Ovarian NeoplasmsPhase 2NCT00718523
Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer
A Phase 2 study testing AMG 479 in people with Ovarian Neoplasms, run by Translational Research in Oncology at 55 sites in 8 countries.
Trial summary
This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary… 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?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 55 sitesin 8 countries
- Study dates
- Jan 2009to Nov 2014
- 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 optimally debulked (< 1 cm) FIGO stage III or stage IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
- Patients should have undergone surgical debulking, by a surgeon experienced in the management of ovarian cancer, with the aim of maximal surgical cytoreduction. All patients must be optimally debulked as defined as having no residual tumor of greater than 1 cm in the post surgical setting.
- Patients with stage IV disease will be eligible if a positive pleural cytology is the only extra peritoneal disease.
- Paraffin block (or 10 - 20 unstained slides) and fresh frozen surgical/biopsy specimens of the primary tumor are required at baseline.
- No prior systemic treatment in the primary disease treatment setting.
- Female ≥ 18 years of age or legal age.
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- ECOG performance status ≤ 2.
- Adequate organ and bone marrow function
- Non diabetic patients or Type 1 or 2 Diabetic Patients:
- Diabetes must be controlled with HgbA1c < 8% and fasting blood glucose level <160 mg/dL.
- Patient must be willing and able to comply with scheduled visits, and all study procedures.
- Informed consent obtained.
- Patients should be able to commence systemic therapy within 6 weeks of cytoreductive surgery.
- Life expectancy > 12 weeks.
- Adequate coagulation parameters (within 14 days prior to randomization), International Normalized Ratio (INR) ≤1.5; Activated Prothrombin Time (APTT) ≤ 1.5 x ULN
Who cannot join
- Non-epithelial ovarian cancer, including malignant mixed Mullerian tumors.
- Borderline tumors (tumors of low malignant potential).
- Planned intraperitoneal cytotoxic chemotherapy.
- Prior systemic anticancer therapy for ovarian cancer.
- Any previous radiotherapy to the abdomen or pelvis.
- Patients with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless ALL of the following criteria for describing the endometrial carcinoma are met: Stage ≤ Ib, no more than superficial myometrial invasion, no lymphovascular invasion, not poorly differentiated (i.e., not Grade 3 or papillary serous or clear cell).
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- Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri or curatively treated DCIS/LCIS, or non-melanoma or in situ melanoma skin cancer.
- Prior treatment with a humanized monoclonal antibody anticancer therapeutic.
- 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.
- Anticipation of a need for a major surgical procedure or radiation therapy during the study.
- History of hypersensitivity to recombinant proteins.
- Treatment with radiotherapy, surgery, or an investigational agent within 4 weeks of randomization.
- Any of the following within 6 months prior to study enrollment: 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, grade > 2 peripheral neuropathy, 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 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.
- Any other underlying physical or mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
- Refusal or inability to give informed consent to participate in the study.
- 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 study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
Trial locations and contacts
55 sites in 8 countries.
55 sites in 8 countries
United States23 sites
Central Hematology Oncology Medical Group Inc.
Alhambra, California, 91801
Hope A Women's Cancer Center
Asheville, North Carolina, 28806
Winship Cancer Institute Emory University School of Medicine
Atlanta, Georgia, 30322
Providence Saint Joseph Medical Center
Burbank, California, 91505
St Jude Heritage Healthcare
Fullerton, California, 92835
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052
Memorial Cancer Institute
Hollywood, Florida, 33021
Wilshire Oncology Medical Group Inc
La Verne, California, 91750
University of Southern California
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
UCLA
Los Angeles, California, 90095-1678
Hematology and Oncology Specialists, LLC
Metairie, Louisiana, 70006
Yale University School of Medicine
New Haven, Connecticut, 06510
North Valley Hematology/Oncology Medical Group
Northridge, California, 91325
Florida Hospital Cancer Institute
Orlando, Florida, 32804
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030
Mayo Clinic
Rochester, Minnesota, 55905
University of California San Francisco
San Francisco, California, 94115
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454
Moffitt Cancer Center
Tampa, Florida, 33612
The Toledo Hospital
Toledo, Ohio, 43606
University of Toledo
Toledo, Ohio, 43614
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27104
Germany9 sites
Charite Campus Benjamin Franklin
Berlin, 12200
University Hospital Charite
Berlin, 13353
Universitat Bonn
Bonn, 53105
Universitatsklinikum Erlangen
Erlangen, 91054
Universitatsklinikum Hamburg Eppendorf
Hamburg, 20246
Universitatsklinikum des Saarlandes
Homburg, 66421
Klinikum Kassel
Kassel, 34125
Rotkreuzkrankenhaus Munchen
Munich, 80637
Universitats Frauenklinik Tubingen
Tübingen, 72076
Israel5 sites
Meir Medical Center
Kfar Saba, 44281
Sheba Medical Center
Ramat Gan, 52621
Kaplan Medical Center
Rehovot, 76100
Sourasky Medical Center
Tel Aviv, 64239
Asaf Harofe MC
Zrifin, 70300
Spain5 sites
Hospital Clinic i Provincial
Barcelona, 08036
Hospital Universitario de Guadalajara
Guadalajara, 19002
Hospital U 12 de Octubre
Madrid, 28041
Hospital Universitario de Tenerife
San Cristóbal de La Laguna, 38320
Hospital Universitario Virgen Macarena de Sevilla
Seville, 341071
Canada4 sites
