- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00129844
Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer
Randomized Phase II Trial of Single Agent Motexafin Gadolinium for Second Line Treatment of Non-Small-Cell Lung Cancer
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Outline:
Two-arm, open-label, randomized, 2-stage Phase II trial. Patients will be randomized on the first stage to 1 of 2 treatment arms:
Arm A - 10 mg/kg MGd once per week
Arm B - 15 mg/kg MGd once every 3 weeks
Patients will be treated on 3 week cycles, up to a maximum of 8 cycles (24 weeks). Patients with either objective response or stable disease after 2 cycles will receive up to 8 cycles of therapy. Patients with progressive disease will be terminated from the study.
At the end of Stage I, both treatment arms will be evaluated, and only the arm(s) that demonstrate at least one response (Complete Response or Partial Response) will proceed to Stage II. If both arms demonstrate a response, then both will proceed to Stage II.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
Kontakter och platser
Studieorter
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California
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Fountain Valley, California, Förenta staterna
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Los Angeles, California, Förenta staterna
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Palm Springs, California, Förenta staterna
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Missouri
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Columbia, Missouri, Förenta staterna
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St. Louis, Missouri, Förenta staterna
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Nebraska
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Omaha, Nebraska, Förenta staterna
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New Mexico
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Albuquerque, New Mexico, Förenta staterna
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New York
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Rochester, New York, Förenta staterna
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Ohio
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Akron, Ohio, Förenta staterna
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Tennessee
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Knoxville, Tennessee, Förenta staterna
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Nashville, Tennessee, Förenta staterna
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Alberta
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Calgary, Alberta, Kanada
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Edmonton, Alberta, Kanada
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Ontario
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Kingston, Ontario, Kanada
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Ottawa, Ontario, Kanada
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Quebec
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Montreal, Quebec, Kanada
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- >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
Exclusion Criteria:
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
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To estimate the response rates of two different MGd dosing regimens for the treatment of NSCLC
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Sekundära resultatmått
Resultatmått |
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To select the most effective regimen based on tumor response
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To estimate the time to progression
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To estimate survival
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To evaluate the safety and tolerability of 2 dosing regimens of MGd in NSCLC patients
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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Robert Natale, M.D., Aptium Oncology, Inc. Cedars-Sinai Outpatient Cancer Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PCYC-0227
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