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Trial record 35 of 59 for:    TAS-102

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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ClinicalTrials.gov Identifier: NCT01904253
Recruitment Status : Terminated (The preliminary data does not suggest any safety signal, but an ad hoc interim analysis showed an imbalance of PFS between the two arms)
First Posted : July 22, 2013
Last Update Posted : July 14, 2014
Sponsor:
Collaborator:
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Taiho Oncology, Inc.

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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer (SCLC) Drug: TAS-102 Drug: Amrubicin (Japan) Drug: Topotecan (Japan/Europe) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014


Arm Intervention/treatment
Experimental: TAS-102 Drug: TAS-102
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.

Active Comparator: Investigator Choice of Amrubicin or Topotecan
Investigator Choice of Amrubicin (Japan only) or Topotecan (Europe and Japan)
Drug: Amrubicin (Japan)
Patients will receive treatment administered according to the country-specific approved prescribing information
Other Name: Calsed

Drug: Topotecan (Japan/Europe)
Patients will receive treatment administered according to the country-specific approved prescribing information
Other Names:
  • Hycamptin
  • Hycamtin




Primary Outcome Measures :
  1. Progression-free survival [ 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. ]
    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 :
  1. 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. ]
  2. Safety monitoring including adverse events, vital signs, and laboratory assessments [ Time Frame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT01904253


Locations
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Germany
Klinikum Mannheim GmbH Universitaetsklinikum
Mannheim, Baden-Württemberg, Germany
Lungenklinik Heckeshorn- HELIOS Kliniken GmbH
Berlin, Germany
LungenClinic Grosshansdorf
Grosshansdorf, Germany
Klinikum Koeln-Merheim
Koplin, Germany
St. Hildegardis-Krankenhaus- Katholisches Klinikum Mainz
Mainz, Germany
LMU-Campus Innenstadt
Muenchen, Germany
Italy
Azienda Ospedaliero-Universitaria S. Luigi Gonzaga
Orbassano, Turin, Italy
IRCCS Centro di Riferimento Oncologico di Aviano, Divisione Oncologia Medica A
Aviano, Italy
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, Italy
Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico
Catania, Italy
Azienda Ospedaliera Instituti Ospitalieri di Cremona
Cremona, Italy
Azienda Ospedaliera Universitaria Careggi
Firenze, Italy
IEO Istituto Europeo di Oncologia
Milano, Italy
Azienda Ospedaliera San Gerardo U.O Oncologia Medica
Monza, Italy
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
Reggio Emilia, Italy
A.O.V.V. Ospedale Eugenio Morelli-Sondalo
Sondalo, Italy
Japan
National Cancer Center Hospital East
Chiba, Japan, 277-8577
National Kyushi Cancer Center
Fukuoka, Japan, 811-1395
Hyogo Cancer Center
Hyogo, Japan, 673-8588
Saitama Cancer Center
Saitama, Japan, 362-0806
Shizuoka Cancer Center
Shizuoka, Japan, 411-8777
Nippon Medical School Hospital
Tokyo, Japan, 113-8603
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Tokyo, Japan, 135-8550
Sponsors and Collaborators
Taiho Oncology, Inc.
Taiho Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Giorgio Scagliotti, MD University of Turin San Luigi Hospital
Principal Investigator: Kaoru Kubota, MD, PhD Nippon Medical School Hospital Cancer Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT01904253     History of Changes
Other Study ID Numbers: TPU-TAS-102-201
2012-004793-26 ( EudraCT Number )
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014
Keywords provided by Taiho Oncology, Inc.:
Second line Small Cell Lung Cancer, (SCLC), Refractory or Sensitive to First line Platinum based chemotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Topotecan
Amrubicin
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents