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Trial record 1 of 1 for:    NCT03061812
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Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE) (TAHOE)

This study is currently recruiting participants.
Verified October 2017 by AbbVie
Sponsor:
ClinicalTrials.gov Identifier:
NCT03061812
First Posted: February 23, 2017
Last Update Posted: November 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie
  Purpose
The purpose of this randomized, open-label, 2-arm, Phase 3 study is to assess the assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic Small Cell Lung Cancer (SCLC) with high levels of delta-like protein 3 (DLL3) and who have first disease progression during or following front-line platinum-based chemotherapy.

Condition Intervention Phase
Small Cell Lung Cancer Drug: Rovalpituzumab tesirine Drug: Topotecan Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared With Topotecan for High DLL3 Expressing Small Cell Lung Cancer (SCLC) Subjects With First Relapse/Recurrence Following Front-Line Platinum-Based Chemotherapy (TAHOE)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: Approximately 23 months ]
    ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  • Overall Survival (OS) [ Time Frame: Approximately 34 months ]
    Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause.


Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Approximately 34 months ]
    PFS is based on independent review of radiographic assessment, defined as the time from randomization to documented disease progression or death from any cause, whichever occurs earlier.

  • Duration of Objective Response (DOR) [ Time Frame: Approximately 34 months ]
    DOR is defined as the time between the date of first response (CR or PR, whichever is recorded first) to the date of the first documented tumor progression (per RECIST version 1.1) or death due to any cause, whichever comes first.

  • Change from baseline of the Physical functioning scale score in QLQ-C15-PAL [ Time Frame: Approximately 34 months ]
    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC OLQ-C15-PAL) is a questionnaire developed to assess the quality of life of palliative cancer care. Higher scores reflect greater symptom burden.


Estimated Enrollment: 411
Actual Study Start Date: April 10, 2017
Estimated Study Completion Date: May 2, 2020
Estimated Primary Completion Date: September 19, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rovalpituzumab tesirine
Rovalpituzumab tesirine intravenous administration on Day 1 of a 42-Day cycle for 2 cycles.
Drug: Rovalpituzumab tesirine
Administered on Day 1 via intravenous infusion in a 42-day cycle for 2 cycles.
Active Comparator: Topotecan
Topotecan intravenous on Days 1 through 5 of each 21-Day cycle.
Drug: Topotecan
Administered on Day 1-5 via intravenous infusion in a 21-day cycle.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must have histologically or cytologically confirmed advanced or metastatic Small Cell Lung Cancer (SCLC) with documented first disease progression during or following front-line platinum-based systemic regimen
  • Tumor must have high Delta-like protein 3 (DLL3) expression defined as having ≥ 75% tumor cells staining positive according to the VENTANA DLL3 (SP347) IHC Assay.
  • Participant must have measurable disease, as defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 per the Central Radiographic Assessment Committee (CRAC).
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Participant must have recovery to Grade 0 or 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration.

Exclusion Criteria:

  • Participant has a documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class (NYHA) III - IV within 6 months prior to their first dose of study drug.
  • Participant has known leptomeningeal metastases.
  • Participant has received more than one prior systemic therapy regimen for SCLC.
  • Participant had a serious infection within 2 weeks prior to randomization, including any Grade 3 or higher viral, bacterial, or fungal infection.
  • Participant has a history of active malignancies other than SCLC within the past 2 years prior to study entry, with the exception of in situ cancer which was curatively treated.
  • Participant had prior exposure to topotecan, irinotecan or any other topoisomerase I inhibitors.
  Contacts and Locations
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): NCT03061812


Contacts
Contact: AbbVie_Call Center 847.283.8955 abbvieclinicaltrials@abbvie.com

