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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01214668
First received: October 1, 2010
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

The goal of this study is to determine the dose of 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.


Condition Intervention Phase
Solid Tumors
Drug: LY573636
Drug: Liposomal Doxorubicin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b, Multicenter, Dose-Escalation Study of LY573636-sodium in Combination With Liposomal Doxorubicin in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Recommended phase 2 dose [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with clinically significant events [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: Cycles 1 through 3 ] [ Designated as safety issue: No ]
  • Number of patients with tumor response [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
  • Pharmacokinetics, Area under the curve (AUC) [ Time Frame: Cycles 1 through 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY573636 + Liposomal Doxorubicin Drug: LY573636

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

Patients 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.

Other Name: Tasisulam
Drug: Liposomal Doxorubicin

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

Patients 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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214668

Locations
United States, Arizona
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, 85258
United States, California
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, 92024
United States, Oklahoma
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, 73104
United States, Tennessee
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, 38119
United States, Washington
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, 98195
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01214668     History of Changes
Other Study ID Numbers: 12887, H8K-MC-JZAN
Study First Received: October 1, 2010
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014