Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
Metastatic Solid Tumors, Locally Advanced Solid Tumors
Brief summary
This is a first in human, open-label, sequential dose escalation and expansion Phase 1 study of NKTR-214 in adult patients with locally advanced or metastatic solid tumors.
Interventions
DRUGNKTR-214
Participants in the dose escalation cohorts will be treated every 21 days (q21d) or every 14 days (q14d) until tumor progression.
Sponsors
Nektar Therapeutics
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor. * Received 1 or 2 prior lines of therapy. * Life expectancy \>12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. * Measurable disease per RECIST v1.1. * Demonstrated adequate organ function within 14 days of treatment initiation. * Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior system anticancer therapy, radiotherapy or surgery. * Women of childbearing potential must agree to use highly effective methods of birth control. * All participants must agree to use double barrier contraception during study participation and for at least 2 months after the last dose of study drug. * Additional criteria may apply.
Exclusion criteria
* Use of an investigational agent or an investigational device within 28 days before administration of first dose of NKTR-214. * Females who are pregnant or breastfeeding. * Participants who have an active autoimmune disease requiring systemic treatment within the past 3 months or have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents. * Active central nervous system (CNS) metastases. * Prior surgery or radiotherapy within 14 days of therapy. * Participants who have had \< 28 days since the last chemotherapy, immunotherapy, biological therapy, or \< 14 days from approved tyrosine kinase inhibitor (TKI) therapy (sunitinib, sorafenib, vemurafenib, dabrafenib, cobimetinib), or systemic or inhaled steroid therapy at doses greater than 10mg of prednisone or equivalent before administration of the first dose of study medication. * Participants' inability to adhere to or tolerate protocol or study procedures. * Additional criteria may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | 30 days after last dose, approximately 533 days | This outcome quantifies the number and types of adverse events associated with NKTR-214. |
| Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) | 30 days after last dose, up to 533 days | The data below reflects the incidence of Dose Limiting Toxicity Events observed in this trial. |
Countries
United States
Participant flow
Pre-assignment details
The Sponsor discontinued enrollment in order to allow the clinical development program for NKTR-214 to continue with other studies in which NKTR-214 was administered in combination with checkpoint inhibitors, based on biomarker analysis, which showed infiltration of immune cells within tumor tissue.
Participants by arm
| Arm | Count |
|---|---|
| NKTR-214 0.003 mg/kg q21d NKTR-214 given at a dose of 0.003 mg/kg every 21 days | 4 |
| NKTR-214 0.006 mg/kg q21d NKTR-214 given at a dose of 0.006 mg/kg every 21 days | 11 |
| NKTR-214 0.006 mg/kg q14d NKTR-214 given at a dose of 0.006 mg/kg every 14 days | 6 |
| NKTR-214 0.009 mg/kg q21d NKTR-214 given at a dose of 0.009 mg/kg every 21 days | 6 |
| NKTR-214 0.012 mg/kg q21d NKTR-214 given at a dose of 0.012 mg/kg every 21 days | 1 |
| Total | 28 |
Baseline characteristics
| Characteristic | Total | NKTR-214 0.003 mg/kg q21d | NKTR-214 0.012 mg/kg q21d | NKTR-214 0.006 mg/kg q21d | NKTR-214 0.009 mg/kg q21d | NKTR-214 0.006 mg/kg q14d |
|---|---|---|---|---|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 10.58 | 54.8 years STANDARD_DEVIATION 14.17 | 43.0 years | 56.5 years STANDARD_DEVIATION 11.59 | 60.8 years STANDARD_DEVIATION 5 | 62.0 years STANDARD_DEVIATION 10.16 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status, n(%) 0 | 16 Participants | 3 Participants | 1 Participants | 7 Participants | 3 Participants | 2 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status, n(%) 1 | 12 Participants | 1 Participants | 0 Participants | 4 Participants | 3 Participants | 4 Participants |
| Lines of Prior Systemic Cancer Therapy | 2.9 number of lines of therapy STANDARD_DEVIATION 2.59 | 5.3 number of lines of therapy STANDARD_DEVIATION 4.72 | 1 number of lines of therapy | 1.8 number of lines of therapy STANDARD_DEVIATION 1.25 | 3.3 number of lines of therapy STANDARD_DEVIATION 2.34 | 3.0 number of lines of therapy STANDARD_DEVIATION 2.53 |
| Prior Therapies # of Participants with previous Chemotherapy | 10 participants | 3 participants | 0 participants | 2 participants | 1 participants | 4 participants |
| Prior Therapies # of Participants with previous ICI and other immunotherapy | 6 participants | 1 participants | 0 participants | 1 participants | 4 participants | 0 participants |
| Prior Therapies # of Participants with previous Immune Checkpoint Inhibitor (ICI) Only | 16 participants | 3 participants | 1 participants | 4 participants | 6 participants | 2 participants |
| Prior Therapies # of Participants with previous Targeted Therapy | 14 participants | 3 participants | 0 participants | 8 participants | 3 participants | 2 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 4 Participants | 1 Participants | 8 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Female | 11 Participants | 1 Participants | 0 Participants | 6 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 17 Participants | 3 Participants | 1 Participants | 5 Participants | 4 Participants | 4 Participants |
| Status Enrollment Locally Recurrent | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Status Enrollment Metastatic | 26 Participants | 4 Participants | 1 Participants | 9 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 4 | 3 / 11 | 2 / 6 | 1 / 6 | 0 / 1 |
| other Total, other adverse events | 4 / 4 | 11 / 11 | 6 / 6 | 6 / 6 | 1 / 1 |
| serious Total, serious adverse events | 2 / 4 | 5 / 11 | 4 / 6 | 3 / 6 | 1 / 1 |
Outcome results
Primary
Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs)
This outcome quantifies the number and types of adverse events associated with NKTR-214.
Time frame: 30 days after last dose, approximately 533 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dyspepsia Grade 1-2 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Gastroduodenal Hemorrhage Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Generalized edema Grade 1-2 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Decreased Appetite Grade 1-2 | 1 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hemiparesis Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Anemia Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pruritus Grade 1-2 | 2 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hypovolemic Shock Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Flu-Like Symptoms Grade 1-2 | 3 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Lipase Increased Grade 3-5 | 1 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Fatigue Grade 1-2 | 3 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Liver Function Test Abnormal Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Sepsis Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Lower Gastrointestinal Hemorrhage Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Metastases to