AzTrials
AzTrials

Endometrial CancerPhase 2/3NCT05797831

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

A Phase 2/3 study testing Navtemadlin in people with Endometrial Cancer, run by Kartos Therapeutics, Inc. at 83 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Navtemadlin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
268 participants
Where
83 sitesin 17 countries
Study dates
17 Jul 2023to Jul 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

83 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

John Mei contact

650-542-0136

jmei@kartosthera.com

83 sites in 17 countries

United States19 sites, 19 recruiting

  • Northside Hospital

    Atlanta, Georgia, 30342

    Recruiting

  • Texas Oncology-Austin Central

    Austin, Texas, 78745

    Recruiting

  • OhioHealth Institute

    Columbus, Ohio, 43214

    Recruiting

  • Oncology Associates of Oregon

    Eugene, Oregon, 97401

    Recruiting

  • Parkview Research Center

    Fort Wayne, Indiana, 46845

    Recruiting

  • Texas Oncology-Fort Worth Cancer Center

    Fort Worth, Texas, 76104

    Recruiting

  • Dr. Sudarshan K. Sharma, Ltd.

    Hinsdale, Illinois, 60521

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Recruiting

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89106

    Recruiting

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

    Recruiting

  • FirstHealth Carolinas

    Pinehurst, North Carolina, 28374

    Recruiting

  • Northwest Cancer Specialists

    Portland, Oregon, 97227

    Recruiting

  • Texas Oncology-San Antonio Medical Center

    San Antonio, Texas, 78130

    Recruiting

  • St. Joseph

    Savannah, Georgia, 31405

    Recruiting

  • Maryland Oncology Hematology, P.A.

    Silver Spring, Maryland, 20904

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63108

    Recruiting

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma, 74146

    Recruiting

  • Kaiser Permanente Center

    Vallejo, California, 94589

    Recruiting

  • Good Samaritan Hospital Medical Center

    West Islip, New York, 11795

    Recruiting

Other trials in United States

Italy13 sites, 13 recruiting

  • A.O. Cannizzaro

    Catania, 95126

    Recruiting

  • IRCCS Istituto Romangolo per lo Studio dei Tumori "Dino Amadori"

    Forlì, 47014

    Recruiting

  • Ospedale Policlinico San Martino

    Genoa, 16132

    Recruiting

  • ASST di Lecco-Ospedale Alessandro Manzoni

    Lecco, 23900

    Recruiting

  • Ospedale San Luca

    Lucca, 55100

    Recruiting

  • Osp. Niguarda

    Milan, 20162

    Recruiting

  • University Hospital of Parma

    Parma, 43126

    Recruiting

  • Ospedale Guglielmo da Saliceto

    Piacenza, 29121

    Recruiting

  • Ospedale di Prato S. Stefano

    Prato, 59100

    Recruiting

  • Ospedale Santa Maria delle Croci

    Ravenna, 48121

    Recruiting

  • "Azienda Unità Sanitaria Locale della Romagna - Hospital ""Infermi"" of Rimini Oncology Department"

    Rimini, 47923

    Recruiting

  • Policlinico Umberto

    Rome, 00161

    Recruiting

  • Ospedale Filippo Del Ponte

    Varese, 21110

    Recruiting

Other trials in Italy

Poland9 sites, 9 recruiting

  • Białostockie Centrum Onkologii

    Bialystok, 15-027

    Recruiting

  • Szpitale Pomorskie

    Gdansk, 80-210

    Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

    Recruiting

  • NIO-PIB Oddzial w Gliwicach

    Gliwice, 44-102

    Recruiting

  • Centrum Badań klinicznych Jagiellońskie Centrum Innowacji

    Krakow, 31-115

    Recruiting

  • Siedleckie Centrum Onkologii

    Olsztyn, 10-228

    Recruiting

  • Uniwersytecki Szpital

    Poznan, 60-569

    Recruiting

  • NIO-PIB Klinika Gine-Onk

    Warsaw, 02-781

    Recruiting

  • Lower Silesian Oncology, Pulmonology and Hematology Center, Department of Oncological Gynecology

