Study of AMG 479 as Second Line Therapy in Patients With Recurrent Platinum-sensitive Ovarian Cancer

NCT00719212 | Completed Phase 2 Results DMC

• 1 other identifier: TRIO 015
• Study Type: interventional
• Target: 61
• Locations: 7 countries
• Sites: 37

Brief Summary

The purpose of this study is to obtain an estimate of the objective response rate (ORR) of AMG 479 in patients with recurrent platinum-sensitive ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma failing frontline chemotherapy.

Conditions

Ovarian Neoplasms

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR) Investigator Assessment: % of Patients in the Group Who Achieve a Complete Response(CR) or Partial Response(PR) According to RECIST Criteria and GCIG CA125 Response Criteria. - Assessments of the Response by the Investigators

  RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions \& normalization of tumor marker level/•PR:at least 30% decrease in the sum of the longest diam(LD) of target les° taking as ref the baseline sum LD OR CR for target les° \& incomplete response/SD for nontarget les°. CR \& PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria: * PR:elevated CA125 at baseline PR considered if a ≥ 50% decrease compared to baseline value was observed on 2 consecutive assessmts drawn at least 1 wk apart * CR:elevated CA125 at baseline CR was def with 2 CA125 values below ULN observed on 2 consecutive assessmts drawn at least 1 wk apart A pt was considered to have a best overall resp of:CR:if CR as per RECIST \& CA125 /-PR: if CR as per RECIST \& PR as per CA125 OR CR as per RECIST and SD as per CA125 with elevated CA125 at baseline OR PR as per RECIST \& CR/PR or SD as per CA125

  Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle

• Objective Response Rate (ORR) Independent Radiology Committee % of Patients in the Group Who Achieve a Complete or Partial Response According to RECIST Criteria and GCIG CA 125 Response Criteria.

  RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions \& normalization of tumor marker level/•PR:at least 30% decrease in the sum of the longest diam(LD) of target les° taking as ref the baseline sum LD OR CR for target les° \& incomplete response/SD for nontarget les°. CR \& PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria: * PR:elevated CA125 at baseline PR considered if a ≥ 50% decrease compared to baseline value was observed on 2 consecutive assessmts drawn at least 1 wk apart * CR:elevated CA125 at baseline CR was def with 2 CA125 values below ULN observed on 2 consecutive assessmts drawn at least 1 wk apart A pt was considered to have a best overall resp of:CR:if CR as per RECIST \& CA125 /-PR: if CR as per RECIST \& PR as per CA125 OR CR as per RECIST and SD as per CA125 with elevated CA125 at baseline OR PR as per RECIST \& CR/PR or SD as per CA125

  Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle

Secondary Outcomes (5)

• Time To Progression (TTP) Investigator Assessment

  Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response

• Clinical Benefit Rate (CBR) Investigator Assessmt % of Patients in the gp Who Achieve a Complete Response-CR,Partial Response-PR or Stable Disease-SD for 16wks From Registrat° Considering the Global Response Combining RECIST Criteria and CA125 Assessmts

  At 16 weeks from registration

• Overall Survival (OS) Investigator Assessment

  Day 1 of each cycle during study treatment + follow-up every 6 months for the first 3 years in the study or until death whichever occurs first

• Time To Marker Progression (TTMP) Investigator Assessment - Interval Form the Date of Registration to the Date of Disease Progression as Per GCIG 2005 Definition of CA 125 Progression.

  Day 1 of each cycle

• Progression-free Survival (PFS) Investigator Assessment - Interval From Registration to Disease Progression or Death Due to Any Cause - According to RECIST and CA 125

  Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response

Study Arms (1)

AMG 479

EXPERIMENTAL

AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.

Biological: AMG 479

Interventions

AMG 479 BIOLOGICAL

Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle

AMG 479

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically-confirmed ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma. Baseline paraffin embedded tissue from the patient's primary diagnosis is requested before study enrollment and should be forwarded to the designated central laboratory. In patients with measurable disease or sufficient ascites, fresh frozen tissue or ascites fluid should be obtained by needle biopsy and submitted to the designated central laboratory.
• Prior treatment with at most 1 treatment regimen in the primary treatment setting.
• Platinum-sensitive disease defined by recurrence or progression of disease \> 6 months AND \< 24 months after completion of prior platinum based chemotherapy.
• Female \> 18 years of age or legal age.
• ECOG performance status ≤ 1.
• Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Subjects with non-measurable disease with a biochemical recurrence are eligible provided the CA 125 is elevated by more than 2 times the upper limits of normal, confirmed in two successive samples, drawn at least one week apart.
• Adequate organ and bone marrow function
• Nondiabetic patients or Type 1 or 2 Diabetic Patients controlled with HgbA1c \< 8% and fasting blood glucose level \<160 mg/dL
• Adequate coagulation parameters (within 21 days prior to registration), International Normalized Ratio (INR) ≤1.5; Activated ProThrombin Time (APTT) ≤ 1.5 x ULN.

