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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 386 | Experimental | Arm A: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 15mg/kg IV QW |
|
| AMG 386 Placebo | Placebo Comparator | Arm B: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 Placebo IV QW |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 386 | Drug | Weekly Intravenous (IV) AMG 386 15 mg/kg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | 8 Months on average |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 20 months on average | |
| Objective Response Rate | From Baseline (if subject has Measurable Disease) until objective response (radiologic) | |
| Duration of response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85013 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24950985 | Background | Monk BJ, Poveda A, Vergote I, Raspagliesi F, Fujiwara K, Bae DS, Oaknin A, Ray-Coquard I, Provencher DM, Karlan BY, Lhomme C, Richardson G, Rincon DG, Coleman RL, Herzog TJ, Marth C, Brize A, Fabbro M, Redondo A, Bamias A, Tassoudji M, Navale L, Warner DJ, Oza AM. Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): a randomised, multicentre, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2014 Jul;15(8):799-808. doi: 10.1016/S1470-2045(14)70244-X. Epub 2014 Jun 17. | |
| 27546885 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| AMG 386 Placebo | Drug | Weekly Intravenous (IV) placebo 15 mg/kg |
|
|
| Paclitaxel | Drug | Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off) |
|
|
| Paclitaxel | Drug | Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off) |
|
|
| From Baseline until progression |
| CA-125 response rate per Gynecologic Cancer Intergroup (GCIG) and change in CA-125 | From Baseline until CA-125 response |
| Incidence of adverse events and significant laboratory abnormalities | 8 Months on average |
| Pharmacokinetics of AMG 386 (Cmax and Cmin) | Week 1 until week 9 of treatment |
| Incidence of the occurrence of anti-AMG 386 antibody formation | Week 1 until maximum of 1-year following last dose of study drug |
| Patient reported Health Related Quality of Life (HRQOL) and ovarian cancer related symptoms using Functional Assessment of Cancer Therapy - Ovary questionnaire (FACT-O) | From week 1 until 30-days following last study drug administration |
| Overall health status using EuroQOL(EQ-5D) | From week 1 until 30-days following last study drug administration |
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| Background |
| Monk BJ, Poveda A, Vergote I, Raspagliesi F, Fujiwara K, Bae DS, Oaknin A, Ray-Coquard I, Provencher DM, Karlan BY, Lhomme C, Richardson G, Rincon DG, Coleman RL, Marth C, Brize A, Fabbro M, Redondo A, Bamias A, Ma H, Vogl FD, Bach BA, Oza AM. Final results of a phase 3 study of trebananib plus weekly paclitaxel in recurrent ovarian cancer (TRINOVA-1): Long-term survival, impact of ascites, and progression-free survival-2. Gynecol Oncol. 2016 Oct;143(1):27-34. doi: 10.1016/j.ygyno.2016.07.112. Epub 2016 Aug 18. |
| 37185961 | Derived | Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3. |
| 27029706 | Derived | Fujiwara K, Monk BJ, Lhomme C, Coleman RL, Brize A, Oaknin A, Ray-Coquard I, Fabbro M, Provencher D, Bamias A, Vergote I, DeCensi A, Zhang K, Vogl FD, Bach BA, Raspagliesi F. Health-related quality of life in women with recurrent ovarian cancer receiving paclitaxel plus trebananib or placebo (TRINOVA-1). Ann Oncol. 2016 Jun;27(6):1006-1013. doi: 10.1093/annonc/mdw147. Epub 2016 Mar 30. |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C551398 | trebananib |
| D020533 | Angiogenesis Inhibitors |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043924 | Angiogenesis Modulating Agents |
| D006133 | Growth Substances |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D006131 | Growth Inhibitors |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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