  Hide Study Locations
Locations
United States, Alabama
Clearview Cancer Institute /ID# 155873 Recruiting
Huntsville, Alabama, United States, 35805
University of South Alabama Mitchell Cancer Institute /ID# 158151 Recruiting
Mobile, Alabama, United States, 36604
United States, Arkansas
Highlands Oncology Group /ID# 155902 Recruiting
Fayetteville, Arkansas, United States, 72703
Central Arkansas Radiation Therapy Institute /ID# 156982 Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
UCSD Moores Cancer Center, US /ID# 156965 Recruiting
La Jolla, California, United States, 92093-0698
Los Angeles Hematology Oncology Medical Group /ID# 155879 Recruiting
Los Angeles, California, United States, 90017
University of California, Davis Comprehensive Cancer Center /ID# 157001 Recruiting
Sacramento, California, United States, 95817
St Jude Hospital dba St Joseph Heritage Healthcare /ID# 155899 Recruiting
Santa Rosa, California, United States, 95403
Innovative Clinical Research Institute /ID# 157090 Recruiting
Whittier, California, United States, 90603
United States, Delaware
Christiana Care Health Services, Inc. /ID# 158171 Recruiting
Newark, Delaware, United States, 19713
United States, Georgia
Georgia Cancer Center Specialists /ID# 160206 Recruiting
Atlanta, Georgia, United States, 30342
United States, Illinois
NorthShore University HealthSystem /ID# 157054 Not yet recruiting
Evanston, Illinois, United States, 60201
Ingalls Memorial Hospital /ID# 155871 Recruiting
Harvey, Illinois, United States, 60426
United States, Indiana
Goshen Center for Cancer Care /ID# 155946 Recruiting
Goshen, Indiana, United States, 46526
United States, Kentucky
University Medical Center, Inc. /ID# 155947 Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Clinic Foundation /ID# 160807 Recruiting
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Dana Farber Cancer Institute /ID# 160210 Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Edward W. Sparrow Hospital Association /ID# 157021 Recruiting
Lansing, Michigan, United States, 48912
United States, Ohio
Gabrail Cancer Center Research /ID# 155920 Recruiting
Canton, Ohio, United States, 44718
United States, Oregon
Oregon Health & Science University (OHSU) /ID# 157055 Recruiting
Portland, Oregon, United States, 97239
United States, Tennessee
Nebraska Hematology Oncology, PC /ID# 155900 Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
University Medical Center Brackenridge /ID# 156967 Recruiting
Austin, Texas, United States, 78701
United States, Washington
Seattle Cancer Care Alliance /ID# 162626 Recruiting
Seattle, Washington, United States, 98109
Medical Oncology Associates, PS (dba Summit Cancer Centers) /ID# 156856 Recruiting
Spokane, Washington, United States, 99208
United States, West Virginia
West Virginia University, School of Medicine /ID# 155872 Recruiting
Morgantown, West Virginia, United States, 26506
Australia
Ballarat Health Service /ID# 158904 Recruiting
Ballarat, Australia, 3350
Blacktown Hospital /ID# 158907 Recruiting
Blacktown, Australia, 2148
The Prince Charles Hospital /ID# 158897 Recruiting
Chermside, Australia, 4032
Austin Health /ID# 158898 Not yet recruiting
Heidelberg, Australia, 3084
Southern Medical Day Care Center /ID# 158853 Recruiting
Wollongong, Australia, 2500
Belarus
Republican Research and Practice Centre of Oncology /ID# 159325 Not yet recruiting
Agro-town Lesnoy, Belarus, 223040
Inst. of healthcare Mogilev Regional Oncologic dispensary /ID# 159326 Recruiting
Mogilev, Belarus, 212018
Belgium
CHU Saint-Pierre /ID# 159521 Not yet recruiting
Bruxelles, Belgium, 1000
Cliniques universitaires Saint-Luc /ID# 158751 Not yet recruiting
Bruxelles, Belgium, 1200
Grand Hopital de Charleroi /ID# 158748 Not yet recruiting
Charleroi, Belgium, 6000
Hopital de Jolimont /ID# 159755 Not yet recruiting
La Louviere, Belgium, 7100
Universitair Ziekenhuis Leuven /ID# 158752 Not yet recruiting
Leuven, Belgium, 3000
CHU de Liege Sart Tilman /ID# 158753 Not yet recruiting
Liege, Belgium, 4000
CHU de Charleroi - Hopital Andre Vesale /ID# 159756 Not yet recruiting
Montigny-le-Tilleul, Belgium, 6110
Bulgaria
UMHAT Sveti Ivan Rilski EAD /ID# 159642 Not yet recruiting
Sofia, Bulgaria, 1431
UMHAT Tsaritsa Joanna - ISUL /ID# 159641 Not yet recruiting
Sofia, Bulgaria, 1527
Canada
Cross Cancer Institute /ID# 159519 Recruiting
Edmonton, Canada, T6G 1Z2
Juravinski Cancer Centre /ID# 159514 Recruiting
Hamilton, Canada, L8V 5C2
Hopital du Sacre-Coeur de Montreal /ID# 159515 Recruiting
Montreal, Canada, H4J1C5
CHU de Quebec-Universite Laval /ID# 159093 Not yet recruiting
Quebec, Canada, G1J 1Z4
Croatia
Klinicki bolnicki Centar Rijeka /ID# 159501 Recruiting
Rijeka, Croatia, 51000
Klinicki Bolnicki Centar Sestre Milosrdnice /ID# 158811 Not yet recruiting
Zagreb, Croatia, 10000
Klinicki bolnicki Centar Zagreb /ID# 159502 Not yet recruiting
Zagreb, Croatia, 10000
Czechia
Krajska nemocnice Liberec a.s. /ID# 159653 Recruiting
Liberec 1, Czechia, 46063
Nemocnice Na Plesi s.r.o. /ID# 161190 Recruiting
Nova Ves Pod Plesi, Czechia, 262 04
Eticka Komise IKEM a Thomayerovy nemocnice /ID# 159061 Recruiting
Prague 4, Czechia, 14059
Denmark
Rigshospitalet, Finsen Centre /ID# 158051 Recruiting
Copenhagen, Denmark, 2100
Herlev Hospital /ID# 158049 Recruiting
Herlev, Denmark, 2730
Odense University Hospital /ID# 158050 Recruiting
Odense C, Denmark, 5000
France
CHI Creteil-Service de Pneumologie /ID# 162684 Recruiting
Creteil, France, 94000
Centre Leon Berard /ID# 160561 Recruiting
Lyon, France, 69008
Assistance Publique-Hopitaux de Marseille Hopital Nord /ID# 160554 Recruiting
Marseille, France, 13105
Assistance Publique- Hopitaux de Paris Hopital TENON /ID# 160552 Recruiting
Paris, France, 75020
Hopital du Haut Leveque /ID# 160558 Recruiting
Pessac, France, 33604
Hospital de Pontchaillou- CHU Rennes /ID# 160555 Recruiting
RENNES Cedex 9, France, 35033
Germany
Krankenhaus Martha-Maria Halle Dolau GGMBII /ID# 158796 Recruiting
Halle, Germany, 6120
Thoraxklinik Heidelberg gGmbH /ID# 159169 Not yet recruiting
Heidelberg, Germany, 69126
Klinikum Kassel /ID# 158788 Not yet recruiting
Kassel, Germany, 34125
Greece
General Hospital of Chest Diseases of Athens Sotiria /ID# 159165 Recruiting
Athens, Greece, 115 27
Metropolitan Hospital /ID# 159162 Recruiting
Athens, Greece, 18547
Hungary
Semmelweis Egyetem AOK /ID# 161197 Recruiting
Budapest, Hungary, 1125
Orszagos Koranyi es Pulmonologiai Intezet /ID# 158967 Recruiting
Budapest, Hungary, H-1122
Debreceni Egyetem /ID# 161209 Recruiting
