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

NCT ID: NCT01214668

Last Updated: 2019-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-02-29

Brief 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.

Conditions

Solid Tumors

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LY573636 + Liposomal Doxorubicin

Group Type: EXPERIMENTAL

LY573636-sodium

Intervention Type: DRUG

Individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28-day cycle.

Participants may continue on study drug until disease progression, unacceptable toxicity, cumulative dose of 550 milligrams per square meter (mg/m²) of liposomal doxorubicin or doxorubicin is reached, or other withdrawal criterion is met.

Liposomal Doxorubicin

Intervention Type: DRUG

40 mg/m² on Day 1, given intravenously of each 28-day cycle

Participants may continue on study drug until disease progression, unacceptable toxicity, cumulative dose of 550 mg/m² of liposomal doxorubicin or doxorubicin is reached, or other withdrawal criterion are met.

Interventions

LY573636-sodium

Individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28-day cycle.

Participants may continue on study drug until disease progression, unacceptable toxicity, cumulative dose of 550 milligrams per square meter (mg/m²) of liposomal doxorubicin or doxorubicin is reached, or other withdrawal criterion is met.

Intervention Type: DRUG

Liposomal Doxorubicin

40 mg/m² on Day 1, given intravenously of each 28-day cycle

Participants may continue on study drug until disease progression, unacceptable toxicity, cumulative dose of 550 mg/m² of liposomal doxorubicin or doxorubicin is reached, or other withdrawal criterion are met.

Intervention Type: DRUG

Other Intervention Names

Tasisulam-sodium

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Countries

United States

Other Identifiers

H8K-MC-JZAN

Identifier Type: OTHER

Identifier Source: secondary_id

12887

Identifier Type: -

Identifier Source: org_study_id