Phase II Etirinotecan Pegol in Refractory Brain Metastases & Advanced Lung Cancer / Metastatic Breast Cancer
|Extensive Stage Small Cell Lung Cancer Recurrent Non-small Cell Lung Cancer Recurrent Small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer Tumors Metastatic to Brain Metastatic Breast Cancer||Drug: pegylated irinotecan NKTR 102 Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Etirinotecan Pegol (NKTR 102) in Patients With Refractory Brain Metastases and Advanced Lung Cancer or Metastatic Breast Cancer (MBC)|
- CNS disease control rate (number of patients with stable disease + partial response + complete response divided by the total number of evaluable patients) (Cohort A and C) [ Time Frame: At 12 weeks ]The proportion, its 95% confidence interval using the Exact method, and p value of rejection the null hypothesis (5%) will be summarized.
- Overall disease control rate (Cohort A and C) [ Time Frame: At 12 weeks ]
- Overall response rate (Cohort A and C) [ Time Frame: At 12 weeks ]
- Systemic (non-CNS) disease control rate (Cohort A and C) [ Time Frame: At 12 weeks ]
- Systemic (non-CNS) response rate (Cohort A and C) [ Time Frame: At 12 weeks ]
- Progression-free survival (PFS) (Cohort A and C) [ Time Frame: Date of first dose of pegylated irinotecan NKTR 102 to date of disease progression, assessed up to 2 years ]Will be described using Kaplan Meier estimates. The PFS probability at 12 weeks will be estimated with an 80% power and 95% confidence intervals (80% in accord with the planned alpha level, 95% for comparability with other studies, confidence intervals based on the Grenwood formula for the variance of a survival probability).
- Overall survival (Cohort A and C) [ Time Frame: Date of pathologic diagnosis to date of death, assessed up to 2 years ]Will be described using Kaplan Meier estimates.
- CNS and/or systemic disease control (Cohort B) [ Time Frame: At 12 weeks ]
- Incidence of toxicity, graded according to National Cancer Institute Common Terminology for Adverse Events version 4.0 (Cohorts A, B, and C) [ Time Frame: Up to 2 years ]Toxicity will be tabulated by organ system and grade.
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||January 2019|
|Estimated Primary Completion Date:||January 2018 (Final data collection date for primary outcome measure)|
Experimental: Treatment (pegylated irinotecan NKTR 102)
Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: pegylated irinotecan NKTR 102
Other Names:Other: laboratory biomarker analysis
For cohort A and Cohort C, to determine the CNS disease control rate (number of patients with stable disease or partial response or complete response / total number of treated patients) at 12 weeks following treatment with etirinotecan pegol in patients with advanced NSCLC or with MBC with refractory brain metastases
Cohorts A and C:
- To measure the overall disease control rate and response rate for patients receiving study therapy
- To measure the systemic (non CNS) disease control rate and response rate for patients receiving study therapy
- To observe the progression free survival of the study population
- To observe the overall survival of the study population
- To observe CNS and systemic disease control in SCLC
Cohorts A, B and C:
- To determine the safety profile of etirinotecan pegol (NKTR 102)
Please refer to this study by its ClinicalTrials.gov identifier: NCT02312622
|Contact: Sophie Bertrandfirstname.lastname@example.org|
|United States, California|
|Stanford University, School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Sophie Bertrand 650-723-4467 email@example.com|
|Principal Investigator: Joel W. Neal|
|Principal Investigator:||Joel Neal||Stanford University Hospitals and Clinics|