Clinical trial NCT01215916: A Phase 1 Study in Patients With Solid Tumors
Official title: A Phase 1b Study of LY573636-sodium in Combination With Alimta (Pemetrexed) in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Solid tumors
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-10-07
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Recommended Phase 2 Dose
timeFrame: Baseline to toxicity [up to end of Cycle 1 (cycle = 21 or 28 days)]
Secondary outcomes:
measure: Number of Participants With Clinically Significant Effects
timeFrame: Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
measure: Percentage of Participants With a Tumor Response
timeFrame: Baseline to progressive disease (up to 1 year of treatment plus 30-day follow-up)
measure: Pharmacokinetics, Concentration Maximum (Cmax) of LY573636
timeFrame: Cycles 1 and 2 on Day 4 (prior to and at the end of LY573636 infusion, 2 and 4 hours post LY573636 infusion), Day 8 (anytime), Day 15 (anytime)
measure: Pharmacokinetics, Area Under the Curve (AUC) of LY573636
timeFrame: Cycles 1 and 2 on Day 4 (prior to and at the end of LY573636 infusion, 2 and 4 hours post LY573636 infusion), Day 8 (anytime), Day 15 (anytime)
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: 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.
state: New Jersey
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: