- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00852189
Study of EC0489 for the Treatment of Refractory or Metastatic Tumors
A Phase I Study of EC0489 Administered Weeks 1 and 3 of a 4-Week Cycle
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a Phase 1, dose escalation study of EC0489 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle in PART A and weekly on a 4-week cycle in PART B.
Both Parts are open to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0489 is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of EC0489; however, lab research (research in test tubes or animals) using EC0489 has shown activity against tumors in animals. This activity in animal models suggests that EC0489 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0489 given by intravenous bolus. The efficacy of treatment will also be measured.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
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Indiana
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Lafayette, Indiana, Forenede Stater, 47905
- Horizon Oncology Center
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- Greenebaum Cancer Center - University of Maryland
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Bethesda, Maryland, Forenede Stater, 20817
- Center For Cancer And Blood Disorders
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Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Barbara Ann Karmanos Cancer Institute - Wayne State University
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Lansing, Michigan, Forenede Stater, 48910
- Great Lakes Cancer Institute - Michigan State University
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Southfield, Michigan, Forenede Stater, 48075
- Providence Cancer Institute
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 18 years of age or older
- Histological or cytological diagnosis of neoplasm
- No effective standard therapeutic options
- ECOG performance status of 0-2
- ≥ 4 weeks post therapeutic radiation or recovered (or returned to baseline) from any acute toxicity associated with prior cytotoxic therapy. Patients previously treated with non-cytotoxic therapy (e.g., EGFR, VGEF, etc.) and who have recovered from or have controlled drug-associated toxicity are allowed to enter the trial after a period consisting of 4 half-lives of the agent.
- Negative serum pregnancy test for women of child-bearing potential within one week prior to treatment with investigational agents (99mTc-EC20 and EC0489)and willingness to practice contraceptive methods
- Adequate bone marrow reserve, renal and hepatic function
Exclusion Criteria:
- Concurrent malignancies
- Women who are pregnant or breast-feeding
- Evidence of symptomatic brain metastases
- Receiving concomitant anticancer therapy (excluding supportive care)
- Requires palliative radiotherapy at time of study entry
- Requires antifolate therapy for comorbid conditions
- Heart failure characterized as greater than NYHA Class I
- History of myocardial infarct
- Any of the following baseline echocardiogram findings: valvular lesions (stenosis or insufficiency) characterized as greater than moderate, systolic ventricular impairment characterized as greater than mild, left ventricular ejection fraction < 55%, any feature of the echocardiogram that would confound interpretation of the serial echocardiograms required by the protocol
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Maksimal tolereret dosis (MTD)
Tidsramme: Dosiseskalering til den højeste dosis, der sikkert kan administreres for at frembringe acceptabel, håndterbar og reversibel toksicitet hos højst 0 eller 1 ud af 6 patienter
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Dosiseskalering til den højeste dosis, der sikkert kan administreres for at frembringe acceptabel, håndterbar og reversibel toksicitet hos højst 0 eller 1 ud af 6 patienter
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Farmakokinetiske og farmakodynamiske parametre
Tidsramme: Opnået under den første behandlingscyklus på dag 1 og 3
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Opnået under den første behandlingscyklus på dag 1 og 3
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Anti-tumor aktivitet
Tidsramme: Indledende dosis af studieterapi til sygdomsprogression
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Indledende dosis af studieterapi til sygdomsprogression
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Uptake of 99mTc-EC20 in tumors and normal tissues
Tidsramme: 1-2 hours post administration of 99mTc-EC20
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1-2 hours post administration of 99mTc-EC20
|
Safety and Tolerability
Tidsramme: Initiation of study therapy through 30 day post last dose of study therapy
|
Initiation of study therapy through 30 day post last dose of study therapy
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Richard A Messmann, MD, MHS, MSc, Endocyte
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EC-0489-01
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Kliniske forsøg med EC0489, Injection
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Jiangsu HengRui Medicine Co., Ltd.Ikke rekrutterer endnu
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Beijing Boren HospitalAfsluttetAvanceret solid tumor | Recidiverende/refraktær lymfomKina
-
Staidson (Beijing) Biopharmaceuticals Co., LtdRekrutteringAcute respiratory distress syndromKina
-
Ruijin HospitalShanghai Essight Bio Co.,LtdRekruttering
-
Jiangsu Kanion Pharmaceutical Co., LtdBeijing Bionovo Medicine Development Co., Ltd.Afsluttet
-
Bio-Thera SolutionsAfsluttet
-
Shengjing HospitalJiangsu HengRui Medicine Co., Ltd.Ikke rekrutterer endnuER Positiv/HER2 lav brystkræftKina
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Jeffrey S HeierKato Pharmaceuticals, Inc.AfsluttetVitreomakulær trækkraft | Vitreomakulær vedhæftning | Vitreomakulær vedhæftningForenede Stater
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GE HealthcareRekrutteringOnkologi | Ondartet fast tumorHolland
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UTC Therapeutics Inc.Peking University Cancer Hospital & InstituteRekrutteringKolorektal cancer | Kræft i bugspytkirtlen | Endetarmskræft | Malignt mesotheliom | Galdevejskræft | Brystkræft kvinde | Kræft i æggestokkeneKina