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JOURNAL ONKOLOGIE – STUDIE

Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer

Rekrutierend

NCT-Nummer:
NCT05797831

Studienbeginn:
Juli 2023

Letztes Update:
02.05.2024

Wirkstoff:
Navtemadlin, Navtemadlin Placebo

Indikation (Clinical Trials):
Endometrial Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Kartos Therapeutics, Inc.

Collaborator:
European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation,

Kontakt

Studienlocations
(3 von 83)

Brustzentrum St. Joseph-Stift Bremen
Schwachhauser Heerstraße 54
28209 Bremen
DeutschlandRekrutierend» Google-Maps
Kaiser Permanente Center
94589 Vallejo
United StatesRekrutierend» Google-Maps
Dr. Sudarshan K. Sharma, Ltd.
60521 Hinsdale
United StatesRekrutierend» Google-Maps
Parkview Research Center
46845 Fort Wayne
United StatesRekrutierend» Google-Maps
Indiana University
46202 Indianapolis
United StatesRekrutierend» Google-Maps
Maryland Oncology Hematology, P.A.
20904 Silver Spring
United StatesRekrutierend» Google-Maps
Minnesota Oncology Hematology, P.A.
55404 Minneapolis
United StatesRekrutierend» Google-Maps
Washington University School of Medicine
63108 Saint Louis
United StatesRekrutierend» Google-Maps
Women's Cancer Center of Nevada
89106 Las Vegas
United StatesRekrutierend» Google-Maps
Good Samaritan Hospital Medical Center
11795 West Islip
United StatesRekrutierend» Google-Maps
FirstHealth Carolinas
28374 Pinehurst
United StatesRekrutierend» Google-Maps
Oklahoma Cancer Specialists and Research Institute
74146 Tulsa
United StatesRekrutierend» Google-Maps
Oncology Associates of Oregon
97401 Eugene
United StatesRekrutierend» Google-Maps
Northwest Cancer Specialists
97227 Portland
United StatesRekrutierend» Google-Maps
Texas Oncology-Austin Central
78745 Austin
United StatesRekrutierend» Google-Maps
Texas Oncology-Fort Worth Cancer Center
76104 Fort Worth
United StatesRekrutierend» Google-Maps
Texas Oncology-San Antonio Medical Center
78130 San Antonio
United StatesRekrutierend» Google-Maps
University Hospital Graz, Department of Gynecology and Obstetrics
8036 Graz
AustriaRekrutierend» Google-Maps
Medizinische Universität Innsbruck
6020 Innsbruck
AustriaRekrutierend» Google-Maps
Medizinische Universität Wien
1090 Vienna
AustriaRekrutierend» Google-Maps
CHUM - University of Montreal Hospital Centre
H2X 3E4 Montreal
CanadaRekrutierend» Google-Maps
LTD High Technology hospital Medcenter
6000 Batumi
GeorgiaRekrutierend» Google-Maps
American Hospital Network LLC
0102 Tbilisi
GeorgiaRekrutierend» Google-Maps
National Institute of Oncology
H-1122 Budapest
HungaryRekrutierend» Google-Maps
University of Debrecen Clinical Center
4032 Debrecen
HungaryRekrutierend» Google-Maps
Rambam Medical Center
Rambam Medical Center Haifa
IsraelRekrutierend» Google-Maps
Shaare Zedek Medical Center
9103102 Jerusalem
IsraelRekrutierend» Google-Maps
IRCCS Istituto Romangolo per lo Studio dei Tumori "Dino Amadori"
47014 Forli
ItalyRekrutierend» Google-Maps
Ospedale Policlinico San Martino
16132 Genoa
ItalyRekrutierend» Google-Maps
ASST di Lecco-Ospedale Alessandro Manzoni
23900 Lecco
ItalyRekrutierend» Google-Maps
Ospedale Guglielmo da Saliceto
29121 Piacenza
ItalyRekrutierend» Google-Maps
Ospedale Santa Maria delle Croci
48121 Ravenna
ItalyRekrutierend» Google-Maps
"Azienda Unità Sanitaria Locale della Romagna - Hospital ""Infermi"" of Rimini Oncology Department"
47923 Rimini
ItalyRekrutierend» Google-Maps
Health Sciences Kaunas Clinics
LT-45434 Kaunas
LithuaniaRekrutierend» Google-Maps
Nation Cancer Institute of Lithuania, Vilnius
LT-08660 Vilnius
LithuaniaRekrutierend» Google-Maps
Southern Hospital Sorlandet
4604 Kristiansand
NorwayRekrutierend» Google-Maps
Białostockie Centrum Onkologii
15-027 Bialystok
PolandRekrutierend» Google-Maps
Uniwersyteckie Centrum Kliniczne
80-214 Gdańsk
PolandRekrutierend» Google-Maps
Centrum Badań klinicznych Jagiellońskie Centrum Innowacji
31-115 Kraków
PolandRekrutierend» Google-Maps
Siedleckie Centrum Onkologii
10-228 Olsztyn
PolandRekrutierend» Google-Maps
Lower Silesian Oncology, Pulmonology and Hematology Center, Department of Oncological Gynecology
53-413 Wroclaw
PolandRekrutierend» Google-Maps
Ovidius Clinical Hospital SRL
905900 Constanta
RomaniaRekrutierend» Google-Maps
Oncology Center "Sf. Nectarie"
200542 Craiova
RomaniaRekrutierend» Google-Maps
Gral Medical S.R.L. - Oncofort Hospital
110283 Piteşti
RomaniaRekrutierend» Google-Maps
Oncocenter, Oncology Clinic SRL
300166 Timisoara
RomaniaRekrutierend» Google-Maps
Institute of Oncology Ljubljana
1000 Ljubljana
SloveniaRekrutierend» Google-Maps
University Clinical Center Maribor
2000 Maribor
SloveniaRekrutierend» Google-Maps
H.G.U. Jerez de la Frontera
11407 Jerez de la Frontera
SpainRekrutierend» Google-Maps
HCU Santiago de Compostela
15706 Santiago de Compostela
SpainRekrutierend» Google-Maps
Hospital Universitario de Valme
41014 Seville
SpainRekrutierend» Google-Maps
Linkoping University Hospital
581 85 Linköping
SwedenRekrutierend» Google-Maps
Karolinska University Hospital
SE-171 76 Stockholm
SwedenRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This study evaluates navtemadlin as maintenance treatment for patients with advanced or

