Phase II Etirinotecan Pegol in Refractory Brain Metastases & Advanced Lung Cancer / Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02312622|
Recruitment Status : Active, not recruiting
First Posted : December 9, 2014
Last Update Posted : September 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|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|
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)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||July 2019|
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: laboratory biomarker analysis
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02312622
|United States, California|
|Stanford University, School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Joel Neal||Stanford University Hospitals and Clinics|