A Phase 1b Trial in Patients With Renal Cell Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01258348
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : April 17, 2012
Information provided by (Responsible Party):
Eli Lilly and Company

December 8, 2010
December 10, 2010
April 17, 2012
July 2008
February 2012   (Final data collection date for primary outcome measure)
Recommended dose for Phase 2 studies of LY573636-sodium combined with Sunitinib in patients with metastatic Renal Cell Carcinoma [ Time Frame: Baseline to study completion ]
Same as current
Complete list of historical versions of study NCT01258348 on Archive Site
  • Pharmacokinetics, concentration maximum (Cmax) for LY573636-sodium [ Time Frame: Cycle 1 of treatment ]
  • Number of participants with tumor responses [ Time Frame: Baseline through study completion ]
  • Sunitinib pharmacokinetics in the presence of LY573636, area under the curve (AUC) [ Time Frame: Cycle 1 of treatment ]
  • Pharmacokinetics, area under the curve (AUC) for LY573636-sodium [ Time Frame: Cycle 1 of treatment ]
  • The number of participants with clinically significant effects [ Time Frame: Baseline to study completion ]
Same as current
Not Provided
Not Provided
A Phase 1b Trial in Patients With Renal Cell Cancer
A Phase 1b Study of LY573636-sodium in Combination With Sunitinib Malate in Patients With Metastatic Renal Cell Cancer
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.
Not Provided
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Renal Cell Cancer
  • Drug: Drug: LY573636-sodium

    Patient 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 patients enrolled after MTD will receive albumin-tailored doses.

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

    Other Name: Tasisulam
  • Drug: Sunitinib
    37.5 mg, administered orally, daily for 42 days (6 weeks). Patients may continue on treatment until clinical or objective disease progression.
Experimental: LY573636 +sunitinib
  • Drug: Drug: LY573636-sodium
  • Drug: Sunitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
February 2012
February 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have a histologically confirmed diagnosis of metastatic RCC
  • Patients must have received no prior treatment with a cytotoxic-based chemotherapy regimen
  • Patients 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 g/L
  • Patients with reproductive potential should use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drug
  • Exhibit patient 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). Patients 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 msec for males or greater than 470 msec for females
  • Have uncontrolled hypertension (greater than 150/100 mm Hg despite optimal medical therapy), or history of poor compliance with antihypertensive treatment
  • Patients with documented central nervous system or leptomeningeal metastasis (brain metastasis) at the time of study entry. Patients with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry
  • Patients with serious concomitant OR pre-existing disorders, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator)
  • Patients receiving warfarin therapy for treatment of venous thrombosis or other prothrombotic conditions
  • Patients with a second primary malignancy that could affect interpretation of the results. NOTE: Patients with adequately treated carcinoma of the skin (excluding melanoma) and patients with a prior history of malignancy who have been disease-free for greater than 2 years are eligible
  • Patients who have previously completed or withdrawn from this study or any other study investigating LY573636
  • Patients who have previously received sunitinib
  • Patients who are unable to swallow capsules
  • Patients who require concomitant use of potent CYP3A4 inducers or inhibitors
  • Women who are pregnant or lactating
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
H8K-MC-JZAI ( Other Identifier: Eli Lilly and Company )
Not Provided
Not Provided
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP