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A Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin to Treat Small Cell Lung Cancer Following Platinum-Based Chemotherapy

Primary Purpose

Small Cell Lung Cancer (SCLC)

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TAS-102
Amrubicin (Japan)
Topotecan (Japan/Europe)
Sponsored by
Taiho Oncology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer (SCLC) focused on measuring Second line Small Cell Lung Cancer, (SCLC), Refractory or Sensitive to First line Platinum based chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Has provided written informed consent
  2. Is ≥18 years of age for patients enrolled in Europe; or ≥20 years of age for patients enrolled in Japan
  3. Has definitive histologically or cytologically confirmed SCLC (limited or extensive disease)
  4. Has progressed or had recurrence within 30 days prior to randomization
  5. Has at least one measurable lesion, as defined by RECIST criteria version 1.1
  6. ECOG performance status of 0, 1, or 2
  7. Is able to take medications orally
  8. Has adequate organ function (bone marrow, kidney and liver)
  9. 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 Criteria:

  1. 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)
  2. Certain serious illnesses or medical condition(s)
  3. 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
  4. Has received TAS-102
  5. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
  6. Is a pregnant or lactating female

Sites / Locations

  • Klinikum Mannheim GmbH Universitaetsklinikum
  • Lungenklinik Heckeshorn- HELIOS Kliniken GmbH
  • LungenClinic Grosshansdorf
  • Klinikum Koeln-Merheim
  • St. Hildegardis-Krankenhaus- Katholisches Klinikum Mainz
  • LMU-Campus Innenstadt
  • Azienda Ospedaliero-Universitaria S. Luigi Gonzaga
  • IRCCS Centro di Riferimento Oncologico di Aviano, Divisione Oncologia Medica A
  • Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
  • Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico
  • Azienda Ospedaliera Instituti Ospitalieri di Cremona
  • Azienda Ospedaliera Universitaria Careggi
  • IEO Istituto Europeo di Oncologia
  • Azienda Ospedaliera San Gerardo U.O Oncologia Medica
  • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
  • A.O.V.V. Ospedale Eugenio Morelli-Sondalo
  • National Cancer Center Hospital East
  • National Kyushi Cancer Center
  • Hyogo Cancer Center
  • Saitama Cancer Center
  • Shizuoka Cancer Center
  • Nippon Medical School Hospital
  • Cancer Institute Hospital of Japanese Foundation for Cancer Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAS-102

Investigator Choice of Amrubicin or Topotecan

Arm Description

Investigator Choice of Amrubicin (Japan only) or Topotecan (Europe and Japan)

Outcomes

Primary Outcome Measures

Progression-free survival
Tumor assessments will be performed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 every 6 weeks during study treatment, and every 8 weeks after treatment is completed. Tumor assessments will be performed from Day 1, Cycle 1 until radiologic progression develops or the start of new anticancer treatment, for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met.

Secondary Outcome Measures

Overall survival
Safety monitoring including adverse events, vital signs, and laboratory assessments
Standard safety monitoring will be performed and adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Full Information

