a 28-day cycle. (9-ING-41 will be administered following retifanlimab.)
9-ING-41: 9-ING-41 is a small molecule potent selective GSK-3β inhibitor
Retifanlimab: Humanized, hinge-stabilized, IgG4κ monoclonal antibody that recognizes human PD-1.
Gemcitabine: cytotoxic chemotherapy agent
Abraxane: cytotoxic chemotherapy agent
|
|---|---|
|
Best Response
Complete Response
|
0 Participants
|
|
Best Response
Partial Response
|
2 Participants
|
|
Best Response
Stable Disease
|
4 Participants
|
|
Best Response
Progressive Disease
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months (from enrollment)Population: Treated patients who were radiologically evaluable.
Percentage of patients with Complete Response (CR) or Partial Response (PR) per RECIST v1.1 Per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane
n=6 Participants
* intravenous (IV) infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine according to the gemcitabine label at a dose of 1000 mg per square meter, on days 1, 8, 15 of a 28-day cycle.
* Retifanlimab 500 mg IV on day 1 of a 28-day cycle. (Retifanlimab will be administered following gemcitabine/nab-paclitaxel.)
* 9-ING-41 administered at a dose of 9.3 mg/kg by IV infusion twice weekly on Days 1 and 4 of each week of a 28-day cycle. (9-ING-41 will be administered following retifanlimab.)
9-ING-41: 9-ING-41 is a small molecule potent selective GSK-3β inhibitor
Retifanlimab: Humanized, hinge-stabilized, IgG4κ monoclonal antibody that recognizes human PD-1.
Gemcitabine: cytotoxic chemotherapy agent
Abraxane: cytotoxic chemotherapy agent
|
|---|---|
|
Overall Response Rate (ORR)
|
33 percentage of patients
|
SECONDARY outcome
Timeframe: Up to 12 months (from enrollment)Population: All patients who receive at least one dose of 9-ING-41
Number of participants with overall treatment-related adverse events (AE) and/or serious adverse events (SAE) at least possibly related as assessed by CTCAE v5.0.
Outcome measures
| Measure |
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane
n=7 Participants
* intravenous (IV) infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine according to the gemcitabine label at a dose of 1000 mg per square meter, on days 1, 8, 15 of a 28-day cycle.
* Retifanlimab 500 mg IV on day 1 of a 28-day cycle. (Retifanlimab will be administered following gemcitabine/nab-paclitaxel.)
* 9-ING-41 administered at a dose of 9.3 mg/kg by IV infusion twice weekly on Days 1 and 4 of each week of a 28-day cycle. (9-ING-41 will be administered following retifanlimab.)
9-ING-41: 9-ING-41 is a small molecule potent selective GSK-3β inhibitor
Retifanlimab: Humanized, hinge-stabilized, IgG4κ monoclonal antibody that recognizes human PD-1.
Gemcitabine: cytotoxic chemotherapy agent
Abraxane: cytotoxic chemotherapy agent
|
|---|---|
|
Adverse Events and Serious Adverse Events
Throat pain
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Vomiting
|
2 participants
|
|
Adverse Events and Serious Adverse Events
Weight loss
|
4 participants
|
|
Adverse Events and Serious Adverse Events
White blood cell decreased
|
2 participants
|
|
Adverse Events and Serious Adverse Events
Alanine aminotransferase increased
|
2 participants
|
|
Adverse Events and Serious Adverse Events
Alopecia
|
2 participants
|
|
Adverse Events and Serious Adverse Events
Anemia
|
5 participants
|
|
Adverse Events and Serious Adverse Events
Anorexia
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Aspartate aminotransferase increased
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Ataxia
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Blurred vision
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Colitis
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Constipation
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Diarrhea
|
5 participants
|
|
Adverse Events and Serious Adverse Events
Dizziness
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Edema limbs
|
3 participants
|
|
Adverse Events and Serious Adverse Events
Eye disorder
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Fatigue
|
4 participants
|
|
Adverse Events and Serious Adverse Events
Febrile neutropenia
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Fever
|
2 participants
|
|
Adverse Events and Serious Adverse Events
Flu like symptoms
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Headache
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Hyperkalemia
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Hypokalemia
|
2 participants
|
|
Adverse Events and Serious Adverse Events
Hypomagnesemia
|
2 participants
|
|
Adverse Events and Serious Adverse Events
Hyponatremia
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Mucositis oral
|
3 participants
|
|
Adverse Events and Serious Adverse Events
Nail changes
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Nail discoloration
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Nausea
|
4 participants
|
|
Adverse Events and Serious Adverse Events
Neutrophil count decreased
|
4 participants
|
|
Adverse Events and Serious Adverse Events
Papulopustular rash
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Periorbital Dermatitis
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Peripheral motor neuropathy
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Peripheral sensory neuropathy
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Platelet count decreased
|
3 participants
|
|
Adverse Events and Serious Adverse Events
Pruritus
|
3 participants
|
|
Adverse Events and Serious Adverse Events
Rash maculo-papular
|
2 participants
|
|
Adverse Events and Serious Adverse Events
Sepsis
|
2 participants
|
|
Adverse Events and Serious Adverse Events
Skin and subcutaneous tissue disorders - Other, specify
|
1 participants
|
|
Adverse Events and Serious Adverse Events
Syncope
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 12 months (from enrollment)Population: Treated patients who were radiologically evaluable.
