Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer

NCT02566993 | Completed Phase 3 Results

• 1 other identifier: PM1183-C-003-14
• Study Type: interventional
• Target: 613
• Locations: 20 countries
• Sites: 160

Brief Summary

Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as treatment in patients with small-cell lung cancer (SCLC) who failed one prior platinum-containing line.

Conditions

Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).

  Every three months up to death or study termination, a period of approximately 3.5 years

Secondary Outcomes (29)

• Difference in Overall Survival Between Lurbinectedin/Doxorubicin (DOX) and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 12 Months

  At 12 months

• Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 18 Months

  At 18 months

• Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 24 Months

  At 24 months

• Progression-free Survival (PFS) by Independent Review Committee

  Every six weeks up to progression disease, a period of approximately 3.5 years

• Progression-free Survival Rate at 6 Months by Independent Review Committee

  At 6 months

Study Arms (3)

Experimental Arm

EXPERIMENTAL

Lurbinectedin (PM01183) / Doxorubicin

Drug: Lurbinectedin (PM01183); Drug: Doxorubicin (DOX)

Control Arm 1

ACTIVE COMPARATOR

CAV (Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR))

Drug: Doxorubicin (DOX); Drug: Cyclophosphamide (CTX); Drug: Vincristine (VCR)

Control Arm 2

ACTIVE COMPARATOR

Topotecan

Drug: Topotecan

Interventions

Lurbinectedin (PM01183) DRUG

Experimental Arm

Doxorubicin (DOX) DRUG

Control Arm 1; Experimental Arm

Cyclophosphamide (CTX) DRUG

Control Arm 1

Vincristine (VCR) DRUG

Control Arm 1

Topotecan DRUG

Control Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary written informed consent
• Adult patients ≥ 18 years
• Histologically or cytologically confirmed diagnosis of limited or extensive stage SCLC which failed one prior platinum-containing regimen and with a chemotherapy-free interval (CTFI, time from the last dose of first-line chemotherapy to the occurrence of progressive disease) ≥ 30 days. Small-cell carcinoma of unknown primary site with or without neuroendocrine features confirmed in histology test(s) performed on metastatic lesion(s) are eligible, if Ki-67/MIB-1 is expressed in \>50% of tumor cells.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2.
• Adequate hematological, renal, metabolic and hepatic function within 7-10 days prior to randomization
• At least three weeks since last prior anticancer treatment and adequate recovery from prior treatment toxicity
• Prior radiotherapy (RT): At least four weeks since completion of whole-brain irradiation, at least two weeks since completion of prophylactic cranial irradiation, and to any other site.
• Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to six weeks after treatment discontinuation. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product dose.

You may not qualify if:

• More than one prior chemotherapy-containing line(re-challenge with the same initial regimen is not allowed)
• Patients who never received platinum-containing regimen for Small-cell Lung Cancer (SCLC)
• Prior treatment with PM01183, topotecan or anthracyclines.
• Limited-stage patients who are candidates for local or regional therapy
• Impending need for palliative RT or surgery for pathological fractures and/or for medullary compression within four weeks prior to randomization.
• Symptomatic or progressing or steroid requiring Central Nervous System (CNS) involvement disease at least four weeks prior to randomization
• Concomitant diseases/conditions:
• Angina, myocardial infarction, congestive heart failure or clinically significant valvular heart disease, arrhythmia, immunodeficiency (including known HIV seropositive), ongoing or treatment-requiring chronic liver disease, active infection, oxygen requirement within two weeks prior to randomization, diffuse interstitial lung disease (ILD) or pulmonary fibrosis, second invasive malignancy treated with chemotherapy and/or radiotherapy, invasive fungal infections requiring systemic treatment within 12 weeks of randomization.
• Pregnant or breast feeding women

Sponsors & Collaborators

• PharmaMar: lead

Study Sites (160)

