Status:
TERMINATED
A Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin to Treat Small Cell Lung Cancer Following Platinum-Based Chemotherapy
Lead Sponsor:
Taiho Oncology, Inc.
Collaborating Sponsors:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Small Cell Lung Cancer (SCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to compare the effects of TAS-102 with either amrubicin or topotecan (drugs used in Small Cell Lung Cancer) on lung cancer to find out the effects on survival, how much ti...
Detailed Description
This is a multicenter, open-label, two-arm, randomized Phase 2 study of TAS-102 versus Investigator's choice of therapy in patients requiring second-line chemotherapy for SCLC refractory or sensitive ...
Eligibility Criteria
Inclusion
- Has provided written informed consent
- Is ≥18 years of age for patients enrolled in Europe; or ≥20 years of age for patients enrolled in Japan
- Has definitive histologically or cytologically confirmed SCLC (limited or extensive disease)
- Has progressed or had recurrence within 30 days prior to randomization
- Has at least one measurable lesion, as defined by RECIST criteria version 1.1
- ECOG performance status of 0, 1, or 2
- Is able to take medications orally
- Has adequate organ function (bone marrow, kidney and liver)
- Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
Exclusion
- Has cerebral metastases (unless metastases have been treated and controlled, metastases have been stable for at least 2-months post-intervention, and patient is not receiving corticosteroid treatment)
- Certain serious illnesses or medical condition(s)
- Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration
- Has received TAS-102
- Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
- Is a pregnant or lactating female
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01904253
Start Date
July 1 2013
End Date
June 1 2014
Last Update
September 5 2024
Active Locations (23)
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1
Klinikum Mannheim GmbH Universitaetsklinikum
Mannheim, Baden-Wurttemberg, Germany
2
Lungenklinik Heckeshorn- HELIOS Kliniken GmbH
Berlin, Germany
3
LungenClinic Grosshansdorf
Großhansdorf, Germany
4
Klinikum Koeln-Merheim
Koplin, Germany