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Pegylated Irinotecan · 2 trials · 7 indications
Central nervous system (CNS) disease control (DC) is defined as a complete response (CR); partial response (PR); or stable disease (SD). The outcome is reported as the number and percentage of participants who achieve DC, a number without dispersion. Response criteria are as follows. Note that any lesion less than 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs. * CR = Disappearance of all target lesions, sustained for ≥ 4 weeks with no new lesions; clinical condition stable or improved * PR = ≥ 30% decrease in target lesion LD and no new lesions, sustained for ≥ 4 weeks; clinical condition stable or improved * PD (progressive disease) = Any of 20% increase in target lesion LD; increase in T2/FLAIR non-enhancing lesions; any new lesions; non-target progression; or clinical deterioration * SD = Neither PR or PD
The distribution of time to disease progression will be estimated in each group using the method of Kaplan-Meier at 18 weeks.
| Arm | Type | Description |
|---|---|---|
| Cohort A - Pegylated Irinotecan to treat NSCLC | EXPERIMENTAL | Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. |
| Cohort B - Pegylated Irinotecan to treat SCLC | EXPERIMENTAL | Patients with small cell lung carinoma (SCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. |
| Cohort C - Pegylated Irinotecan to treat mBC | EXPERIMENTAL | Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. |
| Treatment (pegylated irinotecan NKTR 102) | EXPERIMENTAL | Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity |
| Name | Type | Description |
|---|---|---|
| Pegylated Irinotecan | DRUG | Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle) |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Pharmacological Study | OTHER | Correlative studies |
Inclusion Criteria: * At least 18 years of age. * Life expectancy of 3 months or longer. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Advanced or refractory cancer, consisting of * Metastatic breast cancer (mBC) for which single-agent cytotoxic chemotherapy is ind...
Pegylated Irinotecan is an investigational oncology drug being studied for recurrent small cell lung carcinoma and stage IV non-small cell lung cancer (NSCLC). It is a small molecule developed by Nektar Therapeutics and has been evaluated in Phase 2 clinical trials for these indications.
Pegylated Irinotecan is a topoisomerase I inhibitor, targeting the enzyme topoisomerase I to disrupt DNA replication in cancer cells. This mechanism is intended to inhibit tumor growth in cancers such as recurrent small cell lung carcinoma and stage IV non-small cell lung cancer.
Pegylated Irinotecan is developed by Nektar Therapeutics, a biopharmaceutical company. The company has conducted clinical trials for this drug in oncology indications, including recurrent small cell lung carcinoma and stage IV non-small cell lung cancer.
Pegylated Irinotecan is in Phase 2 clinical development. It has completed Phase 2 trials for recurrent small cell lung carcinoma and stage IV non-small cell lung cancer, but it is not yet approved by regulatory authorities and remains investigational.
Pegylated Irinotecan has been studied in two completed Phase 2 trials: NCT01876446 for recurrent small cell lung carcinoma and NCT02312622 for stage IV non-small cell lung cancer, recurrent small cell lung cancer, and other advanced cancers. Both trials were conducted in the United States.
Yes, Pegylated Irinotecan is also known as Etirinotecan Pegol. This alternative name appears in clinical trial records, such as NCT02312622, which refers to the drug as Etirinotecan Pegol in its title.