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:
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

October 19, 2011
April 30, 2013
October 2011
September 2014   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01457118 on ClinicalTrials.gov Archive Site
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An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies
An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies

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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Expanded Access
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  • Malignant Solid Tumour
  • Breast Cancer
  • Ovarian Cancer
  • Colorectal Cancer
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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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Available
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September 2015
September 2014   (final data collection date for primary outcome measure)

Inclusion:

Subjects must fulfill Inclusion Criteria to be eligible for study entry:

  1. Previous treatment with NKTR-102 with demonstrated clinical benefit
  2. ECOG performance score of 0 or 1
  3. Adequate bone marrow and organ function at screening
  4. Receive the first dose of NKTR-102 int he extension study within 12 weeks of receiving their last dose of the NKTR-102 in the original protocol

Exclusion:

Subjects meeting any of the Exclusion Criteria are ineligible for enrollment:

  1. Received intervening anti-cancer therapy between last dose int he original protocol and administration of the first dose in the extension study
  2. Had major surgery within 4 weeks prior to Day 1 of Cycle 1 or minor surgery within 2 weeks prior to Day 1 Cycle 1.
  3. Received cytochrome P450 #4A(CYP3A4)inducers or inhibitors
  4. Receiving anti-cancer biologic agents with 28 days of Day 1 Cycle 1
  5. Have unresolved or irreversible NKTR-102 related ongoing AE occurring during the original protocol
  6. Have diarrhea.
Both
18 Years and older
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Contact: Robert Medve, MD 415-482-5300 RMedve@nektar.com
Contact: Charleen Jue, BS 415-482-5300 cjue@nektar.com
United States,   Belgium
 
NCT01457118
11-PIR-09
Yes
Nektar Therapeutics
Nektar Therapeutics
Not Provided
Study Director: Robert Medve, MD Nektar Therapeutics
Nektar Therapeutics
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP