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Nab-paclitaxel/m^2

Phase 3

Ovarian Neoplasm | Small molecule | Oncology |Corcept Therapeutics Incorporated|Last Updated: Apr 16, 2025

Target and mechanism

ModalitySmall molecule

Also known as Nab-paclitaxel

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment381

FDA Designations

No designations recorded

Clinical trial landscape

Nab-paclitaxel/m^2 · 1 trial · 3 indications

Phase 3 1
NCT05257408Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube CancerOvarian Neoplasm
ACTIVE NOT_RECRUITING381 Analytics
PHASE3ACTIVE NOT_RECRUITING
Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer
Ovarian NeoplasmUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free Survival as Assessed by BICR
Up to 24 months from enrollment of the last patient

Time from randomization until the time of first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause, whichever occurs first

Overall survival
Up to 24 months from enrollment of the last patient

Time from randomization to death by any cause

Secondary Endpoints

PFS as Assessed by the Investigator
Up to 24 months from enrollment of the last patient
Objective Response as Assessed by BICR
Up to 24 months from enrollment of the last patient
Best Overall Response as Assessed by BICR
Up to 24 months from enrollment of the last patient
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Nab-paclitaxel 80 mg/m^2 with Relacorilant 150 mgEXPERIMENTALPatients receive nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle in combination with intermittent relacorilant (150 mg relacorilant once daily on the day before, the day of, and the day after nab-paclitaxel), administered orally under fed conditions. Relacorilant will not be administered on Cycle 1 Day -1.
Nab-paclitaxel 100 mg/m^2ACTIVE_COMPARATORPatients receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle.

Interventions

NameTypeDescription
Nab-paclitaxel 80 mg/m^2DRUGNab-paclitaxel is administered as intravenous (IV) infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant 150 mg once daily (QD)DRUGRelacorilant is administered as capsules for oral dosing.
Nab-paclitