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Temsirolimus In Phase 0

20. juni 2014 opdateret af: M.D. Anderson Cancer Center

Phase 0 Trial Evaluating the Effect of Temsirolimus on Known Pharmacodynamic Targets

The goal of this clinical research trial is to study the effects of the FDA-approved drug, temsirolimus, using a new type of clinical study design called a "Phase 0." This type of study may be able to predict if a drug can affect cancer and may be able to prevent potentially useful study drugs from being discarded before they are fully tested.

The purpose of the study is not to treat the cancer, but to help improve general cancer treatment knowledge.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Study Drug:

Temsirolimus is designed to block the growth of cancer cells, which may cause the cancer cells to die.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive temsirolimus by vein over about 60 minutes on Day 1.

You will be assigned to a dose level of temsirolimus based on when you join this study. Up to 5 dose levels of temsirolimus will be tested. Up to 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, until the drug is found to affect the enzyme that was tested for at screening.

Study Visits:

At each study visit, you will be asked about any drugs you may be taking and about any side effects you may be having.

On Day 1:

-Blood (about 2 teaspoons each time) will be drawn before you receive the study drug and 5 times over the 24 hours after you receive the study drug for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points.

Blood (about 4 teaspoons each time) will be drawn for pharmacodynamic (PD) testing. PD testing measures how the level of study drug in your body may affect the disease. This blood will be drawn at 1 or more of the following times, but if the doctor thinks it is needed, blood will be drawn at 2 or all 3 of the following times:

  • At 4 hours (+/- 2 hours) after the dose
  • At 24 hours (+/- 3 hours) after the dose
  • At 72 hours (+/- 24 hours) after the dose

After the blood for PD testing has been tested and the tests show that the study drug may be causing changes to the tumor cells in at least 2 out of 3 participants, future participants will have tumor tissue collected before and after dosing for testing. Leftover tissue from an earlier biopsy can be used instead of a fresh biopsy before dosing, if it is available.

Length of Study:

You will be on study for up to 4 days. You will be taken off study early if you have intolerable side effects.

Because it takes 4 days for temsirolimus to be completely processed by the body, you will not be able to begin receiving drugs in any other study until 4 days after the dose.

This is an investigational study. Temsirolimus is FDA approved and commercially available for the treatment of advanced renal cancer. Its use in other types of cancer is investigational.

Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • UT MD Anderson Cancer Center

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

Alle

Beskrivelse

Inclusion Criteria:

  1. Patients with advanced or metastatic cancer, preferably with tumor easily accessible for biopsy.
  2. Patients should be at least four weeks or 5 half lives from the last day of chemotherapy, antibody or other biological therapy, whichever is shorter.
  3. Patients should preferably be undergoing screening for 2007-0668, 2008-0384, 2008-0425, and 2008-0827 (currently active Phase I trials involving temsirolimus). However, patients may also be allowed on protocol if they are undergoing screening for any study.

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. Patients with a known hypersensitivity to any of the components or metabolites of the drug products.
  3. Patients with a known bleeding diathesis which would prevent safely obtaining a biopsy if a biopsy is indicated.
  4. Patients who are less than 18 years of age.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Temsirolimus
Starting dose 0.02 mg intravenous administered once.
Medicin: Temsirolimus
Starting dose will be 0.02 mg intravenous administered once on Day 1 over 60 minutes.
Andre navne:
  • Torisel
  • CCI-779

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participants' Pharmacodynamic (PD) Responses
Tidsramme: Blood drawn at 4 hours (+/- 2 hours) after study drug
PD response, significant S6 Kinase 1 (S6K1) inhibition, is defined at both the patient level and the dose level, 1) as compared with baseline, at least 50% reductions of S6K1 after treatment (biological criterion); 2) differences in log transformed S6K1 activity between post-treatment and baseline should be greater than threshold of 1.8 times standard deviation (SD) of baseline, which yields a 90% statistical confidence that it is not due to chance variation (statistical criterion).
Blood drawn at 4 hours (+/- 2 hours) after study drug

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

M.D. Anderson Cancer Center

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Daniel Karp, MD, UT MD Anderson Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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. august 2010

Primær færdiggørelse (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først indsendt

12. august 2011

Først indsendt, der opfyldte QC-kriterier

12. august 2011

Først opslået (Skøn)

16. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2010-0259
  • NCI-2011-02799 (Registry Identifier: NCI CTRP)
  • 2K12CA088084-12 (U.S. NIH-bevilling/kontrakt)

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 Avanceret kræft

Kliniske forsøg med Temsirolimus

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner