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Phase II NKTR-102 In Bevacizumab-Resistant High Grade Glioma

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ClinicalTrials.gov Identifier: NCT01663012
Recruitment Status : Completed
First Posted : August 13, 2012
Results First Posted : June 11, 2015
Last Update Posted : February 24, 2016
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Lawrence Recht, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Anaplastic Astrocytomas
Anaplastic Oligodendrogliomas
Glioblastomas (GBM)
Intervention Drug: Etirinotecan pegol
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Drug: Etirinotecan Pegol
Hide Arm/Group Description

145 mg/m2 dose

Etirinotecan pegol

Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Drug: Etirinotecan Pegol
Hide Arm/Group Description

145 mg/m2 dose

Etirinotecan pegol

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  85.0%
>=65 years
3
  15.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
49.5
(20 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
8
  40.0%
Male
12
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
1
   5.0%
Not Hispanic or Latino
19
  95.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
  15.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
16
  80.0%
More than one race
1
   5.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Progression Free Survival, Assessed by Revised Assessment in Neuro-oncology (RANO) Criteria
Hide Description 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).
Time Frame 6 weeks from first administration of NKTR-102
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drug: Etirinotecan Pegol
Hide Arm/Group Description:

145 mg/m2 dose

Etirinotecan pegol

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
11
2.Secondary Outcome
Title Survival From the Time of First NKTR-102 Dose for Patients With BEV-resistant Glioma Receiving NKTR-102 to Date of Death
Hide Description Will be described using Kaplan-Meier estimates.
Time Frame From date of first dose of NKTR-102 to date of death, assessed up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drug: Etirinotecan Pegol
Hide Arm/Group Description:

145 mg/m2 dose

Etirinotecan pegol

Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: Months
4.5
(2.4 to 5.9)
3.Secondary Outcome
Title Overall Survival From Time of Diagnosis
Hide Description Will be described using Kaplan-Meier estimates.
Time Frame From date of pathologic diagnosis/confirmation of high grade glioma to date of death, assessed up to 2 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drug: Etirinotecan Pegol
Hide Arm/Group Description:

145 mg/m2 dose

Etirinotecan pegol

Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: Months
17.1
(10.0 to 36.6)
Time Frame Open-ended until 30 days after last dose of Etirinotecan Pegol
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Drug: Etirinotecan Pegol
Hide Arm/Group Description

145 mg/m2 dose

Etirinotecan pegol

All-Cause Mortality
Drug: Etirinotecan Pegol
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Drug: Etirinotecan Pegol
Affected / at Risk (%) # Events
Total   5/20 (25.00%)    
Blood and lymphatic system disorders   
Pancytopenia  1  1/20 (5.00%)  1
Gastrointestinal disorders   
Diarrhea  1  1/20 (5.00%)  1
Metabolism and nutrition disorders   
Dehyrdation  1  1/20 (5.00%)  2
Hyponatermia  1  1/20 (5.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Malignant Neoplasms, Brain Primary  1  1/20 (5.00%)  1
Nervous system disorders   
Encephalopathy  1  1/20 (5.00%)  1
Seizure  1  2/20 (10.00%)  2
Renal and urinary disorders   
Acute Kidney Injury  1  1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory Failure  1  1/20 (5.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Drug: Etirinotecan Pegol
Affected / at Risk (%) # Events
Total   20/20 (100.00%)    
Blood and lymphatic system disorders   
Neutrophil Count Decreased  1  3/20 (15.00%)  4
Cardiac disorders   
Palpitations  1  1/20 (5.00%)  2
Eye disorders   
Blurred Vision  1  9/20 (45.00%)  13
Dry Eye  1  1/20 (5.00%)  1
Eye Twitching  1  2/20 (10.00%)  2
Pressure Behind Eyes  1  1/20 (5.00%)  1
Gastrointestinal disorders   
Abdominal Pain  1  5/20 (25.00%)  7
Constipation  1  8/20 (40.00%)  8
Diarrhea  1  14/20 (70.00%)  41
Fecal Incontinence  1  1/20 (5.00%)  1
Flatulence  1  2/20 (10.00%)  3
Gastroesophageal Reflux Disease  1  4/20 (20.00%)  5
Tongue Swelling  1  2/20 (10.00%)  2
Nausea  1  14/20 (70.00%)  21
Toothache  1  1/20 (5.00%)  1
Vomiting  1  9/20 (45.00%)  9
General disorders   
Edema Limbs  1  2/20 (10.00%)  2
Fatigue  1  12/20 (60.00%)  18
Non Cardiac Chest Pain  1  1/20 (5.00%)  1
Pain  1  1/20 (5.00%)  1
Infections and infestations   
Bladder Infection  1  1/20 (5.00%)  1
Upper Respiratory Infection  1  2/20 (10.00%)  5
Injury, poisoning and procedural complications   
Fall  1  1/20 (5.00%)  4
Investigations   
Alanine Aminotransferase Increased  1  1/20 (5.00%)  1
Metabolism and nutrition disorders   
Hypokalemia  1  2/20 (10.00%)  2
Anorexia  1  1/20 (5.00%)  1
Hyponatremia  1  2/20 (10.00%)  2
Dehydration  1  1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal Pain  1  6/20 (30.00%)  7
Generalized Muscle Weakness  1  2/20 (10.00%)  2
Left Sided Muscle Weakness  1  2/20 (10.00%)  3
Muscle Weakness Lower Limb  1  2/20 (10.00%)  3
Nervous system disorders   
Cognative Disturbance  1  2/20 (10.00%)  3
Dizziness  1  6/20 (30.00%)  7
Dysphasia  1  1/20 (5.00%)  1
Encephalopathy  1  2/20 (10.00%)  2
Headache  1  7/20 (35.00%)  11
Peripheral Motor Neuropathy  1  1/20 (5.00%)  1
Seizure  1  8/20 (40.00%)  11
Somnolence  1  2/20 (10.00%)  2
Psychiatric disorders   
Anxiety  1  2/20 (10.00%)  2
Depression  1  1/20 (5.00%)  1
Restlessness  1  1/20 (5.00%)  1
Renal and urinary disorders   
Bladder Spasm  1  1/20 (5.00%)  1
Urinary Incontinence  1  2/20 (10.00%)  2
Urinary Tract Pain  1  1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/20 (10.00%)  2
Dyspnea  1  1/20 (5.00%)  1
Epistaxis  1  2/20 (10.00%)  2
Hiccups  1  2/20 (10.00%)  2
Skin and subcutaneous tissue disorders   
Alopecia  1  1/20 (5.00%)  1
Vascular disorders   
Hypotension  1  2/20 (10.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Lawrence Recht, MD, Professor of Neurology
Organization: Stanford University School of Medicine650-
Phone: 650-725-8630
Responsible Party: Lawrence Recht, Stanford University
ClinicalTrials.gov Identifier: NCT01663012     History of Changes
Other Study ID Numbers: IRB-24833
SU-06212012-10228 ( Other Identifier: Stanford University )
NCI-2012-01288 ( Other Identifier: National Cancer Institute )
BRN0021 ( Other Identifier: OnCore )
First Submitted: August 2, 2012
First Posted: August 13, 2012
Results First Submitted: May 28, 2015
Results First Posted: June 11, 2015
Last Update Posted: February 24, 2016