- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03545711
Safety and Efficacy of Anlotinib in Combination With Irinotecan in Patients With Pretreated Advanced Colorectal Cancer
3. august 2018 oppdatert av: Jing Huang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Safety and Efficacy of Irinotecan Combined With Anlotinib in Patients With Pretreated Advanced Colorectal Cancer
Patients with pretreated advanced colorectal cancer are recruited to the phase I portion of this prospective non-randomised study in an escalated dose cohort.
The primary endpoint of the dose-escalation phase is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of anlotinib when given in combination with irinotecan.
The phase II (dose-expansion) portion is designed to characterize the safety and potential efficacy of the combination therapy in pretreated advanced colorectal cancer patients.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
42
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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-
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Beijing, Kina, 100021
- Rekruttering
- Jing Huang
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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 til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- willing and able to provide written informed consent and comply with the requirements of the study
- histologically- or cytologically-confirmed advanced colorectal cancer
- failed or intolerable to at least one prior therapy
- have evidence of measurable disease per RECIST v1.1
- Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1
- weight ≥40kg
- life expectancy >12 weeks
Exclusion Criteria:
Subjects meeting any of the following criteria are ineligible for participation in the study:
- history of any anti-cancer therapy (including investigational agents) within 28 days prior to study entry
- presence of toxicity of prior anti-cancer therapy that has not resolved to Grade 1, as determined by National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
- symptomatic brain metastasis requiring active treatment
- any previous malignancy, except for non squamous-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix within 5 years prior to study entry
- active or clinically unstable infection requiring systemic therapy
- unable to swallow oral medications or with gastrointestinal disorders that might interfere with proper absorption of oral drugs
- active digestive ulcer disease, inflammatory bowel disease, intestinal obstruction or any other condition that, in the clinical judgment of the Principal Investigator, may cause severe gastrointestinal bleeding or perforation
- unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic event ≤2 months prior to study entry
- history of stroke or transient ischemic attack (TIA) within 12 months prior to study entry
any of the following abnormal findings in organ or marrow function 1 week prior to study entry:
- Leukocytes < 1.5*10^9/L, or Platelets < 100*10^9/L, or Hb< 90g/L
- Total bilirubin > 1.5 × institutional upper limit of normal (ULN), or AST (aspartate amino transferase)/ALT (alanine amino transferase)> 3 × institutional ULN for liver metastases, > 1.5 × institutional ULN in case of no liver metastases
- any electrolyte imbalance of clinical significance
- creatinine > institutional ULN and creatinine clearance < 60 mL/min
- spot urine protein ≥(2+) or 24-hour proteinuria ≥1.0g/24h
- APTT (activated partial thromboplastin time) or INR (international normalized ratio for prothrombin time) > 1.5 × institutional ULN
- treatment refractory hypertension defined as a blood pressure of systolic> 140 millimeter of mercury (mm Hg) and/or diastolic > 90 mm Hg which cannot be controlled by a single anti-hypertensive agent
- LVEF (left ventricular ejection fraction ) <50%
- history of acute coronary syndromes (including myocardial infarction and unstable angina), coronary artery bypass graft within 6 months prior to study entry, or history or evidence of current ≥ Class II congestive heart failure as defined by New York Heart Association (NYHA)
- present with non-healing fractures of bone or wounds of skin
- pregnant or lactating female
- sexually active female (of childbearing potential) or male unwilling to adopt an effective method of birth control during the course of the study
- serious and/or unstable pre-existing psychiatric disorder
- familial, sociological or geographical conditions that, in the clinical judgment of the Principal Investigator, do not permit compliance with the protocol
- known immediate or delayed hypersensitivity reaction to anlotinib, irinotecan or their excipients
- administration of irinotecan in prior treatments
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)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Anlotinib plus Irinotecan
|
Dose escalation of anlotinib starts from 8mg qd d1-14/q21d in combination with fixed dose of irinotecan at 180mg/m2 d1/q14d.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
MTD
Tidsramme: 6 months
|
the maximum tolerated dose (MTD) of Anlotinib when administered in combination with fixed dose of irinotecan in advanced colorectal cancer patients.
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6 months
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ORR
Tidsramme: 18 months
|
the overall response rate (ORR) of Anlotinib when administered in combination with fixed dose of irinotecan in advanced colorectal cancer patients.
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18 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
DCR
Tidsramme: 18 months
|
the disease control rate (DCR) of the combination of Anlotinib with Irinotecan in pretreated advanced colorectal cancer patients.
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18 months
|
PFS
Tidsramme: 18 months
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the progression free survival (PFS) of the combination of Anlotinib with Irinotecan in pretreated advanced colorectal cancer patients.
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18 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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 (Faktiske)
26. mai 2018
Primær fullføring (Forventet)
24. november 2019
Studiet fullført (Forventet)
24. november 2020
Datoer for studieregistrering
Først innsendt
23. mai 2018
Først innsendt som oppfylte QC-kriteriene
23. mai 2018
Først lagt ut (Faktiske)
4. juni 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. august 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. august 2018
Sist bekreftet
1. august 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer
- Neoplasmer etter nettsted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Kolonsykdommer
- Tarmsykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Kolorektale neoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Topoisomerasehemmere
- Topoisomerase I-hemmere
- Irinotekan
Andre studie-ID-numre
- NCC201803012
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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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