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

Small Cell Lung Cancer (SCLC) Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01904253
• Other study ID #: TPU-TAS-102-201
• Secondary ID: 2012-004793-26
• Status: Terminated
• Phase: Phase 2
• First received: July 12, 2013
• Last updated: July 11, 2014
• Start date: July 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Taiho Oncology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer (SCLC)
• Small Cell Lung Carcinoma

Intervention

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.
• Amrubicin (Japan)
Patients will receive treatment administered according to the country-specific approved prescribing information
• Topotecan (Japan/Europe)
Patients will receive treatment administered according to the country-specific approved prescribing information

Locations

Country	Name	City	State
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	Klinikum Mannheim GmbH Universitaetsklinikum	Mannheim	Baden-Württemberg
Germany	LMU-Campus Innenstadt	Muenchen
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	Azienda Ospedaliero-Universitaria S. Luigi Gonzaga	Orbassano	Turin
Italy	Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia	Reggio Emilia
Italy	A.O.V.V. Ospedale Eugenio Morelli-Sondalo	Sondalo
Japan	National Cancer Center Hospital East	Chiba
Japan	National Kyushi Cancer Center	Fukuoka
Japan	Hyogo Cancer Center	Hyogo
Japan	Saitama Cancer Center	Saitama
Japan	Shizuoka Cancer Center	Shizuoka
Japan	Cancer Institute Hospital of Japanese Foundation for Cancer Research	Tokyo
Japan	Nippon Medical School Hospital	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Taiho Oncology, Inc.	Taiho Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

Germany,  Italy,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	No
Secondary	Overall survival		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.	No
Secondary	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	Through 30 days following last administration of study medication or until initiation of new anticancer treatment	Yes