Clinical trial · Interventional
A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)
An Open-Label, Parallel-Group, Multicenter, Phase 1 Study to Investigate the Pharmacokinetics of NKTR-102 for Injection (Etirinotecan Pegol) in Patients With Advanced or Metastatic Solid Tumors and Hepatic Impairment
NCT01991678CI-TRIAL-00029815completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with mild, moderate, or severe hepatic impairment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 120 mg/m2 NKTR 102 | Drug | — | UNRESOLVED |
| 145 mg/m2 NKTR 102 | Drug | — | UNRESOLVED |
| 50 mg/m2 NKTR 102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- normal hepatic function
- description
- 12 Patients will receive a 90-minute IV infusion
- interventionNames
- Drug: 145 mg/m2 NKTR 102
- type
- EXPERIMENTAL
- label
- mild hepatic dysfunction
- description
- 6 Patients will receive a 90-minute IV infusion
- interventionNames
- Drug: 120 mg/m2 NKTR 102
- type
- EXPERIMENTAL
- label
- severe hepatic dysfunction
- description
- 6 Patients will receive a 90-minute IV infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed or progressive advanced solid tumor malignancies * Measurable or non-measurable disease * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Life expectancy greater than 3 months * Resolution of all acute toxic effects of prior chemotherapy, and other cancer treatments * Adequate bone morrow and kidney function * No signs of decompensated liver cirrhosis or ascites requiring therapeutic paracentesis * Agree to use adequate contraception Exclusion Criteria: * Previous chemotherapy, immunotherapy, chemo-embolization, targeted therapy or investigational agent for malignancy within 4 weeks prior to day 1 * Cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks prior to day 1 * Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days prior to day 1 * UGT1A1 genotype of TA 7 in both alleles (homozygous UGT1A1\*28) or TA 8 in either one or both alleles (hetero- or homozygous for UGT1A1\*37) * Major surgery within 4 weeks prior to day 1 * Undergone a liver or other organ transplant * Concurrent treatment with other anti-cancer therapy * Untreated central nervous system metastases * Ongoing or active infection * Chronic or acute GI disorders resulting in diarrhea * Pregnancy or lactation
References
Publications (0)
Data not yet available
No reference posted for this study.