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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01214668 |
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Date of registration:
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01/10/2010 |
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Primary sponsor: |
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Public title:
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Dose-Escalation Study of LY573636-sodium and Liposomal Doxorubicin in Patients With Advanced Solid Tumors
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Scientific title:
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A Phase 1b, Multicenter, Dose-Escalation Study of LY573636-sodium in Combination With Liposomal Doxorubicin in Patients With Advanced Solid Tumors |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01214668 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Call 1-877-CTLILLY (1-877-285-4559) or 317-651-4559 Mon. - Fri. 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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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 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Solid Tumors
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Intervention(s)
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Drug: Liposomal Doxorubicin
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Drug: LY573636
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Primary Outcome(s)
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Recommended phase 2 dose
[Time Frame: Baseline to study completion]
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Secondary Outcome(s)
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Number of participants with clinically significant events
[Time Frame: Baseline to study completion]
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Number of patients with tumor response
[Time Frame: Baseline to study completion]
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Pharmacokinetics, Area under the curve (AUC)
[Time Frame: Cycles 1 through 3]
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Pharmacokinetics, maximum concentration (Cmax)
[Time Frame: Cycles 1 through 3]
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Secondary ID(s)
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12887
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H8K-MC-JZAN
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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