Meninges Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Metastases to Central Nervous System Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dry Skin Grade 1-2 | 1 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Constipation Grade 1-2 | 2 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Cytokine Release Syndrome Grade 1-2 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Constipation Grade 3-5 | 1 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pain Extremity Grade 1-2 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Blood creatine increased Grade 1-2 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Peripheral Edema Grade 1-2 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Headache Grade 1-2 | 3 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Event of Anxiety Grade 1-2 | 1 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Peripheral Edema Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Flushing Grade 1-2 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Abdominal Pain Grade 1-2 | 1 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Weight Decreased Grade 1-2 | 2 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Abdominal pain Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Vomiting Grade 1-2 | 1 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pleural Effusion Grade 1-2 | 1 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Oropharyngeal Pain Grade 1-2 | 1 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Myalgia Grade 1-2 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pleural Effusion Grade 3-5 | 1 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Headache Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dizziness Grade 1-2 | 2 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Confusional State Grade 1-2 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Nasal Congestion Grade 1-2 | 1 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Confusional State Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hypotension Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dyspnea Grade 1-2 | 3 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Infusion Related Reaction Grade 1-2 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Diarrhea Grade 1-2 | 3 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Infusion Related Reaction Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Muscular Weakness Grade 1-2 | 1 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Nausea Grade 1-2 | 3 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Presyncope Grade 1-2 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Anemia Grade 1-2 | 2 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Cough Grade 1-2 | 1 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Presyncope Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Arthralgia Grade 1-2 | 1 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Brain Edema Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Syncope Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hypotension Grade 1-2 | 2 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Disease Progression Grade 3-5 | 0 events |
| NKTR-214 0.003 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Rash Grade 1-2 | 3 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hypotension Grade 3-5 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Weight Decreased Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Gastroduodenal Hemorrhage Grade 3-5 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Brain Edema Grade 3-5 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Infusion Related Reaction Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pruritus Grade 1-2 | 7 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Abdominal pain Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hemiparesis Grade 3-5 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Oropharyngeal Pain Grade 1-2 | 2 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Vomiting Grade 1-2 | 2 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Flu-Like Symptoms Grade 1-2 | 8 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Muscular Weakness Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hypovolemic Shock Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Anemia Grade 3-5 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Diarrhea Grade 1-2 | 2 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Fatigue Grade 1-2 | 9 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pleural Effusion Grade 1-2 | 2 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Lipase Increased Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Syncope Grade 3-5 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Generalized edema Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Sepsis Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Myalgia Grade 1-2 | 3 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Liver Function Test Abnormal Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dyspepsia Grade 1-2 | 0 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Presyncope Grade 3-5 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Metastases to Meninges Grade 3-5 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Infusion Related Reaction Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Lower Gastrointestinal Hemorrhage Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Decreased Appetite Grade 1-2 | 6 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pleural Effusion Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Anemia Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Metastases to Central Nervous System Grade 3-5 | 2 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hypotension Grade 1-2 | 8 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dry Skin Grade 1-2 | 2 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dizziness Grade 1-2 | 3 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Nausea Grade 1-2 | 3 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Constipation Grade 1-2 | 3 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pain Extremity Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Cytokine Release Syndrome Grade 1-2 | 0 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Arthralgia Grade 1-2 | 3 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Confusional State Grade 1-2 | 0 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Constipation Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Headache Grade 3-5 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Blood creatine increased Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Nasal Congestion Grade 1-2 | 2 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Disease Progression Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Peripheral Edema Grade 1-2 | 4 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Presyncope Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Event of Anxiety Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Confusional State Grade 3-5 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Rash Grade 1-2 | 6 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Peripheral Edema Grade 3-5 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Headache Grade 1-2 | 2 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Flushing Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dyspnea Grade 1-2 | 4 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Cough Grade 1-2 | 5 events |
