Dose-Escalation Study of LY573636-sodium and Liposomal Doxorubicin in Patients With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Solid Tumors
In brief
The goal of this study is to determine the dose of LY573636-sodium (hereafter referred to as LY573636) that can be administered safely in combination with liposomal doxorubicin in patients with advanced cancer who have failed a prior treatment. The study consists of a dose escalation phase to the maximum tolerated dose (MTD) and a dose confirmation phase in patients with platinum resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have never been treated with doxorubicin.
Key facts
- Study ID
- NCT01214668
- Run by
- Eli Lilly and Company
- People needed
- 31
- Starts
- 2009-01-01
- Expected to finish
- 2012-02-01
- Last updated by the study team
- 2019-01-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- You must have a histologically confirmed solid malignancy that is unresectable and/or metastatic which has progressed after receiving standard approved chemotherapy
- You must have a solid malignancy for which an anthracycline-based regimen is felt to be a reasonable treatment option
- You must have measurable disease or non-measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
- You must have a serum albumin level greater than or equal to 3.0 grams/deciliter (g/dL) (30 g/L)
- You must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- You must have tumor progression after receiving standard/approved chemotherapy
- You must be reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures
- Women must be sterile, post-menopausal or on a contraception and men must be sterile or on contraception
- Your test results assessing the function of your blood, kidneys, liver, and heart are satisfactory
- Ovarian patients in the confirmation phase must have failed to achieve at least a partial response to a first-line platinum-based therapy (platinum-refractory) or have progression in less than 6 months after a response to a first-line platinum-based therapy (platinum-resistant)
- Ovarian patients in the confirmation phase must have measurable disease by RECIST
- Ovarian patients in the confirmation phase must be liposomal doxorubicin or doxorubicin naive and not amendable to curative therapy
You may not qualify if…
- You cannot have received other investigational drugs within the last 28 days
- You cannot have other on-going serious illnesses including active bacterial, fugal, or viral infections
- You cannot have current hematologic malignancies, acute or chronic leukemia, or brain metastasis
- You cannot currently be receiving warfarin (Coumadin®) therapy
- You cannot have known positive test results in human immunodeficiency, hepatitis B surface antigen or hepatitis C antibodies
- You cannot have a history of cardiac disease or clinical evidence of congestive heart failure
- Ovarian patients in the confirmation phase who have received 2 or more cytotoxic regimens for platinum-resistant disease
- You cannot currently be receiving amiodarone, quinidine, propofol, and clozapine
- If you are taking esomeprazole or pantoprazole you must be able to stop taking this medication within 72 hours before and after LY573636 administration
Where it is running
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Scottsdale, Arizona, United States
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Encinitas, California, United States
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Oklahoma City, Oklahoma, United States
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Memphis, Tennessee, United States
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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