A Phase 1 Study in Patients With Solid Tumors

Lilly

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: LY573636; Drug: Pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT01215916

H8K-MC-JZAE (Other Identifier)

11158 (Registry Identifier)

Details and patient eligibility

About

The primary objective of this study is to determine the maximum tolerated dose (MTD) regimen for the combination therapy of LY573636 and pemetrexed that may be safely administered to patients with a solid tumor that is not amenable to curative therapy.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 grams per deciliter (g/dL) [30 grams per liter (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 satisfactory
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

Experimental: Pemetrexed followed by LY573636

Experimental group

Description:

Pemetrexed on Day 1 followed by LY573636 on Day 4

Treatment:

Drug: LY573636

Drug: Pemetrexed

Experimental: LY573636 followed by Pemetrexed

Experimental group

Description:

LY573636 on Day 1, pemetrexed on Day 4

Treatment:

Drug: LY573636

Drug: Pemetrexed

Experimental: LY573636 and Pemetrexed on Day 1

Experimental group

Description:

LY573636 and Pemetrexed on Day 1

Treatment:

Drug: LY573636

Drug: Pemetrexed