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

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Kartos Therapeutics

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Endometrial Cancer

Treatments

Drug: Navtemadlin Placebo
Drug: Navtemadlin

Study type

Interventional

Funder types

Other
NETWORK
Industry

Identifiers

NCT05797831
KRT-232-118
ENGOT en-21 (Other Identifier)
GOG-3089 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

268 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

268 participants in 7 patient groups, including a placebo group

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

Trial contacts and locations

83

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Central trial contact

John Mei

Data sourced from clinicaltrials.gov

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