- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03780010
Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC
4. oktober 2019 opdateret af: Tracon Pharmaceuticals Inc.
A Phase 1b Dose-escalation Study of TRC105 in Combination With Paclitaxel/Carboplatin and Bevacizumab in Patients With Stage 4 Non-Squamous Cell Lung Cancer
This is a single center, open-label, nonrandomized, phase 1b, dose-finding study of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
Studieoversigt
Detaljeret beskrivelse
Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that inhibits angiogenesis and extends survival in non-squamous non-small cell lung cancer (NSCLC) patients when given with carboplatin and paclitaxel.
TRC105 is an antibody to endoglin, an essential angiogenic target expressed on proliferating endothelial cells that is distinct from the VEGFR and overexpressed in response to VEGF inhibition.
TRC105 inhibits angiogenesis, tumor growth and metastases in preclinical models and complements the activity of antibodies and small molecules that target the VEGFR.
In a phase 1b study, the combination of TRC105 and bevacizumab produced radiographic reductions in tumor volume in bevacizumab-refractory patients, and was well tolerated.
TRC105 was also well tolerated with chemotherapy in a trial with capecitabine in breast cancer patients.
The use of TRC105 with bevacizumab and paclitaxel/carboplatin may result in more effective angiogenesis inhibition and improved clinical efficacy over that seen with bevacizumab and paclitaxel/carboplatin alone.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
15
Fase
- Fase 1
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
Key Inclusion Criteria:
- Stage 4 Non-Squamous Cell Lung Cancer that has not been treated previously with systemic chemotherapy or bevacizumab, but may have received prior targeted treatment (e.g., alk1 inhibitor)
- ECOG performance status ≤ 1
- Measurable disease by RECIST
Key Exclusion Criteria:
- Non-small cell lung cancer of squamous histology
- Current treatment on another therapeutic clinical trial
- Patients who have received wide field radiotherapy ≤ 28 days (defined as > 50% of volume of pelvic bones or equivalent) or limited field radiation for palliation < 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy
- Active bleeding or pathologic condition that carries a high risk of bleeding (e.g. hereditary hemorrhagic telangiectasia). Patients who have been uneventfully anti-coagulated with low molecular weight heparin are eligible.
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: TRC105 + B + P + C
TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
|
Dose-finding study of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Treatment-Emergent Adverse Events
Tidsramme: from screening until completion of follow-up, on average 6 months
|
Incidence of treatment-emergent (i.e.
TRC105, bevacizumab, paclitaxel and/or carboplatin) adverse events by CTCAE v4.03
|
from screening until completion of follow-up, on average 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Overall RECIST 1.1 Response Rate
Tidsramme: 6 months
|
Response rate determined according to RECIST 1.1 criteria
|
6 months
|
Percent of Patients With Progression-free Survival (PFS) at 6 Months
Tidsramme: 6 months
|
Number of patients with progression-free survival at 6 months determined according to RECIST 1.1 criteria
|
6 months
|
Median Progression Free Survival
Tidsramme: months
|
Median duration of progression free survival according to RECIST 1.1 criteria
|
months
|
Pharmacokinetic Profile of TRC105 When Given With Bevacizumab and Paclitaxel/Carboplatin
Tidsramme: 3 months
|
Trough serum TRC105 pharmacokinetic concentrations at steady state (cycle 3 day 1) will be measured using validated ELISA methods.
|
3 months
|
Number of Patients Who Have TRC105 Positive Anti-Product Antibodies
Tidsramme: 6 months
|
Anti-product antibody concentrations will be measured using validated ELISA methods.
Anti-product antibody concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles.
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Charles Theuer, MD, TRACON Pharmaceuticals
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 (Faktiske)
1. september 2015
Primær færdiggørelse (Faktiske)
1. juni 2019
Studieafslutning (Faktiske)
1. juni 2019
Datoer for studieregistrering
Først indsendt
13. november 2018
Først indsendt, der opfyldte QC-kriterier
17. december 2018
Først opslået (Faktiske)
19. december 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. oktober 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. oktober 2019
Sidst verificeret
1. oktober 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Lungeneoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Carboplatin
- Paclitaxel
Andre undersøgelses-id-numre
- 105LC101
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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 Ikke småcellet lungekræft
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AHS Cancer Control AlbertaCross Cancer InstituteAfsluttetOmfattende Stage Small Cel Lung CancerCanada
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Universitaire Ziekenhuizen KU LeuvenUkendtLymfom | Hodgkin lymfom | Non-Hodgkin lymfom (follikulært, diffust B-cel lymfom, PTLD og Mantle Cel lymfom)Belgien
Kliniske forsøg med TRC105
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National Cancer Institute (NCI)AfsluttetUrothelialt karcinom | Ureterale neoplasmer | Ureterkræft | Kræft i urinlederen | Neoplasma, UreteralForenede Stater
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National Cancer Institute (NCI)AfsluttetProstatakræft | Metastatisk kastrat-resistent prostatakræftForenede Stater
-
Tracon Pharmaceuticals Inc.AfsluttetÆggelederkarcinom | Primært peritonealt karcinom | Tilbagevendende kræft i æggestokkeneForenede Stater
-
National Cancer Institute (NCI)AfsluttetCarcinom, hepatocellulært | Hepatocellulært karcinom | Hepatocellulær kræftForenede Stater
-
Tracon Pharmaceuticals Inc.AfsluttetNyrecellekarcinomForenede Stater, Ungarn, Tjekkiet, Det Forenede Kongerige
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University of Alabama at BirminghamTracon Pharmaceuticals Inc.Afsluttet
-
Tracon Pharmaceuticals Inc.AfsluttetChoriocarcinomForenede Stater
-
Tracon Pharmaceuticals Inc.AfsluttetAvanceret angiosarkomForenede Stater, Frankrig, Italien, Østrig, Tyskland, Polen, Spanien, Det Forenede Kongerige
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Tracon Pharmaceuticals Inc.AfsluttetKarcinom, ikke-småcellet lungeForenede Stater
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Tracon Pharmaceuticals Inc.Afsluttet