Study of Ramucirumab (IMC-1121B) Therapy and Corrected QT (QTc) Interval Changes (NCT01017731) | Clinical Trial Compass
CompletedPhase 2
Study of Ramucirumab (IMC-1121B) Therapy and Corrected QT (QTc) Interval Changes
United States68 participantsStarted 2009-11
Plain-language summary
The purpose of this study is to determine if Ramucirumab (IMC-1121B) causes prolongation of the QT/QTc interval in participants with advanced cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The participant has histologically documented advanced or metastatic malignant cancer of solid tumor origin which has not responded to standard therapy or for which no standard therapy is available
* The participant has resolution of adverse events from prior anticancer therapies
* Performance status of 0 to 2
* The participant is ≥ 18 years of age
* The participant is able to provide informed written consent and is amenable to compliance with protocol schedules and testing
* The participant has adequate liver, kidney, blood, and blood clotting functions as defined in trial entrance criteria
* The participant agrees to use adequate contraception during the study period and for 8 weeks after the last dose of study treatment
Exclusion Criteria:
* The participant had anticancer therapy within 14 days (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
* The participant had therapeutic radiotherapy within 14 days prior to entering the study
* The participant has ongoing side effects ≥ Grade 2 due to prior anticancer therapy
* The participant has brain or leptomeningeal metastases
* The participant has a history of uncontrolled or severe cardiac disease
* The participant has a history of severe congestive heart failure (CHF)
* The participant has a known history of arterial thrombotic events
* The participant has a known history of significant peripheral arterial disease (PAD)
* The participant has an implantable pacemaker or automatic im…
What they're measuring
1
Change From Baseline to Cycle 3 in QT/Corrected QT (QTc) Interval Prolongation in Participants