Alabama Oncology

Birmingham, Alabama, 35243, United States

Location

Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers

Chandler, Arizona, 85224, United States

Location

St Jude Hospital Yorba Linda dba St Joseph Heritage Healthcare

Fullerton, California, 92835, United States

Location

Loma Linda University Medica! Center

Loma Linda, California, 92354, United States

Location

Innovative Clinical Research Institute (ICRI)

Whittier, California, 90603, United States

Location

Boca Raton Regional Hospital Lynn Cancer Institute

Boca Raton, Florida, 33486, United States

Location

Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

Fort Lauderdale, Florida, 33308, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Joliet Oncology-Hematology Associates, Ltd.

Joliet, Illinois, 60435, United States

Location

Healthcare Research Network III, LLC

Tinley Park, Illinois, 60487, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Montgomery Cancer Center

Mount Sterling, Kentucky, 40353, United States

Location

East Jefferson Hematology-Oncology Metairie Physicians Services, Inc

Metairie, Louisiana, 70006, United States

Location

Anne Arundel Medical Center Oncology and Hematology

Annapolis, Maryland, 21401, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

QUEST Research Institute

Royal Oak, Michigan, 48073, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital

Lebanon, New Hampshire, 03756, United States

Location

Summit Medical Group, P.A.

Florham Park, New Jersey, 07932, United States

Location

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, 28374, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, 74146, United States

Location

Associates in Hematology and Oncology, P.C.

Upland, Pennsylvania, 19013, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Tyler Hematology-Oncology PA

Tyler, Texas, 75701, United States

Location

Medical Oncology Associates PS (dba Summit Cancer Centers)

Spokane, Washington, 99208, United States

Location

MultiCare Institute for Research & Innovation

Tacoma, Washington, 98405, United States

Location

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Instituto Médico Especializado Alexander Fleming

C.a.b.a., Buenos Aires, C1426ANZ, Argentina

Location

Centro para la Atención Integral del Paciente Oncológico (CAIPO)

San Miguel de Tucumán, Tucumán Province, T4000GTB, Argentina

Location

Instituto Oncológico de Córdoba (IONC)

Córdoba, X5000HLX, Argentina

Location

CORI - Centro Oncológico Riojano Integral

La Rioja, F5300COE, Argentina

Location

ISIS Centro Especializado de Luce S.A.

Santa Fe, S3000FFU, Argentina

Location

Universitätsklinik für Innere Medizin III der PMU

Salzburg, 5020, Austria

Location

Medizinische Universität Wien / AKH Wien, Universitätsklinik für Innere Medizin I, Abteilung für klinische Onkologie

Vienna, 1090, Austria

Location

AZ Maria Middelares

Ghent, 9000, Belgium

Location

Clinique André Renard

Herstal, 4040, Belgium

Location

CHR de la citadelle

Liège, 4000, Belgium

Location

CHU de Liege - Sart Tilman

Liège, 4000, Belgium

Location

CHU Ambroise Paré

Mons, 7000, Belgium

Location

AZ Delta Campus Wilgenstraat

Roeselare, 8800, Belgium

Location

Nucleo de Oncologia da Bahia

Salvador, Estado de Bahia, 40170-110, Brazil

Location

lOP- Instituto de oncologia do paraná

Curitiba, Paraná, 80530-010, Brazil

Location

Coordenação de Pesquisa Clínica / Instituto Nacional de Câncer

Rio de Janeiro, Rio de Janeiro, 20231-092, Brazil

Location

Instituto COl de Pesquisa, Educação e Gestão

Rio de Janeiro, Rio de Janeiro, 22793-080, Brazil

Location

Associação Hospital de Caridade de Ijuí

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

lrmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital de clínicas de Porto alegre