    Wroclaw, 53-413

    Recruiting

Other trials in Poland

Spain9 sites, 9 recruiting

  • CHUAC (Hospital de Coruña)

    A Coruña, 15006

    Recruiting

  • Hospital del Mar

    Barcelona, 08003

    Recruiting

  • Hospital Galdakao-Usansolo

    Galdakao, 48960

    Recruiting

  • Hospital Universitario de Jaen

    Jaén, 23007

    Recruiting

  • H.G.U. Jerez de la Frontera

    Jerez de la Frontera, 11407

    Recruiting

  • Hospital U Insular de GC

    Las Palmas, 35016

    Recruiting

  • Hospital de Leon

    León, 24008

    Recruiting

  • HCU Santiago de Compostela

    Santiago de Compostela, 15706

    Recruiting

  • Hospital Universitario de Valme

    Seville, 41014

    Recruiting

Other trials in Spain

Romania7 sites, 7 recruiting

  • Bucharest CF2 Hospital

    Bucharest, 012244

    Recruiting

  • Ovidius Clinical Hospital SRL

    Constanța, 905900

    Recruiting

  • Onco Clinic Consult S.A.

    Craiova, 200094

    Recruiting

  • Oncology Center "Sf. Nectarie"

    Craiova, 200542

    Recruiting

  • Gral Medical S.R.L. - Oncofort Hospital

    Piteşti, 110283

    Recruiting

  • Oncocenter, Oncology Clinic SRL

    Timișoara, 300166

    Recruiting

  • SC Oncomed SRL

    Timișoara, 300239

    Recruiting

Other trials in Romania

Austria3 sites, 3 recruiting

  • University Hospital Graz, Department of Gynecology and Obstetrics

    Graz, 8036

    Recruiting

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

    Recruiting

  • Medizinische Universität Wien

    Vienna, 1090

    Recruiting

Other trials in Austria

Georgia3 sites, 3 recruiting

  • LTD High Technology hospital Medcenter

    Batumi, 6000

    Recruiting

  • American Hospital Network LLC

    Tbilisi, 0102

    Recruiting

  • Caucasus Medical Centre

    Tbilisi, 0186

    Recruiting

Other trials in Georgia

Israel3 sites, 3 recruiting

  • Rambam Medical Center

    Haifa, Rambam Medical Center

    Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

    Recruiting

  • Sourasky Medical Center

    Tel Aviv, 6423906

    Recruiting

Other trials in Israel

Norway3 sites, 3 recruiting

  • Southern Hospital Sorlandet

    Kristiansand, 4604

    Recruiting

  • Oslo University Hospital HF

    Oslo, 0379

    Recruiting

  • Sykehusapotek Nord Tromsø

    Tromsø, 9038

    Recruiting

Other trials in Norway

Canada2 sites, 2 recruiting

  • Cross Cancer Institute

    Edmonton, T6G 1Z2

    Recruiting

  • CHUM - University of Montreal Hospital Centre

    Montreal, H2X 3E4

    Recruiting

Other trials in Canada

Finland2 sites, 2 recruiting

  • Kuopio University Hospital

    Kuopio, 70200

    Recruiting

  • Turku University Hospital

    Turku, 20520

    Recruiting

Other trials in Finland

Hungary2 sites, 2 recruiting

  • National Institute of Oncology

    Budapest, H-1122

    Recruiting

  • University of Debrecen Clinical Center

    Debrecen, 4032

    Recruiting

Other trials in Hungary

Lithuania2 sites, 2 recruiting

  • Health Sciences Kaunas Clinics

    Kaunas, LT-45434

    Recruiting

  • Nation Cancer Institute of Lithuania, Vilnius

    Vilnius, LT-08660

    Recruiting

Other trials in Lithuania

Slovenia2 sites, 2 recruiting

  • Institute of Oncology Ljubljana

    Ljubljana, 1000

    Recruiting

  • University Clinical Center Maribor

    Maribor, 2000

    Recruiting

Other trials in Slovenia

Sweden2 sites, 2 recruiting

  • Linkoping University Hospital

    Linköping, 581 85

    Recruiting

  • Karolinska University Hospital

    Stockholm, SE-171 76

    Recruiting

Other trials in Sweden

Denmark1 site, 1 recruiting

  • Odense University Hospital

    Odense, DK-5000

    Recruiting

Other trials in Denmark

Estonia1 site, 1 recruiting

  • Tartu University Hospital

    Tartu, 50406

    Recruiting

Other trials in Estonia

About this study

Official title: A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy

