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TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01204749
First received: August 26, 2010
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cancer
Drug: AMG 386
Drug: AMG 386 Placebo
Drug: Paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: 8 Months on average ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 20 months on average ] [ Designated as safety issue: No ]
  • Objective Response Rate [ Time Frame: From Baseline (if subject has Measurable Disease) until objective response (radiologic) ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: From Baseline until progression ] [ Designated as safety issue: No ]
  • CA-125 response rate per Gynecologic Cancer Intergroup (GCIG) and change in CA-125 [ Time Frame: From Baseline until CA-125 response ] [ Designated as safety issue: No ]
  • Incidence of adverse events and significant laboratory abnormalities [ Time Frame: 8 Months on average ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of AMG 386 (Cmax and Cmin) [ Time Frame: Week 1 until week 9 of treatment ] [ Designated as safety issue: No ]
  • Incidence of the occurrence of anti-AMG 386 antibody formation [ Time Frame: Week 1 until maximum of 1-year following last dose of study drug ] [ Designated as safety issue: Yes ]
  • Patient reported Health Related Quality of Life (HRQOL) and ovarian cancer related symptoms using Functional Assessment of Cancer Therapy - Ovary questionnaire (FACT-O) [ Time Frame: From week 1 until 30-days following last study drug administration ] [ Designated as safety issue: No ]
  • Overall health status using EuroQOL(EQ-5D) [ Time Frame: From week 1 until 30-days following last study drug administration ] [ Designated as safety issue: No ]

Enrollment: 919
Study Start Date: October 2010
Estimated Study Completion Date: April 2017
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 386
AMG 386
Drug: AMG 386
Weekly Intravenous (IV) AMG 386 15 mg/kg
Drug: Paclitaxel
Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
Placebo Comparator: AMG 386 Placebo
AMG 386 placebo
Drug: AMG 386 Placebo
Weekly Intravenous (IV) placebo 15 mg/kg
Drug: Paclitaxel
Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)

  Eligibility

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

Inclusion Criteria:

  • Female 18 years of age or older at the time the written informed consent is obtained
  • Gynecologic Oncology Group (GOG) Performance Status of 0 or 1
  • Life expectancy >= 3 months (per investigator opinion)
  • Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (Subjects with pseudomyxoma , mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with borderline ovarian cancer, ie, subjects with low malignant potential tumors, and with clear cell or mucinous histology are excluded)
  • Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including at least a unilateral oophorectomy
  • Radiologically evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with modifications
  • Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapy administered after surgical or non-surgical assessment.
  • Adequate organ and hematological function
  • Generally well controlled blood pressure with systolic blood pressure <= 140 mmHg and diastolic blood pressure <= 90 mmHg prior to randomization. The use of anti-hypertensive medications to control hypertension is permitted
  • Radiographically documented disease progression either on or following the last dose of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer

Exclusion Criteria:

  • Subjects who have received more than 3 previous regimens of anti-cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancers
  • Subjects who have received paclitaxel as consolidation therapy, maintenance, or monotherapy are excluded
  • Subjects with primary platinum-refractory disease
  • Subjects with platinum-free interval (PFI) > 12 months from their last platinum based therapy
  • Radiotherapy <= 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities
  • Previous abdominal or pelvic radiotherapy
  • History of arterial or venous thromboembolism within 12 months prior to randomization
  • History of clinically significant bleeding within 6 months prior to randomization
  • History of central nervous system metastasis
  • Has not yet completed a 21 day washout period prior to randomization for any previous anti cancer systemic therapies (30 days for prior bevacizumab)
  • Enrolled in or has not yet completed at least 30 days (prior to randomization) since ending other investigational device or drug, or currently receiving other investigational treatments
  • Unresolved toxicities from prior systemic therapy that are Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 >= Grade 2 in severity except alopecia
  • Known active or ongoing infection (except uncomplicated urinary tract infection [UTI]) within 14 days prior to randomization
  • Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor
  • Treatment within 30 days prior to randomization with strong immune modulators including but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and lenalidomide
  • Clinically significant cardiovascular disease within 12 months prior to randomization
  • Major surgery within 28 days prior to randomization or still recovering from prior surgery
  • Minor surgical procedures, except placement of tunneled central venous access device within 3 days prior to randomization. Diagnostic laparoscopy is regarded as a minor surgical procedure.
  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: NCT01204749

  Show 225 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01204749     History of Changes
Other Study ID Numbers: 20090508
Study First Received: August 26, 2010
Last Updated: July 17, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Evaluation Center
Malaysia: National Pharmaceutical Control Bureau
Mexico: Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
Mexico: SSA (Secretaria de Salud Publica)
Peru: INS (Instituto Nacional de Salud)
Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED)
Romania: National Medicines Agency
Slovenia: Agency for Medicinal Products and Medicinal Devices of the Republic of Slovenia (ARSZMP)
South Korea: Korea Food and Drug Administration
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Switzerland: Swissmedic (Swiss Agency for Therapeutic Products)
United States: Food and Drug Administration
Australia: Therapeutic Goods Administration
Brazil: ANVISA (Agência Nacional de Vigilância Sanitária)
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Instituto De Salud Pública de Chile (ISP)
Japan: Ministry of Health, Labor and Welfare
Croatia: Ministarstvo zdravstva i socijalne skrbi (Ministry of Health and Social Welfare)
Czech Republic: Statni ustav pro kontrolu leciv
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Hong Kong: Department of Health
Latvia: State Agency of Medicines
France: Agence nationale de sécurité du médicament et des produits de santé (ANSM)
India: Central Drugs Standard Control Organization
Belgium: Federal Agency for Medicinal Products and Health Products
Greece: National Organization of Medicines
Italy: Agenzia Italiana del Farmaco (AIFA)
Poland: Office for Registration of Medicinal Products
South Africa: Medicines Control Council
Sweden: Medical Products Agency
Russia: The Ministry of Healthcare of the Russian Federation
Israel: Ministry of Health

Keywords provided by Amgen:
AMGEN
AMG 386
Angiogenesis Inhibitors
Fallopian Tube Cancer
Primary Peritoneal Cancer
Paclitaxel
Ovarian Cancer
TRINOVA-1

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014