You may not qualify if:

• More than 1 prior chemotherapy regimen in the treatment of ovarian cancer.
• Platinum-resistant disease as defined by a recurrence or progression less or equal to six months after completion of the frontline platinum based chemotherapy.
• Anticipation of a need for a major surgical procedure (e.g., impending bowel obstruction, gastrointestinal perforation) or radiation therapy during the trial.
• Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri.
• Prior treatment with investigational treatment targeted to IGF axis including, but not limited to, CP 751,871, IM-A12, RO4858696.
• Previous exposure to AMG 479.
• History of hypersensitivity to recombinant proteins.
• Prior treatment with a humanized monoclonal antibody.
• Treatment with chemotherapy, radiotherapy, surgery, blood products, or an investigational agent within 3 weeks of trial enrolment.
• Any of the following within 6 months prior to trial registration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
• History of brain metastases, spinal cord compression, or carcinomatous meningitis.
• Patient of child-bearing potential is evidently pregnant (eg, positive human chorionic gonadotropin test) or is breast feeding.
• Patient of child-bearing potential is not willing to use adequate contraceptive precautions.
• Known active infection, or on antiretroviral therapy for HIV disease.
• Known positive test for chronic hepatitis B or C infection.

Sponsors & Collaborators

• Translational Research in Oncology: lead

Study Sites (37)

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

St Jude Heritage Healthcare

Fullerton, California, 92835, United States

Location

Wilshire Oncology Medical Group Inc

La Verne, California, 91750, United States

Location

LAC/USC Medical Center

Los Angeles, California, 90033, United States

Location

University of Southern California/ Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

UCLA

Los Angeles, California, 90095-1678, United States

Location

North Valley Hematology/ Oncology Medical Group

Northridge, California, 91325, United States

Location

Ventura County Hematology Oncology Specialists

Oxnard, California, 93030, United States

Location

Central Hematology Oncology Medical Group Inc.

Pasadena, California, 91107, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Cancer Center of Kansas

Wichita, Kansas, 67214, United States

Location

St Joseph Mercy Health System

Ann Arbor, Michigan, 48106, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Comprehensive Cancer Centre of Nevada

Henderson, Nevada, 89052, United States

Location

Tom Baker Centre

Calgary, AB T2N 4N2, Canada

Location

Juravinski Cancer Center

Hamilton, ON L8S1B7, Canada

Location

CHUM Hôpital Notre Dama

Montreal, H2W 1Y5, Canada

Location

Jewish General Hospital

Montreal, H3G 1 E2, Canada

Location

Centre Hospitalier Départemental Les Oudairies

La Roche-sur-Yon, 85295, France

Location

Centre Léon Berard

Lyon, 69373, France

Location

Clinique Hartmann

Neuilly-sur-Seine, 92, France

Location

Institut Curie

Paris, 75005, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Charité Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Universitatsklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitatsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Cork University Hospital

Cork, Ireland

Location

Mater Misericordiae University Hospital

Dublin, Ireland

Location

Mater Private Hospital

Dublin, Ireland

Location

St Jame's Hospital

Dublin, Ireland

Location

Waterford Regional Hospital

Waterford, Ireland

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Hospital Universitario de Tenerife

La Laguna (Santa Cruz de Tenerife), 38320, Spain

Location

Hospital U 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Virgen Macarena de Sevilla

Seville, 341071, Spain

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

ganitumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Matthieu Rupin
• Organization: Translational Research In Oncology (formerly CIRG)

matthieu.rupin@trioncology.org

+33 (1) 58 10 08 89

Study Officials

• Gottfried E Konecny, MD

  University of California, Los Angeles

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 21, 2008
• Study Start: January 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 11, 2016
• Results First Posted: December 1, 2015

Record last verified: 2015-12

Locations

FR (5); DE (3); IL (1); US (16); ES (3); IE (5); CA (4)