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

NCT ID: NCT01904253

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-06-30

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.

Conditions

Small Cell Lung Cancer (SCLC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAS-102

Group Type: EXPERIMENTAL

TAS-102

Intervention Type: DRUG

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.

Investigator Choice of Amrubicin or Topotecan

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

Group Type: ACTIVE_COMPARATOR

Amrubicin (Japan)

Intervention Type: DRUG

Patients will receive treatment administered according to the country-specific approved prescribing information

Topotecan (Japan/Europe)

Intervention Type: DRUG

Patients will receive treatment administered according to the country-specific approved prescribing information

Interventions

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.

Intervention Type: DRUG

Amrubicin (Japan)

Patients will receive treatment administered according to the country-specific approved prescribing information

Intervention Type: DRUG

Topotecan (Japan/Europe)

Patients will receive treatment administered according to the country-specific approved prescribing information

Intervention Type: DRUG

Other Intervention Names

Calsed; Hycamptin; Hycamtin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Taiho Oncology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giorgio Scagliotti, MD

Role: PRINCIPAL_INVESTIGATOR

University of Turin San Luigi Hospital

Kaoru Kubota, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nippon Medical School Hospital Cancer Center

Locations

Klinikum Mannheim GmbH Universitaetsklinikum

Mannheim, Baden-Wurttemberg, 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

München, , Germany

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

Florence, , Italy

IEO Istituto Europeo di Oncologia

Milan, , 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

National Cancer Center Hospital East

Chiba, , Japan

National Kyushi Cancer Center

Fukuoka, , Japan

Hyogo Cancer Center

Hyōgo, , Japan

Saitama Cancer Center

Saitama, , Japan

Shizuoka Cancer Center

Shizuoka, , Japan

Nippon Medical School Hospital

Tokyo, , Japan

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Tokyo, , Japan

Countries

Germany; Italy; Japan

References

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.

Reference Type: DERIVED

PMID: 27597276 (View on PubMed)

Other Identifiers

2012-004793-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TPU-TAS-102-201

Identifier Type: -

Identifier Source: org_study_id