- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01332721
Study of TRC105 Combined With Standard-Dose Bevacizumab for Advanced Solid Tumors for Which Bevacizumab is Indicated
7. november 2018 opdateret af: Tracon Pharmaceuticals Inc.
An Open Label Phase 1B Dose-Escalation Study of TRC105 Combined With Standard-Dose Bevacizumab for Advanced Solid Tumors
The purpose of the study is to evaluate safety and tolerability and determine a recommended Phase 2 dose for TRC105 when added to standard dose bevacizumab in patients with advanced solid tumors for which bevacizumab is indicated.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that inhibits angiogenesis and extends survival in patients with a wide variety of solid tumor types.
TRC105, a monoclonal antibody to CD105, is a novel angiogenesis inhibitor that complements bevacizumab in preclinical models.
Together, these antibodies may result in more effective angiogenesis inhibition and improved clinical efficacy over that seen with bevacizumab alone.
The purpose of the study is to evaluate safety and tolerability and determine a recommended Phase 2 dose for TRC105 when added to standard dose bevacizumab in patients with advanced solid tumors for which bevacizumab is indicated.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
38
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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Alabama
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Birmingham, Alabama, Forenede Stater, 35249
- University of Alabama at Birmingham
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85258
- Pinnacle Oncology Hematology
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California
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Santa Monica, California, Forenede Stater, 90404
- UCLA Hematology and Oncology
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University Simon Cancer Center
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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:
- Histologically proven advanced or metastatic solid cancer
- Measurable disease, evaluable disease or elevation of a relevant soluble tumor marker (e.g., CEA, PSA, CA125)
- Age of 18 years or older
- ECOG performance status of 0 or 1
- Resolution of all acute AEs resulting from prior cancer therapies to NCI CTCAE Grade ≤ 1 or baseline (except alopecia)
- Adequate organ function
- Willing and able to consent for self to participate in study
Exclusion Criteria:
- Prior treatment with TRC105
- Serious dose-limiting toxicity related to prior bevacizumab
- Current treatment on another therapeutic clinical trial
- Receipt of an investigational agent within 28 days of starting study treatment
- Prior surgery (including open biopsy) within 28 days of starting the study treatment
- Prior radiation therapy or systemic therapy within 21 days of starting the study treatment
- Minor surgical procedures such as fine needle aspirations, Mediport placement or core biopsies within 7 days of study treatment
- Uncontrolled chronic hypertension defined as systolic > 140 or diastolic > 90 despite optimal therapy (initiation or adjustment of BP medication prior to study entry allowed provided that the average of 3 BP readings at a visit prior to enrollment is < 140/90 mm Hg)
- Symptomatic pericardial or pleural effusions
- Uncontrolled peritoneal effusions requiring paracentesis more frequently than every 2 weeks
- History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease (except in the expansion cohort at the MTD where brain metastases or primary brain tumors are eligible)
- Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, DVT, PTCA or CABG within the past 6 months
- Active bleeding or pathologic condition that carries a high risk of bleeding
- Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy
- Cardiac dysrhythmias of NCI CTCAE Grade ≥ 2 within the last 28 days
- Known active viral or nonviral hepatitis
- Centrally located non-small cell lung cancer (regardless of histologic sub-type), or non-small cell lung cancer of squamous histology.
- History of hemorrhage or hemoptysis (>½ teaspoon bright red blood) within 6 months of starting study treatment
- Open wounds or unhealed fractures within 28 days of starting study treatment
- History of peptic ulcer disease or erosive gastritis within the past 6 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
- Pregnancy or breastfeeding
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: TRC105 and Bevacizumab
Escalating doses of i.v.
TRC105 will be administered weekly beginning with 3 mg/kg in combination with 15 mg/kg bevacizumab given every 3 weeks.
Patients will receive TRC105 treatment on Days 1, 8, and 15 and bevacizumab treatment on Day 1 of each 21-day cycle.
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Escalating doses of i.v.
TRC105 will be administered weekly beginning with 3 mg/kg in combination with 15 mg/kg bevacizumab given every 3 weeks.
Patients will receive TRC105 treatment on Days 1, 8, and 15 and bevacizumab treatment on Day 1 of each 21-day cycle.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Determine Maximum Tolerated Dose of TRC105 in Combination With Bevacizumab
Tidsramme: 1.5 years
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Three patients will be initially enrolled and treated at each dose level.
