- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01555242
A Study of Aneustat (OMN54) in Patients With Advanced Cancer and Lymphomas
7. april 2015 opdateret af: Omnitura Therapeutics, Inc.
A Phase I, Open-Label, Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Aneustat™ (OMN54) Administered on a Daily Oral Regimen in Patients With Advanced Cancer and Lymphomas
This is a phase I, open-label, multiple dose, dose escalation study to assess the safety, tolerability and pharmacokinetics of Aneustat™ (OMN54), a novel therapy, administered orally in patients with advanced cancer and lymphomas.
Studieoversigt
Detaljeret beskrivelse
Patients who complete a 28-day cycle, may be eligible to continue receiving Aneustat™ (OMN54) in 4-week increments for up to 6 cycles (inclusive of cycle 1) if further treatment is judged to be of possible benefit; if patient has not experienced unacceptable toxicity; and no study withdrawal criteria has been met.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
22
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- BC Cancer Agency-Vancouver Centre
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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:
- Histological or cytological evidence of malignancy
- Male or female, 18 years or older
- Presence of advanced tumours, i.e., measurable or non-measurable disease (RECIST criteria, version 1.1)that have recurred or progressed following standard therapy
- Able to swallow the oral capsule form of the drug
- Failed at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
Haematology within 7 days of Day 1 (initial dose):
- Hemoglobin (Hb) > 9.0 g/dL
- Platelets ≥ 100,000 cells/mm3 (or, ≥100 x 10/L)
- Absolute neutrophil count (ANC) > 1.5 cells x109/L (or, > 1500 cells/mm3)
Chemistry within 7 days of Day 1 (initial dose):
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x ULN if no liver metastases, AST(SGOT)/ALT(SGPT) < 5 x ULN if liver metastases
- Bilirubin < 1.5 x ULN unless Gilbert's Syndrome
- Serum creatinine ≤ 1.25 ULN
Coagulation within 7 days of Day 1 (initial dose):
*INR ≤ 1.5
- ECOG Performance Status between 0 - 2 and estimated life expectancy of > 3 months.
- Having the initiative and means to be compliant with the protocol (as judged by the Principal Investigator) and is within a feasible geographical proximity of the study center to make the required study visits.
- Written informed consent obtained prior to any study screening procedures
- Females of childbearing potential (a female is considered of childbearing potential unless she is postmenopausal, i.e., no menses for at least 12 consecutive months, or is without a uterus) must have a negative urine pregnancy test (UPT) within 7 days of Day 1 (initial dose)
- Females of childbearing potential must agree to use an effective method of contraception (i.e., sexual abstinence, condoms, intrauterine device, diaphragm) from Screening period and throughout study participation.
Exclusion Criteria:
- Patient has uncontrolled or symptomatic brain metastases (If a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days prior to Day 1 dosing).
- Use of an investigational medication or device within 30 days of initiating study therapy (Day 1).
- Major surgery within 30 days prior to first dose (Day 1).
- Radiotherapy, chemotherapy, or immunotherapy within 28 days prior to Day 1 (not including palliative radiotherapy at focal sites).
- Pregnancy or lactation.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NY Heart Association Class III or IV, see Appendix 3), unstable angina pectoris, unstable cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements.
- Screening (within approximately 28 days of registration) 12-lead electrocardiogram (ECG) that is abnormal and clinically significant
- Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption.
- Use of warfarin, i.e., Coumadin®, Jantoven® within 7 days prior to Day 1 (initial dosing)
- Intolerance or aversion to porcine ingredients that are used for the OMN54 oral capsules in the investigational medicine, OMN54 (Aneustat™).
- Known hypersensitivity to any of the three botanical constituents of Aneustat™ (OMN54), or other similar plants; or to plants belonging to Labiatae or Lamiaceae families, soy, or Aneustat™ (OMN54) excipients
- Use of Sophora subprostrata root (SSR) or herba serissae within 14 days prior to Day 1.
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 |
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Eksperimentel: Aneustat (OMN54)
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100 mg active/capsule; oral administration; 28 days/cycle (up to 6 cycles total) 1,000 mg QD 2,000 mg QD 1,500 mg BID 2,000 mg BID 2,500 mg BID
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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Maximum Tolerated Dose (MTD) of two dosing regimens (once daily and twice daily)
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The maximum tolerated dose (MTD) is defined as the dose, based on data from 6 patients (or 5 patients if one patient has withdrawn due to non-Aneustat (OMN54) related reasons), below the non-tolerated dose (DL T).
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Dose Limiting Toxicity (DLT) of two dosing regimens (once daily and twice daily)
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Assessment per Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
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Plasma blood concentrations of chemical markers
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These measurements are intended to characterize the pharmacokinetics of Aneustat (OMN54)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
---|---|
Tumor Response
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Tumor response as per RECIST criteria version 1.1, and tumor markers in plasma, as applicable
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Measurement of pathway biomarkers in plasma
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Plasma concentrations of cancer-related proteins to help characterize Aneustat (OMN54) activity
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 2012
Primær færdiggørelse (Faktiske)
1. januar 2014
Studieafslutning (Faktiske)
1. januar 2014
Datoer for studieregistrering
Først indsendt
13. marts 2012
Først indsendt, der opfyldte QC-kriterier
14. marts 2012
Først opslået (Skøn)
15. marts 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. april 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. april 2015
Sidst verificeret
1. april 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OMN54-101
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 .
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