Pôrto Alegre, Rio Grande do Sul, 90.035-903, Brazil

Location

Fundação PlO XII - Hospital de Câncer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

lnstituto de Ensino e Pesquisa Säo Lucas - IEP Säo Lucas

São Paulo, São Paulo, 01236-030, Brazil

Location

Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte

Panagyurishte, 4500, Bulgaria

Location

Multiprofile Hospital for Active Treatment of Women Health - "Nadezhda", Sofia; Clinic of Medical Oncology

Sofia, 1330, Bulgaria

Location

University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski", Sofia

Sofia, 1431, Bulgaria

Location

Acibadem City Clinic University Multiprofile Hospital for Active Treatment. EOOD, Sofia; Clinic of Medical Oncology

Sofia, 1784, Bulgaria

Location

Southlake Regional Health Centre - Stronach Regional Cancer Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

R.S. Mc Laughlin Durham Regional Cancer Centre, Lakeridge Health

Oshawa, Ontario, L1G 2B9, Canada

Location

Centre intégré de santé et de services sociaux de la Montérégie Centre

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Montreal Oncology Research Inc.

Montreal, Quebec, H1M 1B1, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Biron (Clinique René Laennec)

Mount Royal, Quebec, H3P 3H5, Canada

Location

Vitkovicka nemocnice, a.s., Plicni oddeleni

Ostrava, 703 84, Czechia

Location

Krajska zdravotni a.s. Masarykova nemocnice o.z.

Ústí nad Labem, 401 13, Czechia

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, 94010, France

Location

Centre Hospitalier Lyon Sud - Service de Pneumologie

Lyon, 69310, France

Location

Hôpital Nord - Service Oncologie Multidisciplinaire et Innovations Thérapeutiques

Marseille, 13915, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

CHU de Rennes Hôpital Pontchaillou

Rennes, 35033, France

Location

Central Clinic of Bad Berka

Bad Berka, 99437, Germany

Location

Vivantes Klinikum am Urban, Hämatologie und Onkologie

Berlin, 10967, Germany

Location

Evangelische Lungenklinik Berlin

Berlin, 13125, Germany

Location

Uniklinik Freiburg, Hämatologie, Onkologie & Stammzellransplantation

Freiburg im Breisgau, 79106, Germany

Location

Asklepios-Fachkliniken München Gauting

Gauting, 82131, Germany

Location

Center for Pneumology and Thoracic Surgery

Gerlingen, 70839, Germany

Location

Thoraxklinik Heidelberg GmbH

Heidelberg, 69126, Germany

Location

Lungenklinik Hemer

Hemer, 58675, Germany

Location

VIDIA Christliche Kliniken Karlsruhe

Karlsruhe, 76137, Germany

Location

Katholisches Klinikum Koblenz-Montabaur, Marienhof Koblenz

Koblenz, 56073, Germany

Location

Onkologische Schwerpunktpraxis Leer-Emden

Leer, 26789, Germany

Location

Klinik Löwenstein gGmbH, Med. Klinik II Onkologie

Löwenstein, 74245, Germany

Location

Uniklinikum Mannheim, TTZ, Medizinische Fakultät Mannheim

Mannheim, 68167, Germany

Location

Johannes Wesling Klinikum Minden, Klinik für Hämatologie, Onkologie und Palliativmedizin

Minden, 32429, Germany

Location

University of Munich LMU, Dpt. of Medicine V

München, 80336, Germany

Location

Städtisches Krankenhaus München Neuperlach

München, 81737, Germany

Location

Klinikum Bogenhausen, Städt. Klinikum München GmbH, Klinik für Pneumologie und Pneumologische Onkologie

München, 81925, Germany

Location

Klinikum Nürnberg Nord - Pneumologische Onkologie

Nuremberg, 90419, Germany

Location

Universitätsklinikum Ulm - Klinik für Innere Medizin II, Pneumologie

Ulm, 89081, Germany

Location

Medizinische Klinik I

Wuppertal, 42283, Germany

Location

University General Hospital of Heraklion - General Hospital "Venizeleio"

