Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Recruiting NCT05652686 - A Study of PT217 in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study) Phase 1/Phase 2
Recruiting NCT05027100 - Tislelizumab Combined With Anlotinib and 2-cycles Irinotecan as Second Line Treatment of SCLC N/A
Active, not recruiting NCT03708328 - A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors Phase 1
Recruiting NCT05158491 - Safety, Tolerability and Preliminary Efficacy of JK1201I in Patients With SCLC Phase 1/Phase 2
Recruiting NCT05740566 - Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer Phase 3
Completed NCT04285866 - Spanish Real World Data on Patients Treated With Durvalumab After Chemoradiotherapy.
Completed NCT03066778 - A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604) Phase 3
Not yet recruiting NCT04727853 - Study of Irinotecan Liposome Injection as Second-line Regimen in Patients With Small Cell Lung Cancer (SCLC) Phase 2
Withdrawn NCT02030184 - Phase I/II Trial of Rhenium 188-P2045 in Small Cell Lung Cancer and Other Advanced Neuroendocrine Carcinomas Phase 1/Phase 2
Completed NCT03538028 - A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies Phase 1
Withdrawn NCT01210131 - Hypoxia-guided Radiotherapy With Cisplatin-etoposide in Stage I-III : Small Cell Lung Cancer(SCLC) N/A
Terminated NCT02934503 - Study of Pembrolizumab and Chemotherapy With or Without Radiation in Small Cell Lung Cancer (SCLC) Phase 2
Completed NCT02580994 - Pembrolizumab in Untreated Extensive SCLC Phase 2
Completed NCT03811652 - A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT02628067 - Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158) Phase 2
Active, not recruiting NCT02769832 - Nab-Paclitaxel With Gemcitabine for Relapsed Small Cell Cancer Phase 2
Completed NCT02069158 - Dose Finding Study Of PF-05212384 With Paclitaxel And Carboplatin In Patients With Advanced Solid Tumor Phase 1
Recruiting NCT03460977 - PF-06821497 Treatment Of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma Phase 1