| NKTR-214 0.006 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Abdominal Pain Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Rash Grade 1-2 | 4 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hypotension Grade 1-2 | 2 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Syncope Grade 3-5 | 1 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Headache Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Headache Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Anemia Grade 1-2 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Anemia Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Metastases to Central Nervous System Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Constipation Grade 1-2 | 2 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Constipation Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Peripheral Edema Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Peripheral Edema Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Abdominal Pain Grade 1-2 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Abdominal pain Grade 3-5 | 2 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pleural Effusion Grade 1-2 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pleural Effusion Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Confusional State Grade 1-2 | 2 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Confusional State Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Infusion Related Reaction Grade 1-2 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Infusion Related Reaction Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Presyncope Grade 1-2 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Presyncope Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Brain Edema Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Disease Progression Grade 3-5 | 1 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Gastroduodenal Hemorrhage Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hemiparesis Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hypovolemic Shock Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Lipase Increased Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Liver Function Test Abnormal Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Lower Gastrointestinal Hemorrhage Grade 3-5 | 1 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Metastases to Meninges Grade 3-5 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Sepsis Grade 3-5 | 1 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Fatigue Grade 1-2 | 5 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Flu-Like Symptoms Grade 1-2 | 4 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pruritus Grade 1-2 | 5 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Decreased Appetite Grade 1-2 | 4 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Arthralgia Grade 1-2 | 5 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Cough Grade 1-2 | 2 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Nausea Grade 1-2 | 3 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Diarrhea Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dyspnea Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Nasal Congestion Grade 1-2 | 2 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dizziness Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Myalgia Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Vomiting Grade 1-2 | 2 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Weight Decreased Grade 1-2 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Flushing Grade 1-2 | 2 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Event of Anxiety Grade 1-2 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Blood creatine increased Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Cytokine Release Syndrome Grade 1-2 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dry Skin Grade 1-2 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dyspepsia Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Generalized edema Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Muscular Weakness Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Oropharyngeal Pain Grade 1-2 | 0 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pain Extremity Grade 1-2 | 1 events |
| NKTR-214 0.006 mg/kg q14d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hypotension Grade 3-5 | 2 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Anemia Grade 3-5 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Generalized edema Grade 1-2 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Decreased Appetite Grade 1-2 | 4 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Disease Progression Grade 3-5 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Brain Edema Grade 3-5 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Rash Grade 1-2 | 2 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Presyncope Grade 3-5 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Arthralgia Grade 1-2 | 2 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Presyncope Grade 1-2 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Cough Grade 1-2 | 3 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Infusion Related Reaction Grade 3-5 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Headache Grade 3-5 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Nausea Grade 1-2 | 2 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Infusion Related Reaction Grade 1-2 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hypotension Grade 1-2 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Diarrhea Grade 1-2 | 3 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Confusional State Grade 3-5 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Muscular Weakness Grade 1-2 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dyspnea Grade 1-2 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Confusional State Grade 1-2 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Nasal Congestion Grade 1-2 | 3 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pleural Effusion Grade 3-5 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dizziness Grade 1-2 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pleural Effusion Grade 1-2 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Headache Grade 1-2 | 2 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Myalgia Grade 1-2 | 2 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Abdominal pain Grade 3-5 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Vomiting Grade 1-2 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Abdominal Pain Grade 1-2 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Oropharyngeal Pain Grade 1-2 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Weight Decreased Grade 1-2 | 2 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Peripheral Edema Grade 3-5 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Flushing Grade 1-2 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Peripheral Edema Grade 1-2 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Event of Anxiety Grade 1-2 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Constipation Grade 3-5 