A Phase 1 Study in Patients With Solid Tumors

NCT ID: NCT01215916

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2011-12-31

Brief Summary

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.

Conditions

Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Pemetrexed followed by LY573636

Pemetrexed on Day 1 followed by LY573636 on Day 4

Group Type: EXPERIMENTAL

LY573636

Intervention Type: DRUG

Individualized dose is dependent on a patient's height, weight, and gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days).

Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.

Patients are pretreated with folic acid [350 micrograms (µg) to 1000 µg orally, daily], Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone [4 milligrams (mg) orally, twice daily or equivalent].

Pemetrexed

Intervention Type: DRUG

375 to 500 milligrams per square meter (mg/m^2), intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days).

Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.

Patients are pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).

Experimental: LY573636 followed by Pemetrexed

LY573636 on Day 1, pemetrexed on Day 4

Group Type: EXPERIMENTAL

LY573636

Intervention Type: DRUG

Individualized dose is dependent on a patient's height, weight, and gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days).

Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.

Patients are pretreated with folic acid [350 micrograms (µg) to 1000 µg orally, daily], Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone [4 milligrams (mg) orally, twice daily or equivalent].

Pemetrexed

Intervention Type: DRUG

375 to 500 milligrams per square meter (mg/m^2), intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days).

Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.

Patients are pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).

Experimental: LY573636 and Pemetrexed on Day 1

LY573636 and Pemetrexed on Day 1

Group Type: EXPERIMENTAL

LY573636

Intervention Type: DRUG

Individualized dose is dependent on a patient's height, weight, and gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days).

Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.

Patients are pretreated with folic acid [350 micrograms (µg) to 1000 µg orally, daily], Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone [4 milligrams (mg) orally, twice daily or equivalent].

Pemetrexed

Intervention Type: DRUG

375 to 500 milligrams per square meter (mg/m^2), intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days).

Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.

Patients are pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).

Interventions

LY573636

Individualized dose is dependent on a patient's height, weight, and gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days).

Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.

Patients are pretreated with folic acid [350 micrograms (µg) to 1000 µg orally, daily], Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone [4 milligrams (mg) orally, twice daily or equivalent].

Intervention Type: DRUG

Pemetrexed

375 to 500 milligrams per square meter (mg/m^2), intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days).

Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.

Patients are pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).

Intervention Type: DRUG

Other Intervention Names

Tasisulam; LY231514; Alimta

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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.

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

H8K-MC-JZAE

Identifier Type: OTHER

Identifier Source: secondary_id

11158

Identifier Type: -

Identifier Source: org_study_id