TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer - Full Text View

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:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

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 ]

Estimated Enrollment:	2000
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493505

Contacts

Contact: Amgen Call Center

866-572-6436

Show 232 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

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:	June 12, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Primary Peritoneal Cancer

Additional relevant MeSH terms:

Ovarian Neoplasms
Peritoneal 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
Abdominal Neoplasms

Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 17, 2013