Phase 2
Completed N=27
An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 Studies
Malignant Solid Tumor
Source: ClinicalTrials.gov NCT01457118 ↗
Enrolled (actual)
27
Serious AEs
25.9%
Results posted
Jul 2021
Primary outcomePrimary: Length of Exposure to NKTR-102 — 139.0; 33.0; 126.0; 21.0 days
Summary
The study objective of this open label, multicenter study is to provide access to NKTR-102 treatment to subjects previously enrolled in a NKTR-102 study who are without signs of disease progression since receiving NKTR-102.
In addition the study will evaluate the safety of continued exposure to NKTR-102, observe disease status and survival status in subjects receiving NKTR-102, and evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Exposure to NKTR-102 |
139.0; 33.0; 126.0; 21.0 | — |
| SECONDARY Adverse Events |
3; 1; 0; 0; 3; 0 | — |
| SECONDARY Disease Status |
10; 1; 0; 0; 8; 3 | — |
| SECONDARY Efficacy of NKTR-102 |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion:
- Received prior treatment with NKTR-102
- Free of disease progression since receiving NKTR-102
- Adequate bone marrow and organ function
- Treatment with NKTR-102 in the extension study to begin within 8 weeks after receipt of their of last dose of NKTR-102
- Agree to use adequate contraception
Exclusion:
- Treatment with other anti-cancer therapy between the last dose of NKTR-102 in the prior study and before first dose of NKTR-102 in the extension study
- A toxicity that requires a 3rd dose reduction after taking NKTR-102 or are scheduled to receive a dose < 70 mg/m2 upon entry into this study
- Pregnancy or lactation
Data sourced from ClinicalTrials.gov (NCT01457118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.