Phase 2 Etirinotecan Pegol in Refractory Brain Metastases & Advanced Lung Cancer / Metastatic Bre… (NCT02312622) | Clinical Trial Compass
CompletedPhase 2
Phase 2 Etirinotecan Pegol in Refractory Brain Metastases & Advanced Lung Cancer / Metastatic Breast Cancer
United States27 participantsStarted 2015-08
Plain-language summary
This phase 2 trial evaluates how well pegylated irinotecan (NKTR-102) works in treating patients with non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), or breast cancer (mBC) that has spread to the brain and does not respond to treatment. Pegylated irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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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 indicated. OR
* Histologically-proven metastatic lung cancer:
* Non-small cell lung cancer (NSCLC) as Stage IV disease or recurrent metastatic disease \[per lung cancer tumor, node and metastasis (TNM) classification system, 7th ed\] (Cohort A) OR
* Small cell lung cancer (SCLC) as extensive stage or recurrent metastatic disease (cohort B), including tumors with mixed small cell and non-small cell elements.
Prior chemotherapy (at least one of the following):
* At least one line of prior systemic chemotherapy
* At least one line of prior targeted treatment for metastatic disease Adjuvant systemic chemotherapy within prior 6 months Prior treatment for metastatic breast cancer (mBC) must have included taxane-based regimen
Prior chemotherapy, including other investigational therapy, has been completed prior to initiation of study treatment, according to the following:
* ≥ 2 weeks if immediately preceding treatment was chemotherapy/targeted therapy administered on a daily or weekly schedule
* ≥ 3 weeks if immediately preceding treatment was chemotherapy/targeted therapy administered every 2 weeks
* ≥ 4 weeks if immediately preceding treatment was chemotherapy/targeted therapy admi…
What they're measuring
1
Central Nervous System (CNS) Disease Control Rate (Cohort A and C)