Phase 2
Completed N=83
NKTR-102 Versus Irinotecan in Patients With Second-Line, Irinotecan-Naïve, KRAS Mutant, Colorectal Cancer
Source: ClinicalTrials.gov NCT00856375 ↗Enrolled (actual)
83
Serious AEs
51.8%
Results posted
Jun 2021
Primary outcomePrimary: Kaplan-Meier Estimate of PFS by Central Radiological Review: ITT Population — 4.0; 2.8 months — p== 0.07
Summary
This study will evaluate whether NKTR-102, an investigational drug has an anti-tumor effect in patients with colorectal cancer. This study will also evaluate how the safety and anti-tumor activity of NKTR-102 compares with irinotecan, a cancer drug that is approved for use in the US for treatment of patients with certain types of colorectal cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan-Meier Estimate of PFS by Central Radiological Review: ITT Population |
4.0; 2.8 | = 0.07 |
| SECONDARY Kaplan-Meier Estimate of OS: ITT Population |
9.6; 8.4 | = 0.706 |
| SECONDARY ORR by Central Radiological Review: ITT Population |
9.8; 5.0 | = 0.676 |
| SECONDARY DoR by Central Radiological Review: ITT Population |
7.9; 1.4 | = 0.018 sig |
| SECONDARY Percentage of Participants (≥2%) With Treatment-Emergent Adverse Events NCI-CTCAE Grade 3 or Higher |
61.9; 63.9; 21.4; 19.5; 7.1; 14.6 | — |
| SECONDARY PK Parameters of NKTR-102 or Irinotecan and Respective Metabolites |
— | — |
Eligibility Criteria
Inclusion Criteria
- metastatic colorectal cancer
- tumor with k-ras mutation
Exclusion Criteria
- More than 1 prior regimen for treatment of metastatic disease
Data sourced from ClinicalTrials.gov (NCT00856375). 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.