Trial record 1 of 1 for:    NCT01493505
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TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01493505
First received: September 29, 2011
Last updated: September 19, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV 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: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Incidence of adverse events and significant laboratory abnormalities [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of AMG 386 (Cmax and Cmin) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    pre-dose weeks 1, 7, 10, 19 and within 10 minutes post dose week 1, 7

  • Incidence of anti-AMG 386 antibody formation [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    pre-dose weeks 1, 10, 19

  • Patient reported ovarian cancer-specific symptoms and health related quality of life [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Patient reported status as measured by the EuroQOL (EQ-5D) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • AMG 386 exposure-response relationships for PFS and OS [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Correlation of serum biomarkers with measures of response [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 1015
Study Start Date: January 2012
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Paclitaxel
Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
Drug: AMG 386 Placebo
AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)
Drug: Carboplatin
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)
Active Comparator: AMG 386 Drug: AMG 386
AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)
Drug: Paclitaxel
Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
Drug: Carboplatin
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)

  Eligibility

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

Inclusion Criteria:

  • Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded
  • Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
  • Subjects with FIGO Stage IIIC or IV disease must either:
  • Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or
  • Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer
  • ECOG performance status of 0 or 1
  • Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

  • Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
  • Previous abdominal and/or pelvic external beam radiotherapy
  • History of central nervous metastasis
  • History of arterial or venous thromboembolism within 12 months prior to randomization
  • Clinically significant cardiovascular disease within 12 months prior to randomization
  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: NCT01493505

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

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01493505     History of Changes
Other Study ID Numbers: 20101129, TRINOVA-3 20101129/ENGOT-ov2
Study First Received: September 29, 2011
Last Updated: September 19, 2014
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Amgen:
Primary Peritoneal Cancer

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
Carboplatin
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 October 29, 2014