Debrecen, Hungary, 4032
Veszprem Megyei Tuedoegyogyintezet Intezeti Kutatasetikai Bi /ID# 162607 Recruiting
Farkasgyepue, Hungary, H-8582
Petz Aladar Megyei Oktato Korhaz /ID# 158978 Recruiting
Gyor, Hungary, 9024
Matrai Gyogyintezet /ID# 158979 Recruiting
Matrahaza, Hungary, H-3233
Italy
AUSL 8 Arezzo Ospedale San Donato /ID# 160967 Recruiting
Arezzo, Italy, 52100
Istituto Europeo di Oncologia /ID# 158942 Not yet recruiting
Milano, Italy, 20141
Azienda Ospedaliera Universitaria San Luigi Gonzaga /ID# 158945 Recruiting
Orbassano (TO), Italy, 10043
Ospedale Santa Maria delle Croci /ID# 158940 Recruiting
Ravenna, Italy, 48121
IFO Istituto Nazionale Tumori Regina Elena /ID# 158941 Recruiting
Rome, Italy, 00144
Japan
Matsusaka City Hospital /ID# 166126 Not yet recruiting
Matsusaka-shi, Mie, Japan
National Hospital Organization Hokkaido Cancer Center /ID# 165237 Not yet recruiting
Sapporo-Shi, Japan
Sendai Kousei Hospital /ID# 166061 Not yet recruiting
Sendai, Japan
Tokushima University Hospital /ID# 165812 Not yet recruiting
Tokushima-shi, Tokushima, Japan
Korea, Republic of
Dong-A University Hospital /ID# 159296 Not yet recruiting
Busan, Korea, Republic of, 49201
Chungbuk National University Hospital /ID# 159291 Not yet recruiting
Cheongju-si, Korea, Republic of, 28644
Chonnam National University Hwasun Hospital /ID# 159294 Not yet recruiting
Jeonnam, Korea, Republic of, 58128
Severance Hospital, Yonsei University Health System /ID# 159288 Not yet recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center /ID# 159290 Not yet recruiting
Seoul, Korea, Republic of, 05505
Korea University Guro Hospital /ID# 159293 Not yet recruiting
Seoul, Korea, Republic of, 08308
Latvia
Pauls Stradins Clinical University Hospital, Clinic of Oncol /ID# 158713 Recruiting
Riga, Latvia, LV-1002
Riga East Clinical University Hospital, Oncology Center of /ID# 158714 Recruiting
Riga, Latvia, LV-1079
Netherlands
University Medical Center Groningen /ID# 158088 Recruiting
Groningen, Netherlands, 9713 GZ
St.Jansdal ziekenhuis /ID# 158652 Recruiting
Harderwijk, Netherlands, 3844 DG
Isala Klinieken /ID# 158653 Recruiting
Zwolle, Netherlands, 8025 AB
Poland
Copernicus PL Sp. z o. o., Wojewodzkie Centrum Onkologii /ID# 160538 Recruiting
Gdansk, Poland, 80-219
Portugal
Unidade Local Saude Matosinhos, EPE-Hospital Pedro Hispano /ID# 158682 Recruiting
Matoshinhos, Portugal, 4464-543
Romania
Spitalul Judetean de Urgenta Alba Iulia /ID# 160846 Recruiting
Alba, Romania, 510077
S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 160847 Not yet recruiting
Craiova, Dolj, Romania, 200347
Oncocenter Oncologie Clinica SRL /ID# 160848 Recruiting
Timisoara, Timis, Romania, 300166
Russian Federation
LLC BioEq Ltd. /ID# 159310 Not yet recruiting
Saint-Petersburg, Russian Federation, 197342
N.N. Petrov Science-Research Institute of Oncology /ID# 159312 Not yet recruiting
Saint-Petersburg, Russian Federation, 197758
Smolensk Regional Oncology Clinical Dispensary /ID# 159314 Not yet recruiting
Smolensk Region, Russian Federation, 214000
Serbia
Institut za onkologiju i radiologiju Srbije /ID# 160058 Not yet recruiting
Belgrade, Serbia, 11000
Klinicki centar Srbije /ID# 160024 Not yet recruiting
Belgrade, Serbia, 11000
