Trial Outcomes & Findings for QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy (NCT NCT03136406)
NCT ID: NCT03136406
Last Updated: 2024-06-11
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
3 participants
Primary outcome timeframe
30 days after last dose, up to 2 years
Results posted on
2024-06-11
Participant Flow
Participant milestones
| Measure |
NANT Pancreatic Cancer Vaccine
A combination of agents will be administered to subjects in this study:
cyclophosphamide, oxaliplatin, capecitabine, fluorouracil, leucovorin, nab-paclitaxel, bevacizumab, avelumab, ALT-803, aNK, GI-4000, and ETBX-011.
Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
5-Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione
Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt
nab-paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal
avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody
ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex
aNK for Infusion: NK-92 cells
ETBX-011: Ad5 \[E1-, E2b-\]-CEA
GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
NANT Pancreatic Cancer Vaccine
A combination of agents will be administered to subjects in this study:
cyclophosphamide, oxaliplatin, capecitabine, fluorouracil, leucovorin, nab-paclitaxel, bevacizumab, avelumab, ALT-803, aNK, GI-4000, and ETBX-011.
Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
5-Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione
Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt
nab-paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal
avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody
ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex
aNK for Infusion: NK-92 cells
ETBX-011: Ad5 \[E1-, E2b-\]-CEA
GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
|
|---|---|
|
Overall Study
Treatment Discontinued-Investigator Decision
|
3
|
Baseline Characteristics
QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy
Baseline characteristics by cohort
| Measure |
NANT Pancreatic Cancer Vaccine
n=3 Participants
A combination of agents will be administered to subjects in this study:
cyclophosphamide, oxaliplatin, capecitabine, fluorouracil, leucovorin, nab-paclitaxel, bevacizumab, avelumab, ALT-803, aNK, GI-4000, and ETBX-011.
Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
5-Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione
Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt
nab-paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal
avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody
ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex
aNK for Infusion: NK-92 cells
ETBX-011: Ad5 \[E1-, E2b-\]-CEA
GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
|
|---|---|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 14.00 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 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
|
2 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
|
|
Histologically-confirmed pancreatic cancer with progression on or after SoC therapy.
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days after last dose, up to 2 yearsOutcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=3 Participants
A combination of agents will be administered to subjects in this study:
cyclophosphamide, oxaliplatin, capecitabine, fluorouracil, leucovorin, nab-paclitaxel, bevacizumab, avelumab, ALT-803, aNK, GI-4000, and ETBX-011.
Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
5-Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione
Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt
nab-paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal
avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody
ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex
aNK for Infusion: NK-92 cells
ETBX-011: Ad5 \[E1-, E2b-\]-CEA
GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
|
|---|---|
|
Number of Participants With Adverse Events
|
3 Participants
|
Adverse Events
NANT Pancreatic Cancer Vaccine
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
NANT Pancreatic Cancer Vaccine
n=3 participants at risk
A combination of agents will be administered to subjects in this study:
cyclophosphamide, oxaliplatin, capecitabine, fluorouracil, leucovorin, nab-paclitaxel, bevacizumab, avelumab, ALT-803, aNK, GI-4000, and ETBX-011.
Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
5-Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione
Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt
nab-paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal
avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody
ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex
aNK for Infusion: NK-92 cells
ETBX-011: Ad5 \[E1-, E2b-\]-CEA
GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
|
|---|---|
|
General disorders
Injection site erythema
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
Other adverse events
| Measure |
NANT Pancreatic Cancer Vaccine
n=3 participants at risk
A combination of agents will be administered to subjects in this study:
cyclophosphamide, oxaliplatin, capecitabine, fluorouracil, leucovorin, nab-paclitaxel, bevacizumab, avelumab, ALT-803, aNK, GI-4000, and ETBX-011.
Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
5-Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione
Leucovorin: L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt
nab-paclitaxel: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal
avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody
ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex
aNK for Infusion: NK-92 cells
ETBX-011: Ad5 \[E1-, E2b-\]-CEA
GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
3/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
3/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
Injection site erythema
|
100.0%
3/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
Injection site reaction
|
100.0%
3/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
Pyrexia
|
100.0%
3/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
Chills
|
66.7%
2/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
Fatigue
|
66.7%
2/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
Injection site pain
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
Injection site swelling
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
Pain
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
66.7%
2/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Nervous system disorders
Neuropathy peripheral
|
66.7%
2/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
66.7%
2/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Injury, poisoning and procedural complications
Weight decreased
|
66.7%
2/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Metabolism and nutrition disorders
Dehydration
|
66.7%
2/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Investigations
INFUSION-RELATED REACTION - RIGORS
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Gastrointestinal disorders
Oral discomfort
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Metabolism and nutrition disorders
Mucosal inflammation
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place