Heraklion, Crete, 71110, Greece

Location

General Hospital of Chest Diseases of Athens "Sotiria"

Athens, 11527, Greece

Location

General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Internal Medicine-Oncology Clinic

Athens, 14564, Greece

Location

General Hospital of Thessaloniki "G. Papanikolaou", Pulmonary Clinic, Aristotle University of Thessaloniki

Thessaloniki, 57010, Greece

Location

Országos Korányi TBC és Pulmonológiai Intézet, 6. Pulmonológia és Bronchologia

Budapest, 1121, Hungary

Location

Országos Korányi TBC és Pulmonológiai lntézet, 14. Pulmonológia

Budapest, 1121, Hungary

Location

Veszprém Megyei Tüdögyógyintézet, 3. Pulmonológiai Osztály

Farkasgyepű, 8582, Hungary

Location

Mátrai Gyógyintézet, Bronchológia

Mátraháza, 3233, Hungary

Location

Miskolci Semmelweis Kórház és Egyetemi Oktatókórház, Pulmonológiai Osztály

Miskolc, 3529, Hungary

Location

Fejér Megyei Szent György Egyetemi Oktató Kórház, I. Pulmonológiai Osztály

Székesfehérvár, 8000, Hungary

Location

Markusovszky Egyetemi Oktatókórház, Pulmonológiai Osztály

Szombathely, 9700, Hungary

Location

Szent Borbála Kórház, Pulmonológiai osztály

Tatabánya, 2800, Hungary

Location

Zala Megyei Kórház, Pulmonologia

Zalaegerszeg, 8900, Hungary

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, 20162, Italy

Location

IRCCS CROB (Istituto di Ricovero e Cura a Carattere Scientifico)

Rionero in Vulture, PZ, 85028, Italy

Location

Centro di Riferimento Oncologico di Aviano

Aviano, 33081, Italy

Location

Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" - Presidio G. Rodolico

Catania, 95123, Italy

Location

AOU Maggiore della Carità - SC Oncologia

Novara, 28100, Italy

Location

Istituto Oncologico Veneto

Padua, 35128, Italy

Location

lRCCS-Arcispedale Santa Maria Nuova

Reggio Emilia, 42123, Italy

Location

Policlinico Universitario Campus Bio-Medico

Roma, 00128, Italy

Location

ASST della Valtellina e dell' Alto Lario P.O. Di Sondrio

Sondrio, 23100, Italy

Location

Ain Wazein Hospital

Ain Wazein, El Chouf, Lebanon

Location

American University of Beirut Medical Center

Beirut, Lebanon

Location

Hotel Dieu de France

Beirut, Lebanon

Location

Centre Hospitalier Universitaire Notre Dame de Secours

Byblos, Lebanon

Location

Hammoud Hospital University Medical Center

Sidon, Lebanon

Location

The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Spaarne Gasthuis

Hoofddorp, 2134 TM, Netherlands

Location

MUMC

Maastricht, 6229 HX, Netherlands

Location

Maxima Medisch Centrum

Veldhoven, 5504 DB, Netherlands

Location

Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie; Oddzial Onkologii Klinicznej im. dr Ewy Pileckiej z pododdzialem

Bialystok, 15-027, Poland

Location

Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii Klinicznej, Oddzial Onkologii i Radioterapii

Gdynia, 81-519, Poland

Location

Mazowieckie Centrum Leczenia Chorób Pluc i Gruźlicy Oddzial III Chorób Pluc z Pododdzialem Onkologicznym

Otwock, 05-400, Poland

Location

Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. K.Marcinkowskiego w Poznaniu, Oddzial Chemioterapii

