Small Cell Lung Cancer MedDRA version: 16.0 Level: PT Classification code 10041068 Term: Small cell lung cancer extensive stage System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Palifosfamide-tris
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Palifosfamide (isophosphoramide mustard)
CA
Sponsors
ZIOPHARM Oncology, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Documented extensive-stage small cell lung cancer · Patient has received no prior chemotheraphy, adjuvant therapy, or radiotherapy for lung cancer · ECOG Perforamce Status of 0, 1 or 2 · Adequate bone marrow and organ function based on the results of protocol- specified laboratory tests · Male and female patients must agree to use a highly reliable method of birth control during study participation · Able to provide informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 328 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 220
Exclusion criteria
Exclusion criteria: · Previously untreated (non-irradiated), symptomatic brain metastases · Known allergy to any of the study drugs or their excipients · Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol, based on screening tests, physical examination and medical history (as specifically defined in the clinical protocol). · Any malignancy other than small cell lung cancer within the last 5 years prior to randomization, with the exception of cervical carcinoma in situ, nonmelanoma skin cancer, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated with no evidence of recurrent or residual disease. (Exception: Subjects with a history of malignancy other than small cell lung cancer may be enrolled after consulation with the medical monitor provided the patient’s prognosis is best defined by the extensive-stage small cell lung cancer). · Currently pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the efficacy of palifosfamide-tris in combination with carboplatin and etoposide (PaCE) chemotherapy to carboplatin and etoposide (CE) alone, as measured by overall survival (OS), in chemotherapy naïve subjects with extensive-stage SCLC.; Secondary Objective: The secondary objectives are to: - Assess secondary efficacy endpoints including time to progression, objective response rate (ORR), response duration, and effects on quality of life (QOL) and disease-related symptoms. - Assess potential prognostic factors for OS (i.e., performance status, age, and gender). - Assess the safety of PaCE chemotherapy in the study population. - Collect tumor tissue samples for future analyses of potential biomarkers that may correlate with objective tumor response and/or clinical outcome. ;Primary end point(s): The primary efficacy variable, overall survival, is defined as the time from randomization to the date of death.;Timepoint(s) of evaluation of this end point: The study design uses an adaptive group sequential approach with sample size reestimation at the interim analysis. This interim analysis will be performed after 125 deaths have been observed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): For study purposes, data for tumor-related endpoints (e.g., ORR) will be determined by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.1 Tumor-related secondary efficacy variables are defined as the following: - TTP (time to progression): Time from randomization to the first date of PD. For subjects who have not progressed at the time of analysis, their TTP will be censored as of their last date of disease evaluation. Death due to disease is considered to be progressive disease. - Objective response rate (ORR): Proportion of subjects achieving a confirmed PR or CR according to RECIST v1.1 during study treatment or within 21 days following termination of study treatment. All objective responses (CR or PR) require confirmation by a repeat tumor assessment at least 4 weeks (28 days) after the response is first observed in order for the response to be considered confirmed. - Objective response duration: Time from the date of first objective response (PR or CR), with subsequent confirmation, until the date of PD or the occurrence of death (if death occurs earlier). Duration of response in subjects who have not progressed or died at the time of analysis will be censored as of the date of their last tumor assessment. ; Timepoint(s) of evaluation of this end point: Secondary efficacy endpoints include ORR, PFS, duration of response and changes in QOL and disease-related symptoms. Tumor-related endpoints will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines. | — |
Countries
Australia, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Poland, Russian Federation, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactJill Buck
Ziopharm Oncology Inc.
Outcome results
None listed