E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065143 |
E.1.2 | Term | Malignant solid tumour |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• 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. |
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E.2.2 | Secondary objectives of the trial |
• 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | 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. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |