- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00088023
Safety Study of PT-523 in Cancer Patients to Treat Solid Tumors Including a Preliminary Assessment of Effectiveness
A Phase I Study of PT-523 in Patients With Solid Tumors
Studieoversigt
Detaljeret beskrivelse
The primary objectives of this study are 1) to evaluate the safety of a short intravenous infusion of PT-523 when administered on days 1, 8, and 15 of a 28-day cycle to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist; and 2) to establish the maximum tolerated dose (MTD) and identify the dose limiting toxicities (DLT) of PT-523.
The secondary objectives of this study are to determine the pharmacokinetics and to evaluate preliminary efficacy of PT-523.
Undersøgelsestype
Tilmelding
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
-
Boston, Massachusetts, Forenede Stater, 02215
- Beth Isreal Deaconess Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Presence of metastatic or inoperable malignancy, other than leukemia or a primary central nervous system (CNS) tumor, for which there is no known curative or survival prolonging palliative therapy, or failure of these therapies .
- Age greater than or equal to 18 years.
- Life expectancy greater than or equal to 2 months.
- ECOG performance status 0 - 2.
- Adequate organ function and bone marrow reserve.
- Use of appropriate contraceptive method.
- Sign patient informed consent.
Exclusion Criteria:
- Active brain metastases.
- Presence of third-space fluid collections (pleural effusion, ascites).
- Major surgery within 3 weeks prior to dosing.
- Prior chemotherapy or radiation therapy within 3 weeks prior to dosing (6 weeks for nitrosoureas or mitomycin-C). Prior antifolate therapy is permitted, as long as it has not been administered within 3 weeks prior to dosing with PT-523.
- Prior bone marrow transplantation.
- Presence of uncontrolled serious medical or psychiatric illness.
- Patients requiring radiation therapy.
There are no limitations on the extent or type of prior therapy received by the patient other than the time intervals indicated above, as long as the patient has demonstrated complete recovery from any adverse effects, and fulfills all relevant inclusion criteria.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Joseph Paul Eder, M.D., Dana-Farber Cancer Institute
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 02-000
- DFCI Legacy- 03-183
- CTEP Grant No.- UO1-CA62490-09
- NSC No.- 712783
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 Neoplasmer
-
Guangzhou First People's HospitalAfsluttet
Kliniske forsøg med PT-523 til injektion
-
Spectrum Pharmaceuticals, IncTrukket tilbageIkke-småcellet lungekarcinomForenede Stater, Den Russiske Føderation
-
Spectrum Pharmaceuticals, IncTrukket tilbageLeukæmiForenede Stater
-
HutchmedAktiv, ikke rekrutterendeImumun Trombocytopeni (ITP) Human Mass BalanceKina
-
Hutchison Medipharma LimitedIqvia Pty LtdUkendtHæmatologiske maligniteterAustralien
-
Hutchison Medipharma LimitedAfsluttetReumatoid arthritis (RA)Australien
-
HutchmedAktiv, ikke rekrutterendeNon Hodgkin lymfomSpanien, Forenede Stater, Danmark, Frankrig, Finland, Italien, Polen
-
Wyeth is now a wholly owned subsidiary of PfizerAfsluttet
-
Hutchison Medipharma LimitedUkendt
-
Wyeth is now a wholly owned subsidiary of PfizerAfsluttet
-
BioMed Valley Discoveries, IncAfsluttet