A Phase 1b Trial in Patients With Renal Cell Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01258348
First received: December 8, 2010
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Metastatic Renal Cell Cancer
Drug: Drug: LY573636-sodium
Drug: Sunitinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b Study of LY573636-sodium in Combination With Sunitinib Malate in Patients With Metastatic Renal Cell Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics, concentration maximum (Cmax) for LY573636-sodium [ Time Frame: Cycle 1 of treatment ] [ Designated as safety issue: No ]
  • Number of participants with tumor responses [ Time Frame: Baseline through study completion ] [ Designated as safety issue: No ]
  • Sunitinib pharmacokinetics in the presence of LY573636, area under the curve (AUC) [ Time Frame: Cycle 1 of treatment ] [ Designated as safety issue: No ]
  • Pharmacokinetics, area under the curve (AUC) for LY573636-sodium [ Time Frame: Cycle 1 of treatment ] [ Designated as safety issue: No ]
  • The number of participants with clinically significant effects [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: July 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY573636 +sunitinib 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01258348

Locations
United States, Indiana
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, 46219
United States, South Carolina
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, 29605
United States, Texas
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, 77380
United States, Virginia
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, 23502
Canada, Quebec
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, H3T 1E2
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01258348     History of Changes
Other Study ID Numbers: 10407, H8K-MC-JZAI
Study First Received: December 8, 2010
Last Updated: April 13, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014