First Posted
July 12, 2013
Last Updated
July 11, 2014
Sponsor
Taiho Oncology, Inc.
Collaborators
Taiho Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01904253
Brief Title
A Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin to Treat Small Cell Lung Cancer Following Platinum-Based Chemotherapy
Official Title
An Open-Label, Randomized, Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin in Patients Requiring Second-Line Chemotherapy for Small Cell Lung Cancer That is Refractory or Sensitive to First-Line Platinum-Based Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
The preliminary data does not suggest any safety signal, but an ad hoc interim analysis showed an imbalance of PFS between the two arms
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Oncology, Inc.
Collaborators
Taiho Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 time may pass without disease progression, and the safety of TAS-102.
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 to first-line platinum-based chemotherapy. Investigator's choice of therapy is defined as second-line chemotherapy with IV topotecan (Europe/Japan) or IV amrubicin (Japan). Patients will be stratified by response to first-line platinum-based chemotherapy (sensitive vs refractory). Sensitive patients are defined as patients who did not progress within 90 days after the last dose, and refractory patients are defined as patients who never responded or who responded but had radiologic progression < 90 days after the last dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer (SCLC)
Keywords
Second line Small Cell Lung Cancer, (SCLC), Refractory or Sensitive to First line Platinum based chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAS-102
Arm Type
Experimental
Arm Title
Investigator Choice of Amrubicin or Topotecan
Arm Type
Active Comparator
Arm Description
Investigator Choice of Amrubicin (Japan only) or Topotecan (Europe and Japan)
Intervention Type
Drug
Intervention Name(s)
TAS-102
Intervention Description
35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
Intervention Type
Drug
Intervention Name(s)
Amrubicin (Japan)
Other Intervention Name(s)
Calsed
Intervention Description
Patients will receive treatment administered according to the country-specific approved prescribing information
Intervention Type
Drug
Intervention Name(s)
Topotecan (Japan/Europe)
Other Intervention Name(s)
Hycamptin, Hycamtin
Intervention Description
Patients will receive treatment administered according to the country-specific approved prescribing information
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Tumor assessments will be performed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 every 6 weeks during study treatment, and every 8 weeks after treatment is completed. Tumor assessments will be performed from Day 1, Cycle 1 until radiologic progression develops or the start of new anticancer treatment, for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met.
Time Frame
Every 6 weeks from the start of study treatment (Day 1, Cycle 1). Tumor assessments will be performed until radiologic progression develops or the start of new anticancer treatment.
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
Survival status will be collected at 8-week intervals until death, for up to 12 months after the first dose of study medication for the last patient randomized or until the target number of events (deaths) is met, whichever is later.
Title
Safety monitoring including adverse events, vital signs, and laboratory assessments
Description
Standard safety monitoring will be performed and adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time Frame
Through 30 days following last administration of study medication or until initiation of new anticancer treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorgio Scagliotti, MD
Organizational Affiliation
University of Turin San Luigi Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kaoru Kubota, MD, PhD
Organizational Affiliation
Nippon Medical School Hospital Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Mannheim GmbH Universitaetsklinikum
City
Mannheim
State/Province
Baden-Württemberg
Country
Germany
Facility Name
Lungenklinik Heckeshorn- HELIOS Kliniken GmbH
City
Berlin
Country
Germany
Facility Name
LungenClinic Grosshansdorf
City
Grosshansdorf
Country
Germany
Facility Name
Klinikum Koeln-Merheim
City
Koplin
Country
Germany
Facility Name
St. Hildegardis-Krankenhaus- Katholisches Klinikum Mainz
City
Mainz
Country
Germany
Facility Name
LMU-Campus Innenstadt
City
Muenchen
Country
Germany
Facility Name
Azienda Ospedaliero-Universitaria S. Luigi Gonzaga
City
Orbassano
State/Province
Turin
Country
Italy
Facility Name
IRCCS Centro di Riferimento Oncologico di Aviano, Divisione Oncologia Medica A
City
Aviano
Country
Italy
Facility Name
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
City
Bari
Country
Italy
Facility Name
Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico
City
Catania
Country
Italy
Facility Name
Azienda Ospedaliera Instituti Ospitalieri di Cremona
City
Cremona
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
Country
Italy
Facility Name
IEO Istituto Europeo di Oncologia
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliera San Gerardo U.O Oncologia Medica
City
Monza
Country
Italy
Facility Name
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
City
Reggio Emilia
Country
Italy
Facility Name
A.O.V.V. Ospedale Eugenio Morelli-Sondalo
City
Sondalo
Country
Italy
Facility Name
National Cancer Center Hospital East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Kyushi Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Hyogo Cancer Center
City
Hyogo
ZIP/Postal Code
673-8588
Country
Japan
Facility Name
Saitama Cancer Center
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Cancer Institute Hospital of Japanese Foundation for Cancer Research
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27597276
Citation
Scagliotti G, Nishio M, Satouchi M, Valmadre G, Niho S, Galetta D, Cortinovis D, Benedetti F, Yoshihara E, Makris L, Inoue A, Kubota K. A phase 2 randomized study of TAS-102 versus topotecan or amrubicin in patients requiring second-line chemotherapy for small cell lung cancer refractory or sensitive to frontline platinum-based chemotherapy. Lung Cancer. 2016 Oct;100:20-23. doi: 10.1016/j.lungcan.2016.06.023. Epub 2016 Jun 27.
Results Reference
derived

Learn more about this trial

A Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin to Treat Small Cell Lung Cancer Following Platinum-Based Chemotherapy

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