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2
London Health Science Center
London, Ontario, N6A4L6
CHUM Hopital Notre Dame
Montreal, Quebec, H2L4M1
Jewish General Hospital
Montreal, Quebec, H3T1E2
France4 sites
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, 85925
Centre Léon Bérard
Lyon, 69373
Clinique Hartmann
Neuilly-sur-Seine, 92200
Institut Curie
Paris, 75005
United Kingdom3 sites
Saint James's University Hospital
Leeds, LS97TF
University College London
London, W1T4TJ
Mount Vernon cancer centre
Northwood, HA62RN
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Multi-center, Phase II Study of Adding AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) to First Line Chemotherapy in Patients With Optimally Debulked ( < 1 cm ) Epithelial Ovarian Cancer
This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
- Conditions
- Ovarian Neoplasms
- Being tested
- AMG 479, AMG 479 Placebo
- 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 479Drug
Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
AMG 479 PlaceboDrug
Matching placebo administered Day 1 of each 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. Receives: Drug: AMG 479 Placebo |
| B | Experimental | AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle. Receives: Drug: AMG 479 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death.
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: Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle
Secondary outcomes (2)
Time To Progression (TTP): Interval From the Date of Randomization to the Date of Disease Progression
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: Radiological tumor assessment: every 12 (+/- 1) weeks for 3 years after randomization + CA125: day 1 of each cycle
Overall Survival (OS)
Interval between the date from randomization to death from any cause whichever came first.
Measured: Day 1 of each cycle up to 4 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startJan 2009
- Primary completionSep 2013
- Study completionNov 2014
Why it stopped: The steering committee of the TRIO014 study has taken the decision to stop the TRIO014 trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research in Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gottfried E Konecny, MD, Study chair, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718523
- Sponsor's protocol ID
- TRIO 014
- Status last verified
- Dec 2015
- First submitted
- 17 Jul 2008
- Last updated
- 12 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Multi-center, Phase II Study of Adding AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) to First Line Chemotherapy in Patients With Optimally Debulked ( < 1 cm ) Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00718523
- Acronym / sponsor ID
- TRIO 014
- Conditions
- Ovarian Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The steering committee of the TRIO014 study has taken the decision to stop the TRIO014 trial.
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Translational Research in OncologyUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 18 Jul 2008 (estimated)
- Results
- Posted 12 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: AMG 479 PlaceboPlacebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. |
| B | Experimental | Drug: AMG 479AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically-confirmed optimally debulked (< 1 cm) FIGO stage III or stage IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
- Patients should have undergone surgical debulking, by a surgeon experienced in the management of ovarian cancer, with the aim of maximal surgical cytoreduction. All patients must be optimally debulked as defined as having no residual tumor of greater than 1 cm in the post surgical setting.
- Patients with stage IV disease will be eligible if a positive pleural cytology is the only extra peritoneal disease.
- Paraffin block (or 10 - 20 unstained slides) and fresh frozen surgical/biopsy specimens of the primary tumor are required at baseline.
- No prior systemic treatment in the primary disease treatment setting.
Key exclusion criteria (22 listed)
- Non-epithelial ovarian cancer, including malignant mixed Mullerian tumors.
- Borderline tumors (tumors of low malignant potential).
- Planned intraperitoneal cytotoxic chemotherapy.
- Prior systemic anticancer therapy for ovarian cancer.
- Any previous radiotherapy to the abdomen or pelvis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 479Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle | Drug | B |
| AMG 479 PlaceboMatching placebo administered Day 1 of each 21 day cycle. | Drug | A |
Primary outcome
Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death.
Time frame: Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle
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
2 secondary outcomes
Time To Progression (TTP): Interval From the Date of Randomization to the Date of Disease Progression
Time frame: Radiological tumor assessment: every 12 (+/- 1) weeks for 3 years after randomization + CA125: day 1 of each cycle
Overall Survival (OS)
Time frame: Day 1 of each cycle up to 4 years after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gottfried E Konecny, MD study chair
University of California, Los Angeles
55 sites in 8 countries: see every site and its status.
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 55 sites in 8 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 15 inclusion and 22 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: stopped early, as of the sponsor's last update on 12 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 55 sites in United States, Germany, Israel, Spain, Canada and 3 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. Some participants in this study may receive a placebo. 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 12 Jan 2016). 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?
Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death. (time frame: Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2016.