TRINOVA-2: Trebananib in Ovarian Cancer-2

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01281254
First received: January 20, 2011
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS)

The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo plus PLD in women with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cancer
Drug: AMG386 plus PLD
Drug: Placebo plus PLD
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Doxorubicin (PLD) Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by progression-free survival, defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications [ Time Frame: Radiological imaging will be performed 8 weeks ± 1 week, starting from date of randomization for the first 64 weeks, then every 16 weeks ± 1 week for the next 32 weeks, and then every 24 weeks ± 4 weeks thereafter. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by overall survival [ Time Frame: weekly ] [ Designated as safety issue: No ]

Enrollment: 223
Study Start Date: March 2011
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo plus PLD
Arm B: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)
Drug: Placebo plus PLD

Pegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug.

PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)

Experimental: AMG386 plus PLD
Arm A: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)
Drug: AMG386 plus PLD
AMG 386 is a first in class investigational anti angiogenic drug that provides potent and selective inhibition of angiopoietins. AMG 386 is designed to inhibit angiogenesis by sequestering Ang1 and Ang2, thereby preventing their interaction with the Tie2 receptor. Pegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug. PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically documented invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Radiographically documented disease progression either on or following the last dose of the prior regimen for epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
  • Female 18 years of age or older at the time the written informed consent is obtained
  • Adequate organ and hematological function

Exclusion Criteria:

  • Subjects who have received more than 3 previous regimens of anti cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
  • Subjects treated with prior pegylated liposomal doxorubicin (PLD) or any anthracycline-based or mitoxantrone-based chemotherapy
  • Subjects with primary platinum-refractory disease
  • Subjects with platinum-free interval (PFI) > 12 months from their last platinum based therapy
  • History of central nervous system metastasis
  • Major surgery within 28 days prior to randomization or still recovering from prior surgery
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281254

  Show 106 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01281254     History of Changes
Other Study ID Numbers: 20060517, 2009-017946-30, ENGOT-ov-6, TRINOVA-2, 20060517
Study First Received: January 20, 2011
Last Updated: April 8, 2014
Health Authority: Australia: Austin Health Human Research Ethics Committee
Australia: Bellberry Human Research Ethics Committee
Australia: Hunter New England Human Research Ethics Committee
Australia: Melbourne Health Office for Research
Austria: Bundesamt für Sicherheit im Gesundheitswesen
Austria: Central Ethics Committee
Austria: Leitethikkommission der Medizinischen Universität Wien
Belgium: AZ Sint-Lucas Ethisch Comité
Belgium: Centre Hospitalier de l'Ardenne comité d'éthique
Belgium: Centre Hospitalier Régional de La Citadelle comité d'éthique
Belgium: Clinique Sainte Elisabeth comité d'éthique
Belgium: Commissie Medische Ethiek van de Universitaire Ziekenhuizen KULeuven
Belgium: Federal Agency for Medicines and Health ProductsBelgium: AZ Sint-Lucas Ethisch Comite
Belgium: Grand Hôpital de Charleroi comité d'éthique
Belgium: Jan Yperman ziekenhuis Ethisch Comité
Belgium: UZ Antwerpen Ethisch Comité
Canada: Health Canada
Denmark: Central Ethics Committee
Denmark: Danish Medicines Agency
Denmark: De Videnskabsetiske Komitéer for Region Hovedstaden (Ethics Committee for the Capital Region of Denmark)
Denmark: Laegemiddelstyrelsen
Denmark: Sundhedsstyrelsen (Danish Health and Medicines Authority)
France: Agence nationale de sécurité du médicament et des produits de santé (ANSM)
France: Central Ethics Committee: Comité de protection des personnes (CPP) Sud Est IV
Germany: Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM)
Germany: Bundesoberbehorde, BOB
Germany: Lead Ethics Committee: Ethic committee of the Nordrhein state medical board
Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe
Greece: National Ethics Committee
Greece: National Organization of Medicines
Hong Kong: Department of Health
Hungary: Central Ethics Committee
Hungary: National Institute of Pharmacy
Italy: Agenzia Italiana del Farmaco
Italy: COMITATO ETICO del Policlinico Universitario Agostino Gemelli
Italy: Local Ethics Committees
Italy: COMITATO ETICO DELL´ENTE OSPEDALIERO OSPEDALI GALLIERA DI GENOVA
Italy: Ministry of Health
Italy: The Istituto Superiore di Sanità (ISS) within the Italian National Health Service. Its activities include research, control, training and consultation in the interest of public health protection. Responsible to approved the phase 1 studies.
Latvia: Zāļu Klīniskās izpētes ētikas komiteja (Ethics Committee for Clinical trials of Medicinal products)
Latvia: Zāļu Valsts Agentūra (State Agency of Medicines)
Malaysia: National Pharmaceutical Control Bureau
New Zealand: Ethics Committee
New Zealand: Medicines and Medical Devices Safety Authority
Poland: Komisja Bioetyczna przy Okręgowej Izbie Lekarskiej w Białymstoku (Bioethics Committee for Medical Association)
Poland: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Singapore: Health Science Authority
Slovakia: Ethics Committees
Slovakia: Public Health Authority of the Slovak Republic
Slovakia: State Institiute for Drug Control
Slovakia: Local Ethics Committees
Slovakia: Ministry of Health
Slovakia: Štátny ústav pre kontrolu lieciv
Spain: Agencia Española de Medicamentos y Productos Sanitarios (AEMyPS)
Spain: Comité Ético de Investigación Clínica Hospital Universitario La Paz
Spain: Comité Ético de Investigación Clínica Hospital Arnau de Vilanova
Spain: Comité Ético de Investigación Clínica Hospital Clínico Univ. de Valencia
Spain: Comité Ético de Investigación Clínica Hospital Ramón y Cajal (for H. Ramón y Cajal and MD Anderson International)
Spain: Comité Ético de Investigación Clínica Parc de Salut Mar (Reference Ethic Committee)
Spain: Comité Ético de Investigación Hospital Clínico Universitario Virgen de la Victoria
South Korea: Korea Food & Drug Administration
Switzerland: Commission centrale d'éthique - Hôpitaux Universitaires de Genève
Switzerland: Kantonale Ethikkommission Aargau/Solothurn
Switzerland: Kantonale Ethikkommission Bern (KEK)
Switzerland: Kantonale Ethikkommission Zürich (KEK)
Switzerland: Swissmedic
Taiwan: Taiwan Food and Drug Administration
United Kingdom: Main Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
United States: Quorum Institutional Review Board

Keywords provided by Amgen:
Fallopian tube cancer
Primary peritoneal cancer
AMG386
Pegylated Liposomal Doxorubicin
Recurrent epithelial ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Doxorubicin
Liposomal doxorubicin
Trenananib
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014