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Ovarian NeoplasmsPhase 2NCT00719212

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

A Phase 2 study testing AMG 479 in people with Ovarian Neoplasms, run by Translational Research in Oncology at 37 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Neoplasms
What is being tested?
AMG 479
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
37 sitesin 7 countries
Study dates
Jan 2009to May 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE v.3.0 Grade ≤ 1 and to baseline laboratory values as defined in the inclusion criterion immediately below.
  • 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.

Who cannot join

  • 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.
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  • 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.
  • Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the trial.
  • Refusal or inability to give informed consent to participate in the trial.
  • Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of trial results, and in the judgment of the investigator would make the patient inappropriate for entry into this trial.

Trial locations and contacts

37 sites in 7 countries.

37 sites in 7 countries

United States16 sites

  • St Joseph Mercy Health System

    Ann Arbor, Michigan, 48106

  • University of Colorado

    Aurora, Colorado, 80045

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • University of Chicago

    Chicago, Illinois, 60637

  • St Jude Heritage Healthcare

    Fullerton, California, 92835

  • Comprehensive Cancer Centre of Nevada

    Henderson, Nevada, 89052

  • Wilshire Oncology Medical Group Inc

    La Verne, California, 91750

  • LAC/USC Medical Center

    Los Angeles, California, 90033

  • University of Southern California/ Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • UCLA

    Los Angeles, California, 90095-1678

  • North Valley Hematology/ Oncology Medical Group

    Northridge, California, 91325

  • Ventura County Hematology Oncology Specialists

    Oxnard, California, 93030

  • Central Hematology Oncology Medical Group Inc.

    Pasadena, California, 91107

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

Other trials in United States

France5 sites

  • Centre Hospitalier Départemental Les Oudairies

    La Roche-sur-Yon, 85295

  • Centre Léon Berard

    Lyon, 69373

  • Clinique Hartmann

    Neuilly-sur-Seine, 92

  • Institut Curie

    Paris, 75005

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Ireland5 sites

  • Cork University Hospital

    Cork

  • Mater Misericordiae University Hospital

    Dublin

  • Mater Private Hospital

    Dublin

  • St Jame's Hospital

    Dublin

  • Waterford Regional Hospital

    Waterford

Other trials in Ireland

Canada4 sites

  • Tom Baker Centre

    Calgary, AB T2N 4N2

  • Juravinski Cancer Center

    Hamilton, ON L8S1B7

  • CHUM Hôpital Notre Dama

    Montreal, H2W 1Y5

  • Jewish General Hospital

    Montreal, H3G 1 E2

Other trials in Canada

Germany3 sites

  • Charité Campus Benjamin Franklin

    Berlin, 12200

  • Universitatsklinikum Erlangen

    Erlangen, 91054

  • Universitatsklinikum Hamburg Eppendorf

    Hamburg, 20246

Other trials in Germany

Spain3 sites

  • Hospital Universitario de Tenerife

    La Laguna (Santa Cruz de Tenerife), 38320

  • Hospital U 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Virgen Macarena de Sevilla

    Seville, 341071

Other trials in Spain

Israel1 site

  • Kaplan Medical Center

    Rehovot, 76100

Other trials in Israel

About this study

Official title: A Multicenter Open Label Phase II Study of the Efficacy and Safety of AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) as Second Line Therapy in Patients With Recurrent Platinum Sensitive Ovarian Cancer

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.

Being tested
AMG 479
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMG 479Biological

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

Study groups in NCT00719212
Study groupRoleWhat they receive
AMG 479ExperimentalAMG 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.
Receives: Biological: AMG 479

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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

  2. 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

    Measured: 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)

  1. Time To Progression (TTP) Investigator Assessment

    Interval from the date of registration to the date of disease progression Investigator assessment As per RECIST (v1.0), disease progression represented an increase of at least 20% in the sum of the longest diameter (SLD) of target lesions, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

    Measured: 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

  2. 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

    RECIST(v1.0):

    • CR:disappearance of all target les°\&non-target les°\&normalization of tumor marker level
    • PR:at least 30% decrease in the sum of the LD of target les°-ref the baseline sum LD OR CR for target les°\&incomplete resp/SD for non target les°
    • SD:insufficient shrinkage for PR or increase for PD-ref the smallest sum LD since ttmt started or Persistence of one/more non-target les°or/\&maintenance of tumor marker level above the normal

    CA125 level:

    • PR:elev of CA125 at baseline PR if a ≥ 50% decrease compared to baseline value observed on 2 consec assessmts drawn at least 1 wk apart
    • CR:elev of CA125 at baseline CR 2 CA125 below ULN observed on 2 consec assessmts drawn at least 1 wk apart
    • SD:neither CR/PR nor PD

    Best overall resp of :

    • CR:if CR per RECIST \& per CA125
    • PR:if CR per RECIST \& PR per CA125 OR CR per RECIST and SD per CA125 with elev CA125 at baseline OR PR per RECIST \& CR/PR or SD per CA125
    • SD:other cases not qualifying for progression-at least 24 wks

    Measured: At 16 weeks from registration

  3. Overall Survival (OS) Investigator Assessment

    Interval between the date of registration and the date of death

    Measured: 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

  4. 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.

    The GCIG criteria (November 2005) were used to define progressive disease, based on serum CA 125 levels, as follows:

    • Patients with elevated CA 125 pretreatment and normalization of CA 125 needed to show evidence of CA 125 greater than, or equal to, two times the ULN on two occasions at least 1 week apart or
    • Patients with elevated CA 125 pretreatment, which never normalizes needed to show evidence of CA 125 greater than, or equal to, two times the nadir value on two occasions at least 1 week apart or
    • Patients with CA 125 in the normal range pretreatment needed to show evidence of CA 125 greater than, or equal to, two times the ULN on two occasions at least 1 week apart.

    Measured: Day 1 of each cycle

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

    A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:

    • Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR
    • Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR
    • CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2008 (estimated)
  2. Study startJan 2009
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00719212
Sponsor's protocol ID
TRIO 015
Status last verified
Dec 2015
First submitted
18 Jul 2008
Last updated
11 Jan 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMG 479 in people with Ovarian Neoplasms, run by Translational Research in Oncology at 37 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, France, Ireland, Canada, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00719212.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.

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