Clinical Trial Results:
An Open-label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies
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Summary
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EudraCT number |
2011-002797-23 |
Trial protocol |
BE |
Global end of trial date |
23 Aug 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Dec 2018
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First version publication date |
19 Dec 2018
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
11-PIR-09
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01457118 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Nektar Therapeutics
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Sponsor organisation address |
455 Mission Bay Boulevard South, San Francisco, CA, United States, 94158
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Public contact |
Nektar Therapeutics, Nektar Therapeutics, 001 855-482-8676, studyinquiry@nektar.com
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Scientific contact |
Nektar Therapeutics, Nektar Therapeutics, 001 855-482-8676, studyinquiry@nektar.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
23 Aug 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Aug 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To provide access to NKTR-102 treatment to subjects previously enrolled in a NKTR-102 study, who were without signs of disease progression since receiving NKTR-102. The study evaluated the safety of continued exposure to NKTR-102, observed disease and survival status and evaluated the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumours.
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Protection of trial subjects |
All study subjects were required to read and sign an Informed Consent Form
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Sep 2011
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety | ||
Long term follow-up duration |
4 Years | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Korea, Republic of: 1
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Country: Number of subjects enrolled |
United States: 24
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Country: Number of subjects enrolled |
Belgium: 2
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Worldwide total number of subjects |
27
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EEA total number of subjects |
2
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
22
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From 65 to 84 years |
5
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were enrolled at 8 study sites in 3 countries. | ||||||||||||||||
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Pre-assignment
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Screening details |
Subjects, who previously received NKTR-102 in a clinical trial and were without signs of disease progression since receiving NKTR-102, were enrolled in this study. Subjects were to receive repeated cycles of NKTR-102 as long as there was evidence of disease control in the judgment of the Investigator. | ||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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NKTR-102 | ||||||||||||||||
Arm description |
Subjects received NKTR-102 on Day 1 of each 21-day treatment cycle. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
NKTR-102
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Investigational medicinal product code |
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Other name |
etirinotecan pegol
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Pharmaceutical forms |
Powder for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
A 90-minute intravenous (IV) infusion of NKTR-102 on Day 1 of each 21-day treatment cycle.
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Baseline characteristics reporting groups
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Reporting group title |
NKTR-102
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Reporting group description |
Subjects received NKTR-102 on Day 1 of each 21-day treatment cycle. | |||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
NKTR-102
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Reporting group description |
Subjects received NKTR-102 on Day 1 of each 21-day treatment cycle. | ||
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End point title |
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [1] | ||||||||||||
End point description |
An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAE was any event not present before exposure to the study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug. A serious adverse event is any event that fulfilled at least one of the following criteria: fatal, life-threatening, required in-patient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Safety Population included all subjects who received at least one dose of study treatment.
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End point type |
Primary
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End point timeframe |
From baseline up to approximately 5 years and 11 months
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data were planned to be reported for the endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Best Overall Response Rate by Investigator | ||||||||
End point description |
Data on best overall response for complete response (CR) or partial response (PR) were collected as determined by the investigator according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1). Tumour measurements were not required; only an overall assessment of response or progression by the Investigator was required. CR: disappearance of all target lesions. PR: At least a 30% decrease in all target lesions. The best overall response rate was calculated as number of subjects with response/number of subjects who had measurable lesions. Safety Population included all subjects who received at least one dose of study treatment. Overall number of subjects analysed is the number of subjects with data available for analysis at the given time-point.
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End point type |
Secondary
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End point timeframe |
From baseline up to approximately 5 years and 11 months
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From baseline up to approximately 5 years and 11 months
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Adverse event reporting additional description |
Safety Population included all subjects who received at least one dose of study treatment.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.0
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Reporting groups
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Reporting group title |
NKTR-102
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Reporting group description |
Subjects received NKTR-102 on Day 1 of each 21-day treatment cycle. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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07 May 2013 |
The protocol was modified to enable enrolment of subjects from varied study designs. Clarified that a subject may receive treatment for approximately 2 years, but the study could last about 5 years due to follow-up for survival status after treatment with NKTR-102 stops. The section on dose modifications and delays was updated to accommodate doses other than 145 mg/m^2. Updated sections on adverse events to properly describe the reporting of AEs that could occur to subjects during the transition from their original protocol to this extension study. Updated the description of use of anti-diarrhoeal therapy to include the most current advice regarding prophylactic use of atropine for cholinergic symptoms and recommend the use of loperamide to treat diarrhoea. Incorporated a section on use of growth factor support and transfusions to describe their allowable use in greater detail. Updated the permitted and prohibited treatments to include more detail and provide current requirements. Updated text regarding pregnancy and use of adequate birth control. Provided a more comprehensive list of CYP3A4 inhibitors and inducers that are prohibited during the study. |
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25 Sep 2013 |
Included a study objective and endpoint to evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumours. Added Eastern Cooperative Oncology Group (ECOG) performance status at Screening and each treatment visit, and added physical examination, vital signs, and ECOG performance status assessments to the End-of-Treatment visit. |
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14 Jan 2016 |
Added +/- 4 week window to the long-term follow-up visit schedule. Updated the exclusion criterion which stated that subjects who would be scheduled to receive a dose < 70 mg/m^2 would be excluded, to allow subjects with moderate or severe hepatic impairment (treated with a dose of 50 mg/m^2). Clarified the method for calculating body surface area (BSA): to be determined before the start of each cycle, based on baseline height and most recent weight. Included dose reduction guidelines for subjects entering the study at a starting dose of 50 mg/m^2. Included additional recommendations for NKTR-102 dose modifications following toxicities. Updated advisements on late-onset diarrhoea to align with information in other clinical study protocols currently using NKTR-102. Removed dose schedule from analysis of maximum intensity and frequency of AEs: AEs summarized by treatment (dose level). |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
