Clinical trial · Interventional
A Study in Cancer Patients to Evaluate the Effect of a Single Dose of NKTR-102 (Etirinotecan Pegol) on the QTc Interval and to Assess Pharmacokinetics and Safety
A Phase 1 Study to Evaluate the Effect of Nktr-102 for Injection (Etirinotecan Pegol) on the QT/QTC Interval in Patients With Advanced or Metastatic Solid Tumors
NCT01976143CI-TRIAL-00025244completedPhase 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 research study is to evaluate the effect of NKTR-102 on the QT/QTc interval in patients with advanced or metastatic solid tumors
Conditions
Conditions (2)
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 Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NKTR-102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NKTR-102
- description
- A single 90 minute IV infusion of 220 mg/m2 NKTR-102
- interventionNames
- Drug: NKTR-102
Primary outcomes (1)
- measure
- QTcF interval values
- timeFrame
- Day -1 through Day 42
- description
- 10 pre-dose and 18 post-dose ECG measurements to evaluate the effect of NKTR-102
Secondary outcomes (1)
- measure
- Pharmacokinetics (PK) and ECG Parameters
- timeFrame
- Day 1 through Day 42
- description
- 1 pre-dose and 18 post-dose blood samples to measure concentrations of NKTR-102 and its metabolites
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced or metastatic solid tumor refractory to standard therapy * Measurable or non-measurable disease * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Resolution of acute toxic effects of prior chemotherapy and other cancer treatments * Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram * Adequate bone morrow and organ function * Electrolytes within normal limits * Stopped tobacco use for 4 weeks prior to day 1 and during the study * Agree to use adequate contraception Exclusion Criteria: * Previous anti-cancer therapy for malignancy within 4 weeks (6 weeks for the nitrosoureas or mitomycin C) before day 1 * Treatment with antiarrythmic drugs and any medication known to cause QTc prolongation within 4 weeks before screening and during the study * Prior extensive anthracycline exposure * Administration of cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks before day 1 and during the study * Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days prior to day 1 and during the study * History of serious cardiovascular disease * Abnormal systolic blood pressure, diastolic blood pressure and/or heart rate * History of additional risk factors for Torsade de Pointes * Prolonged QTcF * Important abnormalities of the ECG that may interfere with the interpretation of QTc interval changes at screening * Implantable pacemaker or automatic implantable cardioverter defibrillator * 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) * Any major surgery within 4 weeks prior to day 1 * Concurrent treatment with other anticancer therapy * Untreated central nervous system metastases * Chronic or acute GI disorders resulting in diarrhea * Pregnancy or lactation
References
Publications (0)
Data not yet available
No reference posted for this study.