If none of these 3 patients experiences a dose-limiting toxicity (DLT) during the 28-day evaluation period, dose escalation will proceed following review of safety data with appropriate site staff including the principal investigators at all sites.
If 1 of 3 patients experiences DLT, the cohort will be expanded to 6 patients.
The maximum tolerated dose (MTD) will have been exceeded if ≥ 33% of patients experience DLT in a given cohort.
DLT will have occurred when a patient has 1 or more toxicity listed in the table below that is at least possibly related to the combination of bevacizumab and TRC105 during the first 28 days (cycle 1).
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1.5 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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TRC105 Pharmacokinetic Concentrations
Tidsramme: 1.5 years
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Plasma TRC105 concentrations will be measured at specified timepoints.
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1.5 years
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Immune Response to TRC105
Tidsramme: 1.5 years
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HAMA and HACA titers will be measured at specified time-points.
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1.5 years
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Objective Response According to RECIST 1.1
Tidsramme: 1.5 years
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The best response according to RECIST 1.1 for each patient with measurable disease and who received at least one dose of study drug will be listed by cohort and tumor type
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1.5 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Charles P Theuer, MD, Tracon Pharmaceuticals Inc.
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. april 2011
Primær færdiggørelse (Faktiske)
1. september 2012
Studieafslutning (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
7. april 2011
Først indsendt, der opfyldte QC-kriterier
8. april 2011
Først opslået (Skøn)
11. april 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. december 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. november 2018
Sidst verificeret
1. november 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 105ST102
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 Voksen fast tumor
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Memorial Sloan Kettering Cancer CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater, Puerto Rico
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater, Puerto Rico
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Sorrento Therapeutics, Inc.Trukket tilbageSolid tumor | Recidiverende solid tumor | Refraktær tumor
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Impact Therapeutics, Inc.RekrutteringSolid tumor | Avanceret solid tumorKina, Taiwan, Forenede Stater, Australien
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Partner Therapeutics, Inc.Trukket tilbageSolid tumor | Solid tumor, voksenForenede Stater
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BeiGeneRekrutteringSolid tumor | Avanceret solid tumorForenede Stater, New Zealand, Australien, Kina
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Anjali PawarRekrutteringSolid tumor | Solid tumor, barndomForenede Stater
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Pyxis Oncology, IncRekrutteringSolid tumor | Avanceret solid tumorForenede Stater, Spanien, Belgien
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Neurogene Inc.Merck Sharp & Dohme LLCAktiv, ikke rekrutterendeSolid tumor | Avanceret solid tumorForenede Stater, Australien, Canada
Kliniske forsøg med TRC105 and Bevacizumab
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Tracon Pharmaceuticals Inc.AfsluttetChoriocarcinomForenede Stater
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National Cancer Institute (NCI)AfsluttetUrothelialt karcinom | Ureterale neoplasmer | Ureterkræft | Kræft i urinlederen | Neoplasma, UreteralForenede Stater
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Tracon Pharmaceuticals Inc.AfsluttetGestationel trofoblastisk neoplasi | Choriocarcinom | Trofoblastisk tumor på placentastedet | Epiteloid trofoblastisk tumorForenede Stater
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Tracon Pharmaceuticals Inc.The Cleveland Clinic; Case Comprehensive Cancer CenterAfsluttetGlioblastom | Glioblastoma MultiformeForenede Stater
-
National Cancer Institute (NCI)AfsluttetProstatakræft | Metastatisk kastrat-resistent prostatakræftForenede Stater
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Tracon Pharmaceuticals Inc.AfsluttetÆggelederkarcinom | Primært peritonealt karcinom | Tilbagevendende kræft i æggestokkeneForenede Stater
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Tracon Pharmaceuticals Inc.Ikke længere tilgængeligFaste tumorerForenede Stater
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National Cancer Institute (NCI)AfsluttetCarcinom, hepatocellulært | Hepatocellulært karcinom | Hepatocellulær kræftForenede Stater
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Tracon Pharmaceuticals Inc.AfsluttetNyrecellekarcinomForenede Stater, Ungarn, Tjekkiet, Det Forenede Kongerige
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University of Alabama at BirminghamTracon Pharmaceuticals Inc.Afsluttet