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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

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ClinicalTrials.gov Identifier: NCT01204749
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cancer Drug: AMG 386 Drug: AMG 386 Placebo Drug: Paclitaxel Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 919 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Paclitaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: AMG 386
Arm A: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 15mg/kg IV QW
 Drug: AMG 386
Weekly Intravenous (IV) AMG 386 15 mg/kg
Other Name: Angiogenesis inhibitor

Drug: Paclitaxel
Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
Other Name: Taxol USPI, 2007; Taxol SPC, 2009
Placebo Comparator: AMG 386 Placebo
Arm B: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 Placebo IV QW
 Drug: AMG 386 Placebo
Weekly Intravenous (IV) placebo 15 mg/kg
Other Name: Placebo comparator

Drug: Paclitaxel
Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
Other Name: Taxol USPI, 2007; Taxol SPC, 2009


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 8 Months on average ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 20 months on average ]
  2. Objective Response Rate [ Time Frame: From Baseline (if subject has Measurable Disease) until objective response (radiologic) ]
  3. Duration of response [ Time Frame: From Baseline until progression ]
  4. CA-125 response rate per Gynecologic Cancer Intergroup (GCIG) and change in CA-125 [ Time Frame: From Baseline until CA-125 response ]
  5. Incidence of adverse events and significant laboratory abnormalities [ Time Frame: 8 Months on average ]
  6. Pharmacokinetics of AMG 386 (Cmax and Cmin) [ Time Frame: Week 1 until week 9 of treatment ]
  7. 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 ]
  8. 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 ]
  9. Overall health status using EuroQOL(EQ-5D) [ Time Frame: From week 1 until 30-days following last study drug administration ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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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): NCT01204749


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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01204749    
Other Study ID Numbers: 20090508
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016
Keywords provided by Amgen:
AMGEN
AMG 386
Angiogenesis Inhibitors
Fallopian Tube Cancer
 Primary Peritoneal Cancer
Paclitaxel
Ovarian Cancer
TRINOVA-1
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Trebananib
Angiogenesis Inhibitors
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators