Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer

Completed · Phase 2

Conditions studied: Adenocarcinoma, Non-Small-Cell Lung Carcinoma, Lung Neoplasms

In brief

The purpose of this study is to determine the effect of MGd in non-small-cell lung cancer (NSCLC) when given alone, and to evaluate the difference between two dosing regimens.

Key facts

Study ID

NCT00129844

Run by

Pharmacyclics LLC.

People needed

108

Starts

2005-09-01

Expected to finish

2007-12-01

Last updated by the study team

2008-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >18 years old
• Histologically or cytologically confirmed diagnosis of NSCLC
• Unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC patients who have received one prior platinum-based chemotherapy regimen
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• ECOG performance status score of 0 or 1
• Willing and able to provide written informed consent

You may not qualify if…

• Laboratory values of:
• Absolute neutrophil count < 1500/ul;
• Platelet count < 75,000/ul;
• Hemoglobin < 10 gm/dl;
• AST or ALT > 3 x the upper limit of normal (ULN);
• Alkaline phosphatase > 5 x ULN;
• Bilirubin > 2 x ULN;
• Serum creatinine > 2.0 mg/dL.
• Symptomatic or uncontrolled (untreated or treated and progressing) brain metastasis.
• Evidence of meningeal metastasis.
• Greater than one prior cytotoxic regimen (not counting adjuvant or neoadjuvant cytotoxic chemotherapy if completed > 12 months prior to cytotoxic regimen).
• Chemotherapy, radiation therapy, experimental therapy, immunotherapy or systemic biologic anticancer therapy within 21 days before beginning study treatment.
• Significant weight loss > 10% of body weight in preceding 6 weeks.
• Treatment for another cancer within 3 years of enrollment, unless basal cell carcinoma or cervical cancer in situ.
• Myocardial infarction within 6 months of enrollment or congestive heart failure rated New York Heart Association (NYHA) Class III or IV.
• Uncontrolled hypertension (systolic blood pressure > 160 mm Hg and diastolic blood pressure > 110 mm Hg on maximal medical therapy).
• Known history of porphyria (testing not required at screening visit).
• Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening visit).
• Known history of HIV infection (testing not required at screening visit).
• Female who is pregnant or lactating (serum pregnancy test is required for all female patients of childbearing potential).
• Sexually active male or female of childbearing potential unwilling to use adequate contraceptive protection.
• Physical or mental condition that makes patient unable to complete specified follow-up assessments.

Where it is running

• Study site — Fountain Valley, California, United States
• Study site — Los Angeles, California, United States
• Study site — Palm Springs, California, United States
• Study site — Columbia, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Rochester, New York, United States
• Study site — Akron, Ohio, United States
• Study site — Knoxville, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Calgary, Alberta, Canada
• Study site — Edmonton, Alberta, Canada
• Study site — Kingston, Ontario, Canada
• Study site — Ottawa, Ontario, Canada
• Study site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.