Institute For Pulmonary Diseases of Vojvodina /ID# 158813 Not yet recruiting
Sremska Kamenica, Serbia, 21204
Singapore
National University Hospital /ID# 158802 Recruiting
Singapore, Singapore, 119228
National Cancer Centre Singapore /ID# 158803 Recruiting
Singapore, Singapore, 169610
Spain
Hosp. Sta Creu i Sant Pau /ID# 159028 Recruiting
Barcelona, Spain, 08025
Hospital de Barcelona /ID# 159031 Not yet recruiting
Barcelona, Spain, 08036
Hospital Universitario HM Sanchinarro /ID# 159024 Recruiting
Madrid-Espana, Spain, 28050
Hosp. Gral. Univ. Gregorio Maranon /ID# 159025 Not yet recruiting
Madrid, Spain, 28009
Hospital Clinico Universitario de Valencia /ID# 159027 Recruiting
Valencia, Spain, 46010
Sweden
Sahlgrenska Universitetssjukhuset /ID# 159534 Not yet recruiting
Goteborg, Sweden, SE-413 46
Akademiska sjukhuset /ID# 159050 Not yet recruiting
Uppsala, Sweden, 751 85
Taiwan
Taichung Veterans General Hospital /ID# 158866 Recruiting
Taichung, R.O.C, Taiwan, 40705
National Cheng Kung University Hospital /ID# 158844 Recruiting
Tainan, Taiwan, 704
National Taiwan University Hospital /ID# 158865 Recruiting
Taipei City, Taiwan, 100
Tri-Service General Hospital /ID# 158985 Recruiting
Taipei City, Taiwan, 114
Turkey
Hacettepe Universitesi Tip Fakultesi Sihhiye Yerleskesi /ID# 159238 Recruiting
Altindag/Ankara, Turkey, 06100
Inonu Universitesi Turgut Ozal Tip Merkezi ic Hastaliklari /ID# 159241 Recruiting
Battalgazi/Malatya, Turkey, 44280
Ege University Medical Faculty /ID# 159239 Not yet recruiting
Izmir, Turkey, 35100
Ataturk Gogus Hastaliklari veGogus /ID# 160056 Not yet recruiting
Kecioren/Ankara, Turkey, 06280
Dr. Suat Seren Gogus Hastaliklari /ID# 159240 Not yet recruiting
Yenisehir/Izmir, Turkey, 35110
Ukraine
Municipal institution "Chernivtsi Regional Clinical Oncology /ID# 159867 Not yet recruiting
Chernivtsi, Ukraine, 58013
Municipal institution Multifield City Clinical Hospital /ID# 159121 Recruiting
Dnipro, Ukraine, 49102
Regional Center of Oncology /ID# 159123 Not yet recruiting
Kharkiv, Ukraine, 61070
Medical and Diagnostic Center PE PMC ''Acinus'' /ID# 159125 Recruiting
Kropyvnytskyi, Ukraine, 25006
Kryviy Rih Oncology Center /ID# 159119 Recruiting
Kryviy Rih, Ukraine, 50048
Treatment and prevention institution Volyn regional oncology /ID# 159124 Not yet recruiting
Lutsk, Ukraine, 43018
Central Regional Clinical Hospital /ID# 159868 Not yet recruiting
Uzhgorod, Ukraine, 88000
Communal Institution Zaporizhzhia Regional Clinical Oncologi /ID# 159122 Recruiting
Zaporizhzhia, Ukraine, 69040
United Kingdom
Royal Preston Hospital /ID# 159578 Recruiting
Fulwood, Preston, United Kingdom, PR2 9HT
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Philip Komarnitsky, MD AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03061812     History of Changes
Other Study ID Numbers: M16-289
2016-003726-17 ( EudraCT Number )
First Submitted: February 20, 2017
First Posted: February 23, 2017
Last Update Posted: November 2, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AbbVie:
Small cell lung cancer (SCLC)
rovalpituzumab tesirine
metastatic
Delta-like protein 3 (DLL3)
topotecan

Additional relevant MeSH terms:
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
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents