- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00721162
Study of Ramucirumab in Ovarian Cancer
September 10, 2019 updated by: Eli Lilly and Company
A Phase 2, Non-randomized, Open-label, Multicenter Study of IMC-1121B in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
The purpose of this study is to determine if ramucirumab given as monotherapy is effective in the treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Current chemotherapies used to treat ovarian cancer participants include doxorubicin, topotecan, and paclitaxel, to mention a few.
Doxorubicin was studied in ovarian cancer participants that were refractory to paclitaxel and platinum-based chemotherapy agents.
Inhibition of angiogenesis is considered a promising approach to the treatment of cancer.
Vascular endothelial growth factor (VEGF) is an important regulator of angiogenesis and is likely an important therapeutic target in persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
VEGF is overexpressed in ovarian tissue and may be the most important single tumor angiogenic factor.
Phase 1 studies currently nearing completion with ramucirumab have demonstrated safety and tolerability at clinically relevant doses, with preliminary evidence of clinical efficacy in ovarian cancer participants.
Therefore, ImClone Systems plans to conduct a Phase 2 trial to assess the safety and efficacy of ramucirumab in participants with platinum-refractory persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, SW3 6JJ
- ImClone Investigational Site
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Sutton, United Kingdom, SM2 5PT
- ImClone Investigational Site
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Florida
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Hollywood, Florida, United States, 33021
- ImClone Investigational Site
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Orlando, Florida, United States, 32806
- ImClone Investigational Site
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Illinois
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Chicago, Illinois, United States, 60637
- ImClone Investigational Site
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Louisiana
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Marrero, Louisiana, United States, 70072
- ImClone Investigational Site
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Metairie, Louisiana, United States, 70006
- ImClone Investigational Site
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Maryland
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Baltimore, Maryland, United States, 21237
- ImClone Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02114-2621
- ImClone Investigational Site
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Minnesota
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Rochester, Minnesota, United States, 55905
- ImClone Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- ImClone Investigational Site
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Texas
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Houston, Texas, United States, 77030-4009
- ImClone Investigational Site
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Washington
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Seattle, Washington, United States, 98104
- ImClone Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Each participant must meet the following criteria to be enrolled in this study:
- The participant has recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic documentation of the original primary tumor is required via a pathology report
- The participant has at least one unidimensional-measurable target lesion [≥ 2 centimeter (cm) with conventional techniques, or ≥ 1 cm by spiral computed tomography (CT) or magnetic resonance imaging (MRI)], as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Tumors within a previously irradiated field will be designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
- The participant has recovered to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v3.0) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies for ovarian cancer, with the exception of alopecia or peripheral neuropathy (which must have resolved to Grade ≤ 2). Any other prior therapy directed at the malignant tumor must be discontinued at least three weeks prior to the first dose of study medication, or hormonal therapy discontinued at least one week prior to the first dose of study medication. Continuation of hormone replacement therapy is permitted
- The participant has completed at least one platinum-based chemotherapeutic regimen for management of primary disease, and must have at least one of the following: a platinum-free interval of < 12 months after the final dose of primary platinum-based therapy, progression during platinum-based therapy, or persistent disease after platinum-based therapy
- The participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1 at study entry
- The participant has adequate hematological functions [absolute neutrophil count (ANC) ≥ 1200 cells/microliter (uL), hemoglobin ≥ 9 grams/deciliter (g/dL), and platelets ≥ 100,000 cells/uL]
- The participant has adequate hepatic function [bilirubin ≤ 1.5 times the upper limit of normal (ULN); aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 3.0 times ULN, or ≤ 5.0 times ULN if the transaminase elevation is due to liver metastases]
- The participant has adequate renal function [serum creatinine ≤ 1.5 x ULN or creatinine clearance (measured or calculated) ≥ 60 milliliters/minute (mL/min)]
- The participant's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicated ≥ 2+ proteinuria, then a 24-hour urine must be collected and must demonstrate < 1000 milligrams (mg) of protein in 24 hours to allow participation in the study
- The participant has adequate coagulation function, as defined by international normalized ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 1.5 X ULN if not receiving anticoagulation therapy. Participants on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin, and if on warfarin must have therapeutic INR and have no active bleeding (defined as within 14 days of first dose of study medication) or pathological condition that carries a high risk of bleeding (example, tumor involving major vessels or known varices)
- For participants who have received anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within normal institutional range by a pretreatment echocardiogram or multigated acquisition (MUGA) scan
- If sexually active, the participant is post-menopausal, surgically sterile, or using effective contraception in the opinion of the investigator
- The participant is ≥ 18 years of age
- The participant has a life expectancy of ≥ 3 months
- The participant is able to provide informed written consent and is amenable to compliance with protocol schedules and testing
Exclusion Criteria:
- The participant has a concurrent active malignancy, other than adequately treated nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm. A participant with previous history of malignancy is eligible provided that she has been disease-free for > 3 years
- The participant has received a noncytotoxic regimen (usually called targeted therapy such as bevacizumab) for recurrent or persistent disease. (Participants may have received a noncytotoxic regimen as primary treatment.)
- The participant has received radiotherapy for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within 3 weeks (21 days) prior to the first dose of study medication
- The participant has received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last 3 years. [Prior radiation for localized cancer (for example, of the breast, head and neck, or skin) is permitted, provided that it was completed > 3 years prior to the first dose of study medication, and the participant remains free of recurrent or metastatic disease.]
- The participant has received prior chemotherapy for any abdominal or pelvic tumor, other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer < 3 years prior to the first dose of study medication. Prior adjuvant chemotherapy for localized breast cancer is permitted, provided that it was completed >3 years prior to the first dose of study medication, and that the participant remains free of recurrent or metastatic disease
- The participant has undergone major abdominal surgery within 4 weeks (28 days) prior to first dose of study medication
- The participant has a suspected impending bowel obstruction, based on clinical or radiographic criteria
- The participant has received any hormonal therapy directed at the malignant tumor discontinued therapy within 1 week (7 days) prior to first dose of study medication
- The participant has received any other prior therapy directed at the malignant tumor, including immunologic agents, within 3 weeks (21 days) prior to first dose of study medication
- The participant has received previous treatment with ramucirumab
- The participant has participated in clinical trials of experimental agents within 4 weeks (28 days) prior to first dose of study medication
- The participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
- The participant has an ongoing or active infection requiring systemic antibiotics, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, myocardial infarction < 6 months, Grade ≥ 2 peripheral vascular disease, poorly controlled hypertension despite standard medical management poorly controlled thrombotic or hemorrhagic disorder, psychiatric illness or social situations that would limit compliance with study requirements, or any other serious uncontrolled medical disorders in the opinion of the investigator
- The participant has any history of brain metastases or leptomeningeal disease. Screening for central nervous system (CNS) involvement for testing asymptomatic participants is not required
- The participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
- The participant is pregnant [confirmed by serum beta human chorionic gonadotropin (β-HCG) test] or lactating
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Ramucirumab
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Participants will receive ramucirumab at 8 milligrams/kilogram (mg/kg) administered over 1 hour every other week (every 14 days).
Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Progression-Free Survival at 6 Months (PFS-6)
Time Frame: First Dose to 6 Months
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Data presented are the percentage of participants without progressive disease (PD) or death from any cause at 6 month after first dose.
PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0.
PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion.
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First Dose to 6 Months
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Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) and Partial Response (PR)
Time Frame: First dose to date of objective progressive disease /death or new anti-cancer therapy up to 34.6 months
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Objective response is confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0.
CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion.
ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression/recurrence or the start of new therapeutic anticancer treatment, whichever occurred first, divided by the total number of participants treated, then multiplied by 100.
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First dose to date of objective progressive disease /death or new anti-cancer therapy up to 34.6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Progression-Free Survival (PFS)
Time Frame: First dose to measured progressive disease or death due to any cause up to 34.6 months
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Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause.
PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0.
PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion.
For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.
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First dose to measured progressive disease or death due to any cause up to 34.6 months
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Overall Survival at 1 Year (OS-1)
Time Frame: First dose to 12 months
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Data presented are the percentage of participants surviving at least 12 months after first dose based on Kaplan Meier Method.
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First dose to 12 months
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Overall Survival (OS)
Time Frame: First dose to death due to any cause up to 43.9 months
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Overall survival is defined as the time from first dose to the date of death due to any cause.
For participants who were alive or were lost to follow-up, overall survival was censored on the last date the participant was known to be alive.
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First dose to death due to any cause up to 43.9 months
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Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events
Time Frame: First dose to 30 months
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Data presented are the number of participants who experienced treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or 4 TEAE, or adverse events (AE) leading to discontinuation of treatment that were considered to be related to ramucirumab.
A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.
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First dose to 30 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
July 21, 2008
First Submitted That Met QC Criteria
July 22, 2008
First Posted (Estimate)
July 23, 2008
Study Record Updates
Last Update Posted (Actual)
September 26, 2019
Last Update Submitted That Met QC Criteria
September 10, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Carcinoma
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Carcinoma, Ovarian Epithelial
- Antineoplastic Agents
- Ramucirumab
Other Study ID Numbers
- 13923
- 2007-006717-17 (EudraCT Number)
- CP12-0711 (Other Identifier: ImClone Systems)
- I4T-IE-JVBR (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
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