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:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01493505
First received: September 29, 2011
Last updated: April 6, 2016
Last verified: April 2016
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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: | May 2020 |
| Primary Completion Date: | March 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 (Adult, Senior) |
| 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
Show 310 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493505
Show 310 Study Locations
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
| 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: | April 6, 2016 |
| 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:
|
Ovarian 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 Fallopian Tube Diseases Paclitaxel |
Trebananib Albumin-Bound Paclitaxel Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on September 30, 2016