Time from documentation of tumor response to disease progression. Per RECISIT v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane
n=2 Participants
* intravenous (IV) infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine according to the gemcitabine label at a dose of 1000 mg per square meter, on days 1, 8, 15 of a 28-day cycle.
* Retifanlimab 500 mg IV on day 1 of a 28-day cycle. (Retifanlimab will be administered following gemcitabine/nab-paclitaxel.)
* 9-ING-41 administered at a dose of 9.3 mg/kg by IV infusion twice weekly on Days 1 and 4 of each week of a 28-day cycle. (9-ING-41 will be administered following retifanlimab.)
9-ING-41: 9-ING-41 is a small molecule potent selective GSK-3β inhibitor
Retifanlimab: Humanized, hinge-stabilized, IgG4κ monoclonal antibody that recognizes human PD-1.
Gemcitabine: cytotoxic chemotherapy agent
Abraxane: cytotoxic chemotherapy agent
|
|---|---|
|
Duration of Response (DOR)
|
5.273 months
Interval 4.862 to 5.684
|
SECONDARY outcome
Timeframe: Up to 12 months (from enrollment)Population: Treated patients evaluable for radiologic response.
Time from study enrollment until objective tumor progression or death. Per RECISIT v1.1, Progressive Disease (PD) is ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Outcome measures
| Measure |
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane
n=6 Participants
* intravenous (IV) infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine according to the gemcitabine label at a dose of 1000 mg per square meter, on days 1, 8, 15 of a 28-day cycle.
* Retifanlimab 500 mg IV on day 1 of a 28-day cycle. (Retifanlimab will be administered following gemcitabine/nab-paclitaxel.)
* 9-ING-41 administered at a dose of 9.3 mg/kg by IV infusion twice weekly on Days 1 and 4 of each week of a 28-day cycle. (9-ING-41 will be administered following retifanlimab.)
9-ING-41: 9-ING-41 is a small molecule potent selective GSK-3β inhibitor
Retifanlimab: Humanized, hinge-stabilized, IgG4κ monoclonal antibody that recognizes human PD-1.
Gemcitabine: cytotoxic chemotherapy agent
Abraxane: cytotoxic chemotherapy agent
|
|---|---|
|
Progression-free Survival (PFS)
|
6.785481 months
Interval 4.970569 to 8.69
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: All study enrolled participants.
Time patients are alive from study enrollment to death from any cause.
Outcome measures
| Measure |
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane
n=7 Participants
* intravenous (IV) infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine according to the gemcitabine label at a dose of 1000 mg per square meter, on days 1, 8, 15 of a 28-day cycle.
* Retifanlimab 500 mg IV on day 1 of a 28-day cycle. (Retifanlimab will be administered following gemcitabine/nab-paclitaxel.)
* 9-ING-41 administered at a dose of 9.3 mg/kg by IV infusion twice weekly on Days 1 and 4 of each week of a 28-day cycle. (9-ING-41 will be administered following retifanlimab.)
9-ING-41: 9-ING-41 is a small molecule potent selective GSK-3β inhibitor
Retifanlimab: Humanized, hinge-stabilized, IgG4κ monoclonal antibody that recognizes human PD-1.