recurrent endometrial cancer (EC) who have achieved complete response or partial response on

chemotherapy.

The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two

different doses of navtemadlin alongside an observational control arm to determine the Phase

3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose

compared to placebo.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- ECOG 0-1

- Histologically or cytologically confirmed diagnosis of endometrial cancer documented

as TP53WT

- Subjects with advanced or recurrent disease must have completed a single line of up to

6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1

- Adequate hematologic, hepatic and renal function (within 14 days)

Exclusion Criteria:

- Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation

- Prior immune therapy, cytokine therapy, or any investigational therapy (within 28

days)

- Indwelling surgical drains

- Grade 2 or higher QTc prolongation

- History of major organ transplant

- History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24

weeks)

Studien-Rationale

Primary outcome:

1. Part 1: To determine the navtemadlin Phase 3 dose (Time Frame - 12 months):
Safety review committee (SRC) will determine the navtemadlin Phase 3 dose for Part 2 based on safety data from Part 1

2. Part 2: To compare progression-free (PFS) survival by independent review committee (IRC) between navtemadlin and placebo (Time Frame - 50 months):
PFS defined as the time from randomization to disease progression by IRC or death, whichever occurs first

Secondary outcome:

1. Part 1: To evaluate the treatment effect of navtemadlin on PFS by IRC and investigator assessment (Time Frame - 50 months):
PFS defined as the time from randomization to disease progression by IRC/investigator assessment or death, whichever occurs first

2. Part 2: To evaluate the treatment effect of navtemadlin on the time to first subsequent treatment (TFST) (Time Frame - 50 months):
TFST defined as the time from randomization to initiation of first subsequent anticancer therapy or death, whichever occurs first

3. Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin (Time Frame - 1 day):
Will determine the Maximum observed concentration (Cmax)

4. Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin (Time Frame - 1 day):
Will determine the area under the plasma concentration versus time curve (AUC)

5. Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin (Time Frame - 1 day):
Will determine the time of maximum plasma concentration (Tmax)

6. Parts 1 and 2: To evaluate the treatment effect of navtemadlin on the disease control rate (DCR) (Time Frame - 50 months):
Best response of complete response (CR), partial response (PR) or stable disease (SD) by IRC/investigator assessment among subjects with PR as best response from prior chemotherapy

Studien-Arme

  • Experimental: Part 1 Arm 1
    Navtemadlin administered orally at 180 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
  • Experimental: Part 1 Arm 2
    Navtemadlin administered orally at 240 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
  • No Intervention: Part 1 Arm 3
    Observational control ("watch and wait") on a 28-day cycle.
  • Experimental: Part 2 Arm A
    Navtemadlin administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
  • Experimental: Part 2 Arm B
    Navtemadlin administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
  • Placebo Comparator: Part 2 Arm C
    Placebo administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.
  • Placebo Comparator: Part 2 Arm D
    Placebo administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.

Geprüfte Regime

  • Navtemadlin (KRT-232):
    Navtemadlin is an experimental MDM2 anticancer drug taken by mouth
  • Navtemadlin Placebo:
    Navtemadlin placebo is a placebo that is the same in appearance to navtemadlin drug taken by mouth

Quelle: ClinicalTrials.gov


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