Clinical trial NCT01214668: Dose-Escalation Study of LY573636-sodium and Liposomal Doxorubicin in Patients With Advanced Solid Tumors
Official title: A Phase 1b, Multicenter, Dose-Escalation Study of LY573636-sodium in Combination With Liposomal Doxorubicin in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Recommended Phase 2 Dose
timeFrame: Predose up to 28 days postdose in Cycle 1
Secondary outcomes:
measure: Number of Participants With Clinically Significant Events
timeFrame: Baseline to study completion up to 18.49 months
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY573636
timeFrame: Predose, 30 minutes (min), 2 hours (h), 4 h, 166 h, 360 h and 698 h postdose in Cycle 1; Predose, 30 min, 2 h, 4 h, 166 h, 360 h and 698 h postdose in Cycle 2; Predose, 166h, 360h and 698 h postdose in Cycle 3
measure: Number of Participants With Tumor Response
timeFrame: Baseline to measured progressive disease up to 4.7 months
measure: Pharmacokinetics: Area Under the Curve of LY573636 Above the Albumin Corrected Threshold (AUCalb)
timeFrame: Predose, 30 min, 2 h, 4 h, 166 h, 360 h and 698 h postdose in Cycle 1; Predose, 30 min, 2 h, 4 h, 166 h, 360 h and 698 h postdose in Cycle 2; Predose, 166h, 360h and 698 h postdose in Cycle 3
Other outcomes:
measure: Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment
timeFrame: From date of randomization until up to 30 days post study treatment discontinuation, assessed up to 4.7 months
Locations:
city: Scottsdale
country: United States
facility: 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.
state: Arizona
city: Encinitas
country: United States
facility: 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.
state: California
city: Oklahoma City
country: United States
facility: 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.
state: Oklahoma
city: Memphis
country: United States
facility: 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.
state: Tennessee
city: Seattle
country: United States
facility: 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.
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: