An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies
Expanded access is currently available for this treatment.
Verified April 2013 by Nektar Therapeutics
Sponsor:
Nektar Therapeutics
Information provided by (Responsible Party):
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT01457118
First received: October 19, 2011
Last updated: April 30, 2013
Last verified: April 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 19, 2011 | ||||||||
| Last Updated Date | April 30, 2013 | ||||||||
| Start Date ICMJE | October 2011 | ||||||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01457118 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies | ||||||||
| Official Title ICMJE | An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies | ||||||||
| Brief Summary | The study objective of this open label, multicenter study is to provide access to NKTR-102 treatment to subjects previously enrolled in NKTR-102 studies and to evaluate the safety of long-term exposure to NKTR-102. In additional the study will track disease progression and survival status in subjects who have ongoing clinical benefit from continued treatment with NKTR-102. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Expanded Access | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Not Provided | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: NKTR-102
Dose will carry forward from original NKTR-102, IV administration of NKTR-102 will occur on Day 1 of each cycle. Cycle length will be determined by schedule used in original NKTR-102 study. |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Available | ||||||||
| Enrollment ICMJE | Not Provided | ||||||||
| Estimated Completion Date | September 2015 | ||||||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion: Subjects must fulfill Inclusion Criteria to be eligible for study entry:
Exclusion: Subjects meeting any of the Exclusion Criteria are ineligible for enrollment:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, Belgium | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01457118 | ||||||||
| Other Study ID Numbers ICMJE | 11-PIR-09 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Nektar Therapeutics | ||||||||
| Study Sponsor ICMJE | Nektar Therapeutics | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Nektar Therapeutics | ||||||||
| Verification Date | April 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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