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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors

Thank you

Trial Information

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


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 (CoumadinĀ®) 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended Phase 2 dose

Outcome Time Frame:

Baseline to study completion

Safety Issue:

Yes

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

12267

NCT ID:

NCT01284335

Start Date:

July 2008

Completion Date:

June 2013

Related Keywords:

  • Advanced Solid Tumors
  • Advanced solid tumors
  • Unresectable
  • Metastatic
  • Limited treatment options
  • Measurable or nonmeasurable disease
  • Neoplasms

Name

Location

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  
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. Manhassaet, New York  
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  35294
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. Jacksonville, Florida  32256
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. Chicago, Illinois  60674
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  46227
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. Las Vegas, Nevada  89169
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. Cincinnati, Ohio  45267
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. Eugene, Oregon  97401
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  29605
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. Bedford, Texas  76022
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  23502
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. Seattle, Washington  98133
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. Little Rock, Arkansas  72205