- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00558922
A Phase 1-2 XIAP Antisense AEG35156 With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer
29. juli 2009 oppdatert av: Aegera Therapeutics
A Phase 1-2, Multicenter, Open-Label Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer
This is an open-label multicenter, phase 1-2 study.
Following determination of the recommended AEG35156 dose in combination with carboplatin and paclitaxel in the initial Phase 1 part of this study, additional patients will be enrolled in the Phase 2 part of the study to assess the activity of the combination in advanced non small cell lung cancer.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Apoptotic induction in cancer cells is a sought after therapeutic goal.
Most successful anticancer agents activate apoptosis pathways in the cancers they treat.
Apoptotic pathways in cells appear to converge on a single family of enzymes, the caspases, which are proteases that dismantle the cell in an orderly, non-inflammatory fashion, resulting in cell death.
The X-linked Inhibitor of Apoptosis (XIAP) is the only known cellular inhibitor of caspases, its over expression thereby blocking the principal means of apoptosis.
A wide range of evidence indicates that cellular overexpression of members of the IAP family is a fundamental means by which many cancer cells evade death, even in the presence of strong extrinsic (death receptor-mediated) and intrinsic (mitochondria-mediated) apoptotic cues.
The inhibition of cellular XIAP activity, specifically in cancer cells under stress and primed for apoptosis by chemotherapeutic agents, is viewed as a powerful means of tipping the balance towards cell death.
In particular, XIAP down regulation has been shown to enhance taxane cytotoxicity preclinically.
AEG35156 is a second generation antisense which targets XIAP mRNA to lower XIAP levels and the apoptotic threshold of cancer cells, enhancing their sensitivity to intrinsic death and chemotherapy.
AEG35156 may thus enhance the anticancer activity of carboplatin and paclitaxel in patients with advanced non small cell lung cancer
Studietype
Intervensjonell
Registrering (Faktiske)
54
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Colorado
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Denver, Colorado, Forente stater, 80218
- Rocky Mountain Cancer Center
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Indiana
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Indianapolis, Indiana, Forente stater, 46219
- Central Indiana Cancer Center
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Ohio
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Dayton, Ohio, Forente stater, 45409
- Dayton Oncology & Hematology, P.A.
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South Carolina
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Greenville, South Carolina, Forente stater, 29605
- Cancer Centers of the Carolinas
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Virginia
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Norfolk, Virginia, Forente stater, 23502
- Virginia Oncology Associates
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Washington
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Vancouver, Washington, Forente stater, 98684
- Northwest Cancer Specialists, P. C.
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients with histologically or cytologically confirmed stage IIIB (malignant pleural effusion) or stage IV non small cell lung cancer who are candidates for carboplatin and paclitaxel chemotherapy for metastatic disease
- ECOG performance < 2
- One or more tumors measurable by RECIST criteria on CT scan or MRI (Phase 2 part only)
- Life expectancy of at least 3 months
- Age > 18 years
- Signed, written IRB-approved informed consent
- A negative serum pregnancy test (if applicable)
- Acceptable liver function:
- Bilirubin within normal limit
- AST (SGOT), ALT (SGPT) and Alkaline phosphatase < 2.0 times the institution's upper limit of normal
- Acceptable renal function:
- Serum creatinine within normal limits, OR calculated creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Acceptable hematologic status:
- Granulocyte > 1500 cells/uL
- Platelet count > 100,000 plt/uL
- Hemoglobin > 9.0 g/dL
- Acceptable coagulation status:
- PT within normal limits
- PTT within normal limits
- For women of child-bearing potential, the use of effective contraceptive methods during the study
- Prior radiotherapy is allowed provided disease progression outside the radiation field has been documented, treatment completed at least 2 weeks prior to registration and less than 25% of the bone marrow exposed
Exclusion Criteria:
- Prior chemotherapy for metastatic disease.
- Patients with prior history of peripheral neuropathy
- Patients with hypersensitivity to platinum containing compounds, mannitol or drugs formulated in Chremophor EL.
- Active progressive brain metastases including the presence of any related symptoms or need for corticosteroids. A CT or MRI scan of the head is necessary in patients with a history of brain metastases to document the stability of prior lesions.
- Known bleeding diathesis
- Pregnant or nursing women. NOTE: Women of child-bearing potential must agree to use adequate contraception (sterile or surgically sterile; hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Men who are unwilling to use acceptable forms of birth control when engaging in sexual contact with women of child bearing potential
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Known infection with HIV, hepatitis B, or hepatitis C
- Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
- Patients who have received any other investigational agent within the last 30 days. Subjects who have used a previous antisense oligonucleotide in the last 90 days will be excluded
- Unwillingness or inability to comply with procedures required in this protocol
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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To determine the recommended dose of AEG35156 when used in combination with carboplatin and paclitaxel and if the dose can enhance the response rate of carboplatin and paclitaxel in patients with advanced non small cell lung cancer.
Tidsramme: 2 years
|
2 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
For å bestemme progresjonsfri overlevelse.
Tidsramme: 2 år
|
2 år
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Jacques Jolivet, MD, FACP, Aegera Therapeutics, Inc.
- Hovedetterforsker: Robert M Jotte, MD, Rocky Mountain Cancer Centers
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2007
Primær fullføring (Forventet)
1. august 2009
Studiet fullført (Forventet)
1. oktober 2009
Datoer for studieregistrering
Først innsendt
13. november 2007
Først innsendt som oppfylte QC-kriteriene
13. november 2007
Først lagt ut (Anslag)
15. november 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
30. juli 2009
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. juli 2009
Sist bekreftet
1. juli 2009
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AEG35156-203
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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