AN OPEN-LABEL, MULTICENTER, EXTENSION STUDY OF NKTR-102 IN SUBJECTS PREVIOUSLY ENROLLED IN NKTR-102 STUDIES

• Register: EUCTR
• Last refreshed on: 22 August 2016
• Main ID: EUCTR2011-002797-23-BE
• Date of registration: 01/07/2011
• Prospective Registration: Yes
• Primary sponsor: Nektar Therapeutics
• Public title: AN OPEN-LABEL, MULTICENTER, EXTENSION STUDY OF NKTR-102 IN SUBJECTS PREVIOUSLY ENROLLED IN NKTR-102 STUDIES
• Scientific title: AN OPEN-LABEL, MULTICENTER, EXTENSION STUDY OF NKTR-102 IN SUBJECTS PREVIOUSLY ENROLLED IN NKTR-102 STUDIES
• Date of first enrolment: 26/07/2011
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002797-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium

Contacts

• Name: Regulatory Affairs
• Affiliation: Aptiv Solutions (UK) Ltd, an ICON plc company

• Name: Regulatory Affairs
• Affiliation: Aptiv Solutions (UK) Ltd, an ICON plc company

Key inclusion & exclusion criteria

Inclusion criteria:
1) Subject or subject's legal representative must provide written informed consent
2) Subject is able and willing to comply with the study visit schedule and procedures
3) Subject must have received prior treatment with NKTR-102 in a Nektar sponsored study
4) Subjects must be without signs of disease progression since receiving NKTR-102
5) Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at the predose visit of each cycle
6) Women of childbearing potential and men who agree to use adequate contraception during study participation (at least two methods of contraception, one of which includes a barrier method [male condom] by the male partner or abstinence) or a male who has undergone a vasectomy greater than 6 months prior to Cycle 1 Day 1. Appropriate contraception must be used for at least 8 months after the last dose of the study drug on this extension study
7) Subjects must meet requirements with respect to hematopoietic function (hemoglobin > 8.0 g/dL or 80 g/dL; absolute neutrophil count (ANC > 1.5 X 109/L; platelets > 75 X 109/L)
8) Subjects must be able to receive the first dose of NKTR-102 in the extension study within 8 weeks after receiving their last dose of NKTR-102
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 75

Exclusion criteria:
1) Subjects who have received intervening anti-cancer therapy (between their last dose of NKTR-102 and administration of the first dose of NKTR-102 in
this extension study)
2) Subjects with 2 dose reductions of NKTR-102 and have a toxicity that requires another dose reduction or who would be scheduled to receive a dose < 70 mg/m2 upon entry into this study
3) Female subjects who are pregnant or lactating, who plan to get pregnant, or
who have a positive pregnancy test at screening or during participation in this study


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Solid tumors
MedDRA version: 17.0 Level: LLT Classification code 10065143 Term: Malignant solid tumour System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: NKTR-102 (etirinotecan pegol)
Product Code: NKTR-102
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Not available
CAS Number: 848779-32-8
Current Sponsor code: NKTR-102
Other descriptive name: etirinotecan pegol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): • Incidence and duration of toxicities, with severity grading according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
• Tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Timepoint(s) of evaluation of this end point: The End-of-Treatment visit is to occur 30 days ± 7 days after last dose of study drug.
Study duration is contingent upon subjects demonstrating continued clinical benefit from treatment with NKTR-102.

Secondary Objective: • To evaluate the safety of continued exposure to NKTR-102
• To observe disease status and survival status in subjects receiving NKTR-102
•To evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors.

Main Objective: • To provide access to NKTR-102 to subjects who previously received NKTR-102 in a clinical trial and are without signs of disease progression since receiving NKTR-102.

Secondary Outcome(s)

Secondary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Secondary ID(s)

11-PIR-09

Source(s) of Monetary Support

Nektar Therapeutics