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.

Being tested
Navtemadlin, Navtemadlin Placebo
Keywords
navtemadlin
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NavtemadlinDrug

    Also called KRT-232

    Navtemadlin is an experimental MDM2 anticancer drug taken by mouth

  • Navtemadlin PlaceboDrug

    Navtemadlin placebo is a placebo that is the same in appearance to navtemadlin drug taken by mouth

Study groups in NCT05797831
Study groupRoleWhat they receive
Part 1 Arm 1ExperimentalNavtemadlin administered orally at 180 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
Receives: Drug: Navtemadlin
Part 1 Arm 2ExperimentalNavtemadlin administered orally at 240 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
Receives: Drug: Navtemadlin
Part 1 Arm 3No interventionObservational control ("watch and wait") on a 28-day cycle.
Part 2 Arm AExperimentalNavtemadlin administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
Receives: Drug: Navtemadlin
Part 2 Arm BExperimentalNavtemadlin administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
Receives: Drug: Navtemadlin
Part 2 Arm CPlacebo comparatorPlacebo administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.
Receives: Drug: Navtemadlin Placebo
Part 2 Arm DPlacebo comparatorPlacebo administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.
Receives: Drug: Navtemadlin Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: To determine the navtemadlin Phase 3 dose

    Safety review committee (SRC) will determine the navtemadlin Phase 3 dose for Part 2 based on safety data from Part 1

    Measured: 12 months

  2. Part 2: To compare progression-free (PFS) survival by independent review committee (IRC) between navtemadlin and placebo

    PFS defined as the time from randomization to disease progression by IRC or death, whichever occurs first

    Measured: 50 months

Secondary outcomes (6)

  1. Part 1: To evaluate the treatment effect of navtemadlin on PFS by IRC and investigator assessment

    PFS defined as the time from randomization to disease progression by IRC/investigator assessment or death, whichever occurs first

    Measured: 50 months

  2. Part 2: To evaluate the treatment effect of navtemadlin on the time to first subsequent treatment (TFST)

    TFST defined as the time from randomization to initiation of first subsequent anticancer therapy or death, whichever occurs first

    Measured: 50 months

  3. Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin

    Will determine the Maximum observed concentration (Cmax)

    Measured: 1 day

  4. Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin

    Will determine the area under the plasma concentration versus time curve (AUC)

    Measured: 1 day

  5. Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin

    Will determine the time of maximum plasma concentration (Tmax)

    Measured: 1 day

  6. Parts 1 and 2: To evaluate the treatment effect of navtemadlin on the disease control rate (DCR)

    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

    Measured: 50 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start17 Jul 2023
  3. Primary completionAug 2025 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
268 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05797831
Sponsor's protocol ID
KRT-232-118
Other IDs
ENGOT en-21, GOG-3089
Status last verified
Apr 2024
First submitted
7 Mar 2023
Last updated
2 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Navtemadlin in people with Endometrial Cancer, run by Kartos Therapeutics, Inc. at 83 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Italy, Poland, Spain, Romania and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact John Mei (650-542-0136, jmei@kartosthera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: To determine the navtemadlin Phase 3 dose (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05797831.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in