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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

A Phase 1b, Multicenter, Dose-Escalation Study of LY573636-sodium in Combination With Liposomal Doxorubicin in Patients With Advanced Solid Tumors


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended phase 2 dose

Outcome Time Frame:

Baseline to study completion

Safety Issue:

Yes

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

12887

NCT ID:

NCT01214668

Start Date:

January 2009

Completion Date:

February 2012

Related Keywords:

  • Solid Tumors
  • Neoplasms

Name

Location

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. Phoenix, Arizona  85012
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. Greenbrae, California  94904
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. Tulsa, Oklahoma  74136
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  38138
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  98133