A Safety Study in Patients With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01284335
First received: January 19, 2011
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to determine a safe dose of LY573636-sodium when used in 5 separate combinations with an approved cancer medication for treating patients with advanced cancer. Data from this study will be reviewed for any side effects or anti-tumor activity that may be associated with the LY573636-sodium combination treatments.


Condition Intervention Phase
Advanced Solid Tumors
Drug: Gemcitabine
Drug: Docetaxel
Drug: Temozolomide
Drug: Cisplatin
Drug: Erlotinib
Drug: LY573636
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Multicenter, Dose-escalation Study of LY573636-Sodium in Combination With 1) Gemcitabine HCl or 2) Docetaxel or 3) Temozolomide or 4) Cisplatin, or 5) Erlotinib in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Recommended Phase 2 dose [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic, concentration maximum (Cmax) [ Time Frame: Cycle 1 and cycle 2 ] [ Designated as safety issue: No ]
  • Number of patients with a tumor response [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
  • Number of participants with a clinically significant effects [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic, area under the curve (AUC) [ Time Frame: Cycle 1 and cycle 2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: July 2008
Estimated Study Completion Date: February 2015
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine plus LY573636 Drug: Gemcitabine
1000 mg/m2 administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criterion are met.
Other Names:
  • Gemzar
  • LY18011
Drug: LY573636
Individualized dose is dependent on patients height, weight, gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion are met.
Experimental: Docetaxel plus LY573636 Drug: Docetaxel
60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criterion are met.
Other Name: Taxotere
Drug: LY573636
Individualized dose is dependent on patients height, weight, gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion are met.
Experimental: Temozolomide plus LY573636 Drug: Temozolomide
200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criterion are met.
Other Name: Temodar
Drug: LY573636
Individualized dose is dependent on patients height, weight, gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion are met.
Experimental: Cisplatin plus LY573636 Drug: Cisplatin
75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criterion are met.
Other Names:
  • Platinol-AQ
  • Platinol
Drug: LY573636
Individualized dose is dependent on patients height, weight, gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion are met.
Experimental: Erlotinib plus LY573636 Drug: Erlotinib
150 mg administered orally days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criterion are met.
Other Name: Tarceva
Drug: LY573636
Individualized dose is dependent on patients height, weight, gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion are met.

  Eligibility

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

Inclusion Criteria:

  • Patients who have histologically confirmed solid malignancy or lymphoma that is unresectable and/or metastatic for which monotherapy with gemcitabine HCl, docetaxel, temozolomide, cisplatin, or erlotinib would otherwise be appropriate
  • Must have tumor progression after receiving standard/approved chemotherapy or limited treatment options
  • Must have measurable or nonmeasurable disease
  • Have given written informed consent prior to any study-specific procedures
  • Must have adequate hepatic, hematologic and renal function
  • Must 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. Endocrine therapies for the treatment of prostate cancer may be continued, at the discretion of the investigator. Whole brain radiation must have been completed 90 days before starting study therapy. Patients without evidence of brain metastases who have received prophylactic whole brain irradiation as part of standard of care for small cell lung cancer may be included in the study with a shorter washout period pending approval by the Lilly physician.
  • Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drug.
  • Females with child-bearing potential must have had a negative serum pregnancy test within 7 days prior to the first dose of study drug.
  • Must have a serum albumin level greater than or equal to 3.0 g/dL (30 g/L).
  • Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale

Exclusion Criteria:

  • Have received treatment within 30 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication
  • Have serious preexisting medical conditions that in the opinion of the investigator would preclude participation in the study
  • Patients with active central nervous system or 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 to rule out brain metastasis. Patients with stable CNS metastasis not requiring steroids may be eligible.
  • Have a current hematologic malignancy (other than lymphoma)
  • Patients with serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study)
  • Patients actively receiving warfarin (Coumadin®) therapy
  • Patients who have previously completed or withdrawn from any study investigating LY573636
  • Patients with a known hypersensitivity to one of the combination drugs cannot be enrolled to the treatment arm which includes that chemotherapeutic combination
  • Females who are pregnant or breast feeding
  • Have known positive test results of HIV, hepatitis B, or hepatitis C
  • Patients receiving amiodarone, quinidine, propofol, or clozapine.
  • Patients receiving treatment with strong or moderate inhibitors of CYP2C19, including proton-pump inhibitors (PPIs). Esomeprazole or pantoprazole are allowed if not administered 72 hours before or after LY573636 administration.
  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: NCT01284335

Locations
United States, Alabama
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.
Birmingham, Alabama, United States, 35233
United States, Arkansas
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.
Fayetteville, Arkansas, United States, 72703
United States, Colorado
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.
Denver, Colorado, United States, 80218
United States, Florida
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.
Orlando, Florida, United States, 32806
United States, Illinois
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.
Park Ridge, Illinois, United States, 60068
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, Nevada
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Las Vegas, Nevada, United States, 89169
United States, New York
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Albany, New York, United States, 12206
United States, Ohio
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.
Kettering, Ohio, United States, 45429
United States, Oregon
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.
Portland, Oregon, United States, 97213
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.
Austin, Texas, United States, 78731
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.
Dallas, Texas, United States, 75246
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
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.
Tyler, Texas, United States, 75702
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
United States, Washington
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.
Spokane, Washington, United States, 99218
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.
Vancouver, Washington, United States, 98684
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.
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 or Mon - Fri 9 AM - 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: NCT01284335     History of Changes
Other Study ID Numbers: 12267, H8K-MC-JZAK
Study First Received: January 19, 2011
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Advanced solid tumors
Unresectable
Metastatic
Limited treatment options
Measurable or nonmeasurable disease

Additional relevant MeSH terms:
Neoplasms
Cisplatin
Docetaxel
Erlotinib
Gemcitabine
Temozolomide
Alkylating Agents
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014