- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00005845
Tipifarnib in Treating Patients With Myelodysplastic Syndromes
Phase I Study of the Farnesyl Transferase Inhibitor R115777 (NSC #702818) in Patients With Myelodysplastic Syndrome
Studieoversikt
Status
Forhold
- Kronisk myelomonocytisk leukemi
- Tidligere behandlede myelodysplastiske syndromer
- de Novo myelodysplastiske syndromer
- Ildfast anemi
- Ildfast anemi med overflødig eksplosjon
- Refraktær cytopeni med multilineage dysplasi
- Ildfast anemi med overskytende eksplosjoner i transformasjon
- Refraktær anemi med ringede sideroblaster
Intervensjon / Behandling
Detaljert beskrivelse
PRIMARY OBJECTIVES:
I. To determine the toxicity profile and antitumor activity of the farnesyltransferase (FTase) inhibitor R115777 (tipifarnib) in patients with myelodysplastic syndrome (MDS) treated on a one week on/one week off schedule.
II. To determine the effect on R115777 on a one week on/one week off schedule on FTase activity, prenylation of RAS and other substrates and on downstream effects.
OUTLINE: This is a dose-escalation study.
Patients receive tipifarnib orally (PO) twice daily (BID) on weeks 1, 3, 5, and 7. Treatment repeats every 8 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- M D Anderson Cancer Center
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Patients must have histologically MDS (including French-American-British [FAB] types refractory anemia [RA], refractory anemia with ringed sideroblasts [RARS], refractory anemia with excess blasts [RAEB], refractory anemia with excess blasts in transformation [RAEBT], or chronic myelomonocytic leukemia [CMMoL]); for the purpose of the study, all patients will be classified by World Health Organization (WHO) criteria
- By these criteria, FAB RA are split into:
Pure dyserythropoietic refractory anemia (PRA)
- Refractory cytopenia with multilineage dysplasia (RCMD)
FAB RARS is split into:
- Pure sideroblastic anemia (PSA)
- Refractory sideroblastic cytopenia with multilineage dysplasia (RSCMD)
FAB RAEB is split into:
- RAEB I (< 10% BM blasts)
- RAEB II (10-20% BM blasts)
- Patients with CMMoL, and RAEBT by FAB classification will be included in the protocol
- Prognosis will be assessed by International Prognostic Scoring System (IPSS) criteria
- =< 2 prior therapies
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Life expectancy of greater than 12 weeks
- Bilirubin =< 1.5mg %
- Creatinine =< 1.5mg %
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) 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
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 4 weeks (3 months for UCN01) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to R115777 (such as imidazoles)
- Patients eligible for bone marrow transplant (=< 60 years old), with a compatible sibling, no contraindications for transplant
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with R115777.
- Growth factors other than filgrastim (G-CSF) are excluded; patients should be off excluded growth factors for 2 weeks
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Treatment (tipifarnib)
Patients receive tipifarnib PO BID on weeks 1, 3, 5, and 7. Treatment repeats every 8 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
|
Korrelative studier
Korrelative studier
Andre navn:
Gitt PO
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
MTD defined as the next lower dose level at which 2 patients experience dose limiting toxicity (DLT) defined as grade 3 or 4 toxicity according to the Cancer Therapy Evaluation Program Common Toxicity Criteria
Tidsramme: Up to 8.5 years
|
The final analysis will report all toxicities by grade, dose, cycle, and by cumulative dose.
|
Up to 8.5 years
|
Response rate
Tidsramme: Up to 8.5 years
|
Will be reported overall and by dose level.
|
Up to 8.5 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
FTase inhibition
Tidsramme: Up to 8.5 years
|
Based on the shape of the relationship (e.g.
linear vs saturation vs peak), a dose response analysis will be performed to describe/summarize the relationship (correlation analysis or curve-fitting).
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Up to 8.5 years
|
Accumulation of unfarnesylated lamin B1
Tidsramme: Up to 8.5 years
|
Based on the shape of the relationship (e.g.
linear vs saturation vs peak), a dose response analysis will be performed to describe/summarize the relationship (correlation analysis or curve-fitting).
|
Up to 8.5 years
|
Accumulation of RAS proteins
Tidsramme: Up to 8.5 years
|
Based on the shape of the relationship (e.g.
linear vs saturation vs peak), a dose response analysis will be performed to describe/summarize the relationship (correlation analysis or curve-fitting).
|
Up to 8.5 years
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Razelle Kurzrock, M.D. Anderson Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Neoplasmer etter histologisk type
- Neoplasmer
- Sykdom
- Benmargssykdommer
- Hematologiske sykdommer
- Forstadier til kreft
- Myelodysplastiske-myeloproliferative sykdommer
- Leukemi
- Leukemi, myeloid
- Syndrom
- Myelodysplastiske syndromer
- Preleukemi
- Leukemi, myelomonocytisk, kronisk
- Leukemi, myelomonocytisk, juvenil
- Anemi
- Anemi, ildfast, med overskudd av eksplosjoner
- Anemi, ildfast
- Antineoplastiske midler
- Tipifarnib
Andre studie-ID-numre
- NCI-2009-01158 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- U01CA062461 (U.S. NIH-stipend/kontrakt)
- 5625 (Annen identifikator: CTEP)
- CDR0000067862
- DM01-582 (Annen identifikator: M D Anderson Cancer Center)
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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