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Syncope Grade 3-5 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Blood creatine increased Grade 1-2 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Constipation Grade 1-2 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hypotension Grade 3-5 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Cytokine Release Syndrome Grade 1-2 | 2 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Metastases to Central Nervous System Grade 3-5 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pain Extremity Grade 1-2 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dry Skin Grade 1-2 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Lower Gastrointestinal Hemorrhage Grade 3-5 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dyspepsia Grade 1-2 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Metastases to Meninges Grade 3-5 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Liver Function Test Abnormal Grade 3-5 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Sepsis Grade 3-5 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Lipase Increased Grade 3-5 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Fatigue Grade 1-2 | 5 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hypovolemic Shock Grade 3-5 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Anemia Grade 1-2 | 1 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Flu-Like Symptoms Grade 1-2 | 5 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hemiparesis Grade 3-5 | 0 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pruritus Grade 1-2 | 4 events |
| NKTR-214 0.009 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Gastroduodenal Hemorrhage Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Lower Gastrointestinal Hemorrhage Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Weight Decreased Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Peripheral Edema Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Decreased Appetite Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Flu-Like Symptoms Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Brain Edema Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Oropharyngeal Pain Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Liver Function Test Abnormal Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Rash Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Presyncope Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Flushing Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Generalized edema Grade 1-2 | 1 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Peripheral Edema Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Arthralgia Grade 1-2 | 1 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Presyncope Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Fatigue Grade 1-2 | 1 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Headache Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Syncope Grade 3-5 | 1 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Cough Grade 1-2 | 1 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Infusion Related Reaction Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pruritus Grade 1-2 | 1 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Event of Anxiety Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Constipation Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Nausea Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Infusion Related Reaction Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Metastases to Meninges Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hemiparesis Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Lipase Increased Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Diarrhea Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Confusional State Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Blood creatine increased Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Constipation Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dyspepsia Grade 1-2 | 1 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dyspnea Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Confusional State Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Gastroduodenal Hemorrhage Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Muscular Weakness Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Sepsis Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Nasal Congestion Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pleural Effusion Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Cytokine Release Syndrome Grade 1-2 | 1 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Headache Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Metastases to Central Nervous System Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dizziness Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pleural Effusion Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hypotension Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hypovolemic Shock Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Anemia Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Myalgia Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Abdominal pain Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Dry Skin Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Hypotension Grade 3-5 | 1 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Anemia Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Vomiting Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Abdominal Pain Grade 1-2 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Disease Progression Grade 3-5 | 0 events |
| NKTR-214 0.012 mg/kg q21d | Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) | # of Events of Pain Extremity Grade 1-2 | 0 events |
Primary
Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs)
The data below reflects the incidence of Dose Limiting Toxicity Events observed in this trial.
Time frame: 30 days after last dose, up to 533 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NKTR-214 0.003 mg/kg q21d | Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) | # of Events of Grade 3 Hypotension | 0 events |
| NKTR-214 0.003 mg/kg q21d | Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) | # of Events of Grade 3 Syncope | 0 events |
| NKTR-214 0.006 mg/kg q21d | Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) | # of Events of Grade 3 Hypotension | 0 events |
| NKTR-214 0.006 mg/kg q21d | Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) | # of Events of Grade 3 Syncope | 0 events |
| NKTR-214 0.006 mg/kg q14d | Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) | # of Events of Grade 3 Hypotension | 0 events |
| NKTR-214 0.006 mg/kg q14d | Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) | # of Events of Grade 3 Syncope | 0 events |
| NKTR-214 0.009 mg/kg q21d | Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) | # of Events of Grade 3 Syncope | 0 events |
| NKTR-214 0.009 mg/kg q21d | Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) | # of Events of Grade 3 Hypotension | 0 events |
| NKTR-214 0.012 mg/kg q21d | Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) | # of Events of Grade 3 Hypotension | 1 events |
| NKTR-214 0.012 mg/kg q21d | Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) | # of Events of Grade 3 Syncope | 1 events |