Poznan, 60-569, Poland

Location

Centro Clínico Champalimaud - Fundação Champalimaud

Lisbon, 1400-038, Portugal

Location

Centro Hospitalar Lisboa Norte, EPE- Hospital Pulido Valente

Lisbon, 1769-001, Portugal

Location

Centro Hospitalar do Porto, EPE - Hospital de Santo António

Porto, 4099-001, Portugal

Location

Hospital CUF Porto

Porto, 4100-180, Portugal

Location

Instituto Português de Oncologia do Porto Francisco Gentil, EPE

Porto, 4200-072, Portugal

Location

Centro Hospitalar de São João, EPE

Porto, 4200-319, Portugal

Location

SC Centrul de Oncologie Sf. Nectarie SRL, Departament Oncologie Medícala

Craiova, Dolj, 200347, Romania

Location

Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei"

Constanța, Judet Constanta, 900591, Romania

Location

SC Oncolab SRL

Craiova, Judet Dolj, 200385, Romania

Location

Spitalul Judetean de Urgenta "Dr. Constantin Opris", Sectia Oncologie Medicala

Baia Mare, Maramureş, 430031, Romania

Location

Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Departament Oncologie Medicala

Cluj-Napoca, 400015, Romania

Location

Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Dcpartamentul Oncologie Medicala

Cluj-Napoca, 400015, Romania

Location

Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Sectia Oncologic Medicala

Cluj-Napoca, 400015, Romania

Location

Hospital Universitari Germans Trias i Pujol ICO

Badalona, Barcelona, 08916, Spain

Location

Corporació Sanitaria Parc Taulí-Hospital de Sabadell

Sabadell, Barcelona, 08208, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitari Vall d' Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

MD Anderson Cancer Center Madrid

Madrid, 28033, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

Location

Complejo hospitalario regional virgen rocío

Seville, 41013, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Universitario La Fe de Valencia

Valencia, 46026, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

The Christie NHS Fundation Trust

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

The Clatterbridge Cancer Centre NHS Foundation Trust

Bebington, Wirral, CH63 4JY, United Kingdom

Location

Bristol Cancer Institute, UHB NHS Foundation Trust

Bristol, BS2 8ED, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

Location

Sarah Cannon Research Institute UK

London, W1G 6AD, United Kingdom

Location

Worcestershire Acute Hospitals NHS Trust

Worcester, WR5 1DO, United Kingdom

Location

Related Publications (1)

• Aix SP, Ciuleanu TE, Navarro A, Cousin S, Bonanno L, Smit EF, Chiappori A, Olmedo ME, Horvath I, Grohe C, Farago AF, Lopez-Vilarino JA, Cullell-Young M, Nieto A, Vasco N, Gomez J, Kahatt C, Zeaiter A, Carcereny E, Roubec J, Syrigos K, Lo G, Barneto I, Pope A, Sanchez A, Kattan J, Zarogoulidis K, Waller CF, Bischoff H, Juan-Vidal O, Reinmuth N, Domine M, Paz-Ares L. Combination lurbinectedin and doxorubicin versus physician's choice of chemotherapy in patients with relapsed small-cell lung cancer (ATLANTIS): a multicentre, randomised, open-label, phase 3 trial. Lancet Respir Med. 2023 Jan;11(1):74-86. doi: 10.1016/S2213-2600(22)00309-5. Epub 2022 Oct 14.

  PMID: 36252599 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

PM 01183; Doxorubicin; Cyclophosphamide; Vincristine; Topotecan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Camptothecin

Results Point of Contact

• Title: Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit.
• Organization: Pharma Mar S.A.

clinicaltrials@pharmamar.com

0034 918466000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: October 2, 2015
• Study Start: August 30, 2016
• Primary Completion: February 24, 2020
• Study Completion: February 24, 2020
• Last Updated: October 28, 2021
• Results First Posted: October 28, 2021

Record last verified: 2021-08

Locations

AR (5); CZ (2); AU (2); FR (7); HU (9); IT (9); US (29); GR (4); RO (7); NL (4); PL (4); ES (15); BU (4); PT (6); GB (6); LE (5); BE (6); DE (20); CA (6); BR (10)