Gemcitabine: cytotoxic chemotherapy agent
Abraxane: cytotoxic chemotherapy agent
|
|---|---|
|
Overall Survival (OS)
|
10.72596 months
Interval 6.965337 to 20.40549
|
Adverse Events
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane
Serious events: 4 serious events
Other events: 7 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane
n=7 participants at risk
* intravenous (IV) infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine according to the gemcitabine label at a dose of 1000 mg per square meter, on days 1, 8, 15 of a 28-day cycle.
* Retifanlimab 500 mg IV on day 1 of a 28-day cycle. (Retifanlimab will be administered following gemcitabine/nab-paclitaxel.)
* 9-ING-41 administered at a dose of 9.3 mg/kg by IV infusion twice weekly on Days 1 and 4 of each week of a 28-day cycle. (9-ING-41 will be administered following retifanlimab.)
9-ING-41: 9-ING-41 is a small molecule potent selective GSK-3β inhibitor
Retifanlimab: Humanized, hinge-stabilized, IgG4κ monoclonal antibody that recognizes human PD-1.
Gemcitabine: cytotoxic chemotherapy agent
Abraxane: cytotoxic chemotherapy agent
|
|---|---|
|
Investigations
Blood bilirubin increased
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Infections and infestations
Sepsis
|
28.6%
2/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Gastrointestinal disorders
Colitis
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Vascular disorders
Thromboembolic event
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
Other adverse events
| Measure |
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane
n=7 participants at risk
* intravenous (IV) infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine according to the gemcitabine label at a dose of 1000 mg per square meter, on days 1, 8, 15 of a 28-day cycle.
* Retifanlimab 500 mg IV on day 1 of a 28-day cycle. (Retifanlimab will be administered following gemcitabine/nab-paclitaxel.)
* 9-ING-41 administered at a dose of 9.3 mg/kg by IV infusion twice weekly on Days 1 and 4 of each week of a 28-day cycle. (9-ING-41 will be administered following retifanlimab.)
9-ING-41: 9-ING-41 is a small molecule potent selective GSK-3β inhibitor
Retifanlimab: Humanized, hinge-stabilized, IgG4κ monoclonal antibody that recognizes human PD-1.
Gemcitabine: cytotoxic chemotherapy agent
Abraxane: cytotoxic chemotherapy agent
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Investigations
Alanine aminotransferase increased
|
42.9%
3/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
28.6%
2/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Blood and lymphatic system disorders
Anemia
|
57.1%
4/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Hepatobiliary disorders
Ascites
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Investigations
Aspartate aminotransferace
|
28.6%
2/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Nervous system disorders
Ataxia
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Nervous system disorders
Bilateral peripheral neuropathy
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Investigations
Blood bilirubin increased
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
71.4%
5/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Vascular disorders
Edema limbs
|
42.9%
3/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
General disorders
Fall
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
General disorders
Fatigue
|
57.1%
4/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Investigations
Febrile neutropenia
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
General disorders
Fever
|
28.6%
2/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
General disorders
Flu like symptoms
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Investigations
Hyperkalemia
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Investigations
Hypokalemia
|
28.6%
2/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Investigations
Hypomagnesemia
|
28.6%
2/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Investigations
Hyponatremia
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Gastrointestinal disorders
Mucositis oral
|
42.9%
3/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
42.9%
3/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Gastrointestinal disorders
Nausea
|
57.1%
4/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Investigations
Neutrophil count decreased
|
57.1%
4/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
General disorders
Non-cardiac chest pain
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
General disorders
Pain in extremity
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Gastrointestinal disorders
Pancreatic fistula
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Skin and subcutaneous tissue disorders
Periorbital Dermatitis
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Investigations
Platelet count decreased
|
42.9%
3/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
42.9%
3/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
28.6%
2/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Nervous system disorders
Syncope
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat pain
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Eye disorders
Transient visual changes- things appearing darker
|
28.6%
2/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Renal and urinary disorders
Urine discoloration
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
General disorders
Weight loss
|
57.1%
4/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Investigations
White blood cell decreased
|
28.6%
2/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysgeusia
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
14.3%
1/7 • Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months
|
Additional Information
Barbara Stadterman, MPH, CCRP, Clinical Research Manager
UPMC Hillman Cancer Center
Phone: 4126475554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place