Trial Outcomes & Findings for Phase II NKTR-102 In Bevacizumab-Resistant High Grade Glioma (NCT NCT01663012)
NCT ID: NCT01663012
Last Updated: 2016-02-24
Results Overview
Will be described using Kaplan-Meier estimates. The PFS probability at 6 weeks (PFS-6week) will be estimated with an 80% power and 95% confidence intervals (80% in accord with the planned alpha level, 95% for comparability with other studies, confidence intervals based on the Greenwood formula for the variance of a survival probability).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
6 weeks from first administration of NKTR-102
Results posted on
2016-02-24
Participant Flow
Participant milestones
| Measure |
Drug: Etirinotecan Pegol
145 mg/m2 dose
Etirinotecan pegol
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II NKTR-102 In Bevacizumab-Resistant High Grade Glioma
Baseline characteristics by cohort
| Measure |
Drug: Etirinotecan Pegol
n=20 Participants
145 mg/m2 dose
Etirinotecan pegol
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
49.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks from first administration of NKTR-102Will be described using Kaplan-Meier estimates. The PFS probability at 6 weeks (PFS-6week) will be estimated with an 80% power and 95% confidence intervals (80% in accord with the planned alpha level, 95% for comparability with other studies, confidence intervals based on the Greenwood formula for the variance of a survival probability).
Outcome measures
| Measure |
Drug: Etirinotecan Pegol
n=20 Participants
145 mg/m2 dose
Etirinotecan pegol
|
|---|---|
|
Progression Free Survival, Assessed by Revised Assessment in Neuro-oncology (RANO) Criteria
|
11 participants
|
SECONDARY outcome
Timeframe: From date of first dose of NKTR-102 to date of death, assessed up to 2 yearsWill be described using Kaplan-Meier estimates.
Outcome measures
| Measure |
Drug: Etirinotecan Pegol
n=20 Participants
145 mg/m2 dose
Etirinotecan pegol
|
|---|---|
|
Survival From the Time of First NKTR-102 Dose for Patients With BEV-resistant Glioma Receiving NKTR-102 to Date of Death
|
4.5 Months
Interval 2.4 to 5.9
|
SECONDARY outcome
Timeframe: From date of pathologic diagnosis/confirmation of high grade glioma to date of death, assessed up to 2 years.Will be described using Kaplan-Meier estimates.
Outcome measures
| Measure |
Drug: Etirinotecan Pegol
n=20 Participants
145 mg/m2 dose
Etirinotecan pegol
|
|---|---|
|
Overall Survival From Time of Diagnosis
|
17.1 Months
Interval 10.0 to 36.6
|
Adverse Events
Drug: Etirinotecan Pegol
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Drug: Etirinotecan Pegol
n=20 participants at risk
145 mg/m2 dose
Etirinotecan pegol
|
|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Metabolism and nutrition disorders
Dehyrdation
|
5.0%
1/20 • Number of events 2 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Metabolism and nutrition disorders
Hyponatermia
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasms, Brain Primary
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Nervous system disorders
Encephalopathy
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Nervous system disorders
Seizure
|
10.0%
2/20 • Number of events 2 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Renal and urinary disorders
Acute Kidney Injury
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
Other adverse events
| Measure |
Drug: Etirinotecan Pegol
n=20 participants at risk
145 mg/m2 dose
Etirinotecan pegol
|
|---|---|
|
Blood and lymphatic system disorders
Neutrophil Count Decreased
|
15.0%
3/20 • Number of events 4 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • Number of events 2 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Eye disorders
Blurred Vision
|
45.0%
9/20 • Number of events 13 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Eye disorders
Dry Eye
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Eye disorders
Eye Twitching
|
10.0%
2/20 • Number of events 2 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Eye disorders
Pressure Behind Eyes
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Gastrointestinal disorders
Abdominal Pain
|
25.0%
5/20 • Number of events 7 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Gastrointestinal disorders
Constipation
|
40.0%
8/20 • Number of events 8 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Gastrointestinal disorders
Diarrhea
|
70.0%
14/20 • Number of events 41 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Gastrointestinal disorders
Fecal Incontinence
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
2/20 • Number of events 3 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
20.0%
4/20 • Number of events 5 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Gastrointestinal disorders
Tongue Swelling
|
10.0%
2/20 • Number of events 2 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Gastrointestinal disorders
Nausea
|
70.0%
14/20 • Number of events 21 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Gastrointestinal disorders
Toothache
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Gastrointestinal disorders
Vomiting
|
45.0%
9/20 • Number of events 9 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
General disorders
Edema Limbs
|
10.0%
2/20 • Number of events 2 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
General disorders
Fatigue
|
60.0%
12/20 • Number of events 18 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
General disorders
Non Cardiac Chest Pain
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
General disorders
Pain
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Infections and infestations
Bladder Infection
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Infections and infestations
Upper Respiratory Infection
|
10.0%
2/20 • Number of events 5 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Number of events 4 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Investigations
Alanine Aminotransferase Increased
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
2/20 • Number of events 2 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
2/20 • Number of events 2 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
30.0%
6/20 • Number of events 7 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
10.0%
2/20 • Number of events 2 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Musculoskeletal and connective tissue disorders
Left Sided Muscle Weakness
|
10.0%
2/20 • Number of events 3 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
10.0%
2/20 • Number of events 3 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Nervous system disorders
Cognative Disturbance
|
10.0%
2/20 • Number of events 3 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Nervous system disorders
Dizziness
|
30.0%
6/20 • Number of events 7 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Nervous system disorders
Dysphasia
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Nervous system disorders
Encephalopathy
|
10.0%
2/20 • Number of events 2 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Nervous system disorders
Headache
|
35.0%
7/20 • Number of events 11 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Nervous system disorders
Seizure
|
40.0%
8/20 • Number of events 11 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Nervous system disorders
Somnolence
|
10.0%
2/20 • Number of events 2 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Psychiatric disorders
Anxiety
|
10.0%
2/20 • Number of events 2 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Psychiatric disorders
Restlessness
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Renal and urinary disorders
Bladder Spasm
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Renal and urinary disorders
Urinary Incontinence
|
10.0%
2/20 • Number of events 2 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Renal and urinary disorders
Urinary Tract Pain
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Number of events 2 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
2/20 • Number of events 2 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.0%
2/20 • Number of events 2 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • Number of events 1 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
|
Vascular disorders
Hypotension
|
10.0%
2/20 • Number of events 2 • Open-ended until 30 days after last dose of Etirinotecan Pegol
|
Additional Information
Lawrence Recht, MD, Professor of Neurology
Stanford University School of Medicine650-
Phone: 650-725-8630
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place