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A Phase 1b Study of LY573636-sodium in Combination With Alimta (Pemetrexed) in Patients With Solid Tumors

Phase 1
18 Years
Not Enrolling
Solid Tumors

Thank you

Trial Information

A Phase 1b Study of LY573636-sodium in Combination With Alimta (Pemetrexed) in Patients With Solid Tumors

Inclusion Criteria:

- You must have a diagnosis of a solid tumor malignancy that is not amenable to
curative therapy

- You must have a serum albumin level greater than or equal to 3.0 g/dL (30 g/L)

- You must have a performance status of 0 or 1 on the Eastern Cooperative Oncology
Group (ECOG) scale

- You must be reliable and willing to make yourself available for the duration of the
study and are willing to follow study procedures

- Patients with reproductive potential should use medically approved contraceptive
precautions during the trial and for 6 months following the last dose of study drugs

- Your test results assessing the function of your blood, kidneys, liver, and heart are

- You must be willing to take folic acid, vitamin B12 or prophylactic steroids

- You must able to interrupt the use of aspirin (other than an aspirin dose less than
or equal to 1.3 grams per day) and/or other nonsteroidal anti-inflammatory agents for
2 days before, the day of, and 2 days after the dose of pemetrexed (5 days prior for
long-acting agents, such as piroxicam).

- You must have discontinued all previous therapies for cancer, including chemotherapy,
radiotherapy, immunotherapy, hormone therapy, or other investigational therapy for at
least 4 weeks (6 weeks for mitomycin-C or nitrosoureas) before 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.

- You must sign an informed consent

Exclusion Criteria:

- You cannot have received other investigational drugs within the last 30 days

- You cannot have other on-going serious illnesses including active bacterial, fugal,
or viral infections

- You cannot require regular, periodic paracentesis or thoracentesis

- You cannot have active brain metastasis

- You cannot currently be receiving warfarin (Coumadin®) therapy

- You cannot be pregnant or lactating

- You cannot have received prior Pemetrexed or LY573636

- You cannot have a second primary malignancy that could affect interpretation of the
study results

Type of Study:


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:


Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon.-Fri. 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

December 2011

Related Keywords:

  • Solid Tumors
  • Solid tumors
  • Neoplasms



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.Cherry Hill, New Jersey  08003