A Safety Study in Participants With Advanced Solid Tumors



Status:Terminated
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:July 2008
End Date:May 2016

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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

The purpose of this study is to determine a safe dose of LY573636 (tasisulam) when used in 5
separate combinations with an approved cancer medication for treating participants 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 combination treatments.


Inclusion Criteria:

- Participants 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. Participants
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

- Participants with active central nervous system or 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 to rule out brain
metastasis. Participants with stable CNS metastasis not requiring steroids may be
eligible.

- Have a current hematologic malignancy (other than lymphoma)

- Participants with serious concomitant disorders, including active bacterial, fungal,
or viral infection, incompatible with the study)

- Participants actively receiving warfarin (Coumadin®) therapy

- Participants who have previously completed or withdrawn from any study investigating
LY573636

- Participants 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

- Participants receiving amiodarone, quinidine, propofol, or clozapine.

- Participants 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.
We found this trial at
19
sites
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Fayetteville, AR
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Denver, CO
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Greenville, South Carolina 29605
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Greenville, SC
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Indianapolis, IN
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Kettering, OH
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Las Vegas, NV
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Norfolk, VA
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Orlando, FL
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Park Ridge, IL
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Portland, OR
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Spokane, WA
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The Woodlands, TX
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Tyler, TX
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Vancouver, WA
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Yakima, WA
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