A Phase 1b Trial in Patients With Renal Cell Cancer

NCT ID: NCT01258348

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2012-02-29

Brief Summary

The purpose of this study is to determine a safe dose of LY573636-sodium to be given in combination with sunitinib to patients with metastatic Renal Cell Carcinoma (RCC) and to determine any side effects that may be associated with LY573636-sodium and sunitinib combination in this patient population. The tumor response rate will also be assessed.

Conditions

Metastatic Renal Cell Cancer

Study Design

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

Study Groups

LY573636 +sunitinib

Group Type: EXPERIMENTAL

Drug: LY573636-sodium

Intervention Type: DRUG

Participant specific dose based on height, weight and gender to target a specific exposure range, administered intravenously on Day 4 of a 42-day (6-week) cycle.

Dose will be escalated to reach the maximum tolerated dose (MTD). A cohort of participants enrolled after MTD will receive albumin-tailored doses.

Participants may continue on treatment until clinical or objective disease progression.

Sunitinib

Intervention Type: DRUG

37.5 or 50 milligrams (mg), administered orally, daily for a 42-day (6-week) cycle.

Participants may continue on treatment until clinical or objective disease progression.

Interventions

Drug: LY573636-sodium

Participant specific dose based on height, weight and gender to target a specific exposure range, administered intravenously on Day 4 of a 42-day (6-week) cycle.

Dose will be escalated to reach the maximum tolerated dose (MTD). A cohort of participants enrolled after MTD will receive albumin-tailored doses.

Participants may continue on treatment until clinical or objective disease progression.

Intervention Type: DRUG

Sunitinib

37.5 or 50 milligrams (mg), administered orally, daily for a 42-day (6-week) cycle.

Participants may continue on treatment until clinical or objective disease progression.

Intervention Type: DRUG

Other Intervention Names

Tasisulam

Eligibility Criteria

Inclusion Criteria

• Participants must have a histologically confirmed diagnosis of metastatic Renal Cell Carcinoma (RCC)
• Participants must have received no prior treatment with a cytotoxic-based chemotherapy regimen
• Participants must have measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
• Have adequate hematologic, hepatic and renal function
• Have a serum albumin level greater than equal to 3.0 grams/Liter (g/L)
• Participants with reproductive potential should use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drug
• Exhibit participant compliance and geographic proximity that allow for adequate follow-up
• Have given written informed consent approved by Lilly and the ethical review board (ERB)/institutional review board (IRB) governing the site
• Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy, for at least 4 weeks (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy (except alopecia). Participants who have received whole-brain radiation must wait 90 days before starting study therapy

Exclusion Criteria

• Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
• Have received a prior cytotoxic chemotherapy-based systemic therapy for metastatic RCC
• Have had any of the following within 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure (CHF), cerebrovascular accident, transient ischemic attack, or pulmonary embolism
• Ongoing cardiac arrhythmias greater than New York Health Association Class II (Protocol Attachment JZAI.4), atrial fibrillation of any grade, or prolongation of the QTc interval to greater than 450 milliseconds (msec) for males or greater than 470 msec for females
• Have uncontrolled hypertension [greater than 150/100 millimeters of mercury (mm Hg) despite optimal medical therapy], or history of poor compliance with antihypertensive treatment
• Participants with documented central nervous system or leptomeningeal metastasis (brain metastasis) at the time of study entry. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry
• Participants with serious concomitant OR pre-existing disorders, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator)
• Participants receiving warfarin therapy for treatment of venous thrombosis or other prothrombotic conditions
• Participants with a second primary malignancy that could affect interpretation of the results. NOTE: Participants with adequately treated carcinoma of the skin (excluding melanoma) and participants with a prior history of malignancy who have been disease-free for greater than 2 years are eligible
• Participants who have previously completed or withdrawn from this study or any other study investigating LY573636
• Participants who have previously received sunitinib
• Participants who are unable to swallow capsules
• Participants who require concomitant use of potent Cytochrome P450 3A4 (CYP3A4) inducers or inhibitors
• Women who are pregnant or lactating

• 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 1-317-615-4559 Mon -Fri 9AM - 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.

Indianapolis, Indiana, 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.

Greenville, South Carolina, 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.

The Woodlands, Texas, 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.

Norfolk, Virginia, 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.

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

H8K-MC-JZAI

Identifier Type: OTHER

Identifier Source: secondary_id

10407

Identifier Type: -

Identifier Source: org_study_id