- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00607607
A Phase 2 Study of Oral MKC-1 in Patients With Ovarian or Endometrial Cancer
19. januar 2012 opdateret af: CASI Pharmaceuticals, Inc.
A Phase 2 Study of Oral MKC-1 Administered Twice Daily for 14 Consecutive Days Every 4 Weeks in Patients With Recurrent or Resistant Epithelial Ovarian Cancer or Advanced Endometrial Cancer
Patients will be treated with MKC-1, twice daily for 14 consecutive days every four weeks (a cycle of MKC-1 chemotherapy), until disease progression or unacceptable toxicities.
Patients will be stratified to Arm A (ovarian cancer) or Arm B (endometrial cancer), and will receive identical treatment regimens.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
44
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ontario
-
Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre
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Kingston, Ontario, Canada, K7L 5P9
- Cancer Centre of Southeastern Ontario At Kingston General Hospital
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London, Ontario, Canada, N6A 4L6
- London Health Sciences Centre
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Mississauga, Ontario, Canada, L5M 2N1
- Credit Valley Hospital
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
-
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Quebec
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Montreal, Quebec, Canada, H2L 4M1
- Hopital Notre-Dame du CHUM
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Provide written informed consent (and HIPAA authorization for release of protected health information, as applicable) prior to any study related assessments.
- Histologically confirmed epithelial ovarian cancer, primary peritoneal carcinomatosis, fallopian tube cancers, or endometrial cancer.
- Age > 18 years at the time of consent.
Arm A: Ovarian Cancer Patients:
- Must have failed at least one prior platinum based and one taxane based chemotherapeutic regimen. [Platinum failure is defined as platinum-refractory (progression while receiving a platinum-containing regimen) or platinum-resistant (disease progression within 6 months from completion of platinum containing regimen)].
- Have measurable disease according to RECIST or CA 125 criteria according to GCIG (CA-125 value of > 2 xULN).
- Have no more than 3 prior regimens for their disease.
Arm B: Endometrial Cancer Patients:
- Have no more than 3 prior regimens for their disease
- Have measurable disease according to RECIST.
- ECOG performance status of 0, 1, or 2.
The following laboratory results, within 10 days of MKC-1 administration:
- Hemoglobin greater than or equal to 90 g/L (9 g/dL)
- Absolute neutrophil count greater than or equal to 1.5 x 109/L
- Platelet count greater than or equal to 100 x 109/L
- Serum creatinine less than or equal to 1.5 x ULN (upper limit of normal)
- AST less than or equal to 2.5 x ULN
- Serum Albumin greater than or equal to 30 g/L (3.0 g/dL)
- Total bilirubin less than or equal to ULN
Exclusion Criteria:
Administration of cancer specific therapy within the following periods prior to study drug initiation:
- chemotherapy less than 3 weeks prior;
- hormonal therapy less than one week prior;
- radiation therapy less than 2 weeks prior.
- Requirement for paracentesis > 2 liters/week.
- Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile, or they must agree to use a physical method of contraception. Female patient with childbearing potential must have a negative pregnancy test within 10 days before the first MKC-1 administration.
- Known CNS metastases unless treated, clinically stable, and not requiring steroids.
- Clinical evidence of significant bowel obstruction, active uncontrolled malabsorption syndromes, or a history of total gastrectomy.
- Uncontrolled hypercalcemia (serum calcium-corrected > 3 mmol/L [12 mg/dL]).
- Serious cardiac condition (Class III/IV congestive heart failure according to New York Heart Association classification); documented acute myocardial infarction within the previous 6 months.
- Any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient. These include: infection requiring parenteral or oral anti-infective treatment, any altered mental status, or any psychiatric condition that would interfere with the understanding of the informed consent.
- Patients with previous malignancies unless free of recurrence for at least 5 years except cured basal cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix.
- Treatment with antiretroviral therapy metabolized through CYP3A4 (including indinavir, nelfinavir, ritonavir and saquinavir).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: A
Ovarian Cancer Patients
|
capsules, provided 125 mg/m2 BID x 14 days in 28 day cycles
|
Eksperimentel: B
Endometrial Cancer Patients
|
capsules, provided 125 mg/m2 BID x 14 days in 28 day cycles
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Tumor response rate (based on tumor measurements according to the RECIST criteria) or CA-125
Tidsramme: Every 4 to 8 weeks
|
Every 4 to 8 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Tid til progression
Tidsramme: Tidspunkt for progression
|
Tidspunkt for progression
|
Adverse events spontaneously declared by the patients or noted during physical examination and laboratory tests.
Tidsramme: As reported
|
As reported
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Amit Oza, MD, Princess Margaret Hospital, Canada
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2008
Primær færdiggørelse (Faktiske)
1. juni 2011
Studieafslutning (Faktiske)
1. januar 2012
Datoer for studieregistrering
Først indsendt
23. januar 2008
Først indsendt, der opfyldte QC-kriterier
23. januar 2008
Først opslået (Skøn)
6. februar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. januar 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. januar 2012
Sidst verificeret
1. januar 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Uterine neoplasmer
- Genitale neoplasmer, kvindelige
- Livmodersygdomme
- Sygdomme i det endokrine system
- Ovariesygdomme
- Adnexale sygdomme
- Gonadale lidelser
- Neoplasmer i endokrine kirtler
- Ovariale neoplasmer
- Endometriale neoplasmer
- Karcinom, ovarieepitel
Andre undersøgelses-id-numre
- MKC-103
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med MKC-1
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Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)AfsluttetUspecificeret fast tumor hos voksne, protokolspecifikForenede Stater
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)AfsluttetUspecificeret fast tumor hos voksne, protokolspecifikForenede Stater
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CASI Pharmaceuticals, Inc.AfsluttetBrystkræftForenede Stater
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CASI Pharmaceuticals, Inc.AfsluttetKræft i bugspytkirtlenForenede Stater
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Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)AfsluttetKolorektal cancerForenede Stater
-
CASI Pharmaceuticals, Inc.AfsluttetIkke-småcellet lungekræft | Avanceret kræftForenede Stater
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Statens Serum InstitutAfsluttetAktiv immuniseringPolen
-
The University of Texas Health Science Center,...National Heart, Lung, and Blood Institute (NHLBI); United States Department... og andre samarbejdspartnereAfsluttetTraumaForenede Stater, Canada
-
Orasis Pharmaceuticals Ltd.Afsluttet