Ovarian Cancer Clinical Trial

Dose-Escalation Study of LY573636-sodium and Liposomal Doxorubicin in Patients With Advanced Solid Tumors

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

31

Study ID:

NCT01214668

Recruitment Status:

Completed

Sponsor:

Eli Lilly and Company

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There are 5 Locations for this study

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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, 85258, 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, 92024, 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, 73104, 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, 38119, 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, 98195, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

31

Study ID:

NCT01214668

Recruitment Status:

Completed

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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