Submitted by: N/A Last Updated by: James F. Ocampo 2017-05-12 13:16:39


MetMab Lung

PHRR140218-000176

YO28345

2013-CT0159

A Randomized, Phase III, multicenter, double-blind, placebo-controlled study evaluating the efficacy and safety of Onartuzumab (MetMAb) in combination with Erlotinib as second or third line treatment for patients with Met positive Incurable Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)

This is a randomized, Phase III, multicenter, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of onartuzumab in combination with erlotinib as compared with treatment with erlotinib alone in patients with incurable NSCLC identified to be Met positive.

Start Date Duration in Months Target Completion Date Actual Completion Date
2014-01-09 24 2016-01-09 0000-00-00

Terminated

study was cancelled in the Philippines

Institution Classification Region LTO #
Roche (Philippines), Inc. Private Business NCR CDRR-NCR-S-20
Institution Classification Region LTO #
Philippine General Hospital Government NCR
Vicente Sotto Memorial Medical Center Government Region VII
Lung Center of the Philippines Government NCR
Institution Region
F. Hoffmann-La Roche Ltd. Switzerland
Name E-Mail Phone Number Postal Address
James Ocampo james.ocampo@roche.com +6327187743 Unit 1804, One Global Place Bldg., 5th avenue cor. 25th street, Bonifacio Global City, Taguig City, Philippines
Name E-Mail Phone Number Postal Address
James Ocampo james.ocampo@roche.com +6327187743 Unit 1804, One Global Place Bldg., 5th avenue cor. 25th street, Bonifacio Global City, Taguig City, Philippines
Name Expertise Affiliation
Guia Elena Imelda R. Ladrera, MD Oncology Lung Center of the Philippines
Jennifer Sandoval-Tan, MD Oncology Philippine General Hospital
Manuel Legaspi III Oncology Vicente Sotto Memorial Medical Center
Project Location Institutional Ethics Review Board
Lung Center of the Philippines Lung Center of the Philippines Ethics Review Committee
Philippine General Hospital Philippine General Hospital Ethics Review Board
Vicente Sotto Memorial Medical Center Vicente Sotto Memorial Medical Center Ethics Committee

MET POSITIVE INCURABLE STAGE IIIB/IV NON-SMALL CELL LUNG CANCER (NSCLC)

• OS, defined as the time between date of randomization until death due to any cause The secondary efficacy outcome measures are as follows: • PFS, defined as the time from date of randomization to the date of first documented disease progression (assessed by the investigator based on RECIST v1.1) or death, whichever occurs first • ORR, defined as the percentage of patients who are judged by the investigator to have an objective response using RECIST v.1.1 • Health related quality of life (HRQOL), symptom severity, and health status of patients as measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) and the Lung Cancer Module (EORTC QLQ LC13) The safety outcome measures for this study are as follows: • Incidence, nature, and severity of AEs, including serious AEs • Changes in clinical laboratory results during and following study drug administration • Serum levels and incidence of ATAs against onartuzumab

The exploratory outcome measures for this study are as follows: • Duration of response (DOR), defined as the time from the first occurrence of a documented objective response to disease progression (as determined by the investigator using RECIST v1.1) or death from any cause during the study • Disease control rate (DCR) (rate of partial response plus complete response plus stable disease for at least 6 weeks), as determined by the investigator using RECIST v1.1

Terminated

  • Philippines

Clinical Trial

Unspecified

2014-01-22

None

INCLUSION CRITERIA Patients must meet the following criteria for study entry: • Signed, written informed consent prior to any study-specific screening procedure • Male or female, 18 years of age or older • Patients with ECOG performance status of 0–1 (see Appendix 3) • Histologically confirmed incurable Stage IIIB/IV NSCLC tumor • Met diagnosticpositive status ( 50% of tumor cells with membrane and/or cytoplasmic staining at moderate to high intensity) and results of EGFR activating mutation testing, as determined by the central laboratory Tumor tissue sample requirements are described in Section 4.5.1.11. An informed consent form is available under which a patient's archival tumor block or slides may be sent for central Met and EGFR testing while the patient is undergoing initial or first line therapy. • Radiographic evidence of disease (measurable disease not mandatory) The lesions must be outside a previous radiotherapy field if they are the sole site of disease, unless disease progression has been documented at that site since radiation. • Prior treatment with at least one platinum-based line of treatment for locally advanced, unresectable/inoperable disease or metastatic disease, and no more than one additional line of chemotherapy treatment Adjuvant/neoadjuvant chemotherapy or chemoradiation counts as a line of therapy if  12 months have elapsed between the last dose and the date of recurrence. Combined treatment with chemotherapy and radiation constitutes a single regimen; surgery is not considered a regimen. Maintenance therapy with a cytotoxic regimen that differs from first-line therapy is considered an additional line of therapy. However, a change of systemic regimen for reasons of intolerance or excessive toxicity does not constitute an additional regimen. The last dose of prior chemotherapy must have been administered  21 days prior to Day 1 ( 14 days for vinorelbine or other vinca alkaloids or gemcitabine). Anti-cancer agents used for pleurodesis are not counted as a line of therapy. Prior radiation therapy is allowed provided the patient has recovered from any toxic effects thereof and  7 days have elapsed between the last fraction and randomization (see separate criteria regarding brain or spinal cord metastases). EXCLUSION CRITERIA Patients who meet any of the following criteria will be excluded from study entry: Cancer Related Criteria • More than 30 days of exposure to an investigational or marketed agent that can act by EGFR inhibition, or a known EGFR-related toxicity resulting in dose modifications EGFR inhibitors include (but are not limited to) gefitinib, erlotinib, and cetuximab. • Prior exposure to agents targeting either the HGF or MET pathway, including but not limited to crizotinib, cabozantinib, ficlatuzumab, rilotumumab, and tivantinib • Pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently • Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression without evidence of clinically stable disease for  14 days Note: Patients with treated CNS metastases who are asymptomatic and on a stable dose of corticosteroids for  14 days prior to randomization are eligible. • History of another malignancy in the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other malignancies with an expected curative outcome • Life expectancy  12 weeks • Radiographically evident ILD, as evidenced by one or more of the following manifestations: interstitial pneumonia, pneumonitis, radiation pneumonitis, organizing pneumonia, pulmonary fibrosis, acute respiratory distress syndrome, lung infiltration, lung infection, or alveolitis, or a history of these conditions History of radiation pneumonitis in the radiation field (fibrosis) is permitted. Hematologic, Biochemical, and Organ Function • Granulocyte count  1.5  109/L, platelet count  100  109/L, or hemoglobin  9.0 g/dL. • AST (SGOT), ALT (SGPT), alkaline phosphatase (ALP)  2.5  upper limit of normal (ULN) • Total bilirubin  1.5  ULN • Albumin  25g/L • Uncontrolled hypercalcemia ( 1.5 mmol/L ionized calcium, or corrected serum calcium  ULN), or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy Patients who are receiving bisphosphonate therapy specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible. • Serum creatinine  1.5  ULN General • Significant history of cardiac disease (e.g., uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or cardiac ventricular arrhythmias requiring medication) • Serious active infection at the time of randomization or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment This includes patients known to be HIV-positive or patients with known active hepatitis B or C. • Any inflammatory changes of the surface of the eye (ophthalmologic examination not necessary) • Clinically significant gastrointestinal abnormalities, including uncontrolled inflammatory gastrointestinal diseases (Crohn’s disease, ulcerative colitis, etc.) • Inability to take oral medication, need for intravenous alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease • Pregnant or lactating women, or positive pregnancy test within 48 hours before starting study drug treatment • Women of childbearing potential ( 1 year amenorrheic) or sexually active males who are not employing adequate contraception (or practicing complete abstinence) Female patients of childbearing potential must commit to using a reliable and appropriate method of contraception until at least 3 months after the end of last dose of study treatment. Male patients with a partner of childbearing potential must agree to use a barrier method of contraception (condom) in addition to having their partner use another contraceptive method during the trial and for 3 months after the last dose of study treatment. Examples of reliable and appropriate methods of contraception include hormonal implants, oral contraceptives, intra-uterine devices, or a barrier method used in conjunction with spermicidal jelly. • Patients with uncontrolled diabetes mellitus, as evidenced by fasting serum glucose level  200 mg/dL • Any major surgery within 2 weeks prior to randomization • Inability to understand the local language(s) for which the EORTC QLQ C30 and QLQ LC13 questionnaires are available (see Appendix 5) • Any condition (e.g., psychological, geographical, etc.) that does not permit compliance with study and follow-up procedures Note: Patients who require oral anticoagulants (e.g., warfarin) are eligible provided there is increased vigilance with respect to the monitoring of INR. If medically appropriate and the treatment available, the investigator may also consider switching these patients to low-molecular-weight heparin, with which an interaction with onartuzumab or erlotinib is not expected.

Observational

Unspecified

Unspecified

Randomized

Double Blind

Unspecified

Parallel

The control group in this study will receive erlotinib, which is a widely used therapeutic option for patients with advanced NSCLC who have failed at least one platinum based chemotherapy. The safety of erlotinib is well documented. The combination of onartuzumab with erlotinib is not expected to have overlapping toxicity, based on the safety data collected in the Phase I and II onartuzumab clinical trials. A placebo control will be administered with erlotinib to avoid any observational or other potential bias in the assessment of both efficacy and safety of the study treatment. This control group will be instrumental in assessing the relative benefit or risk of adding onartuzumab to erlotinib.

Phase III

20

Unspecified

Unspecified

09 Jan 2014

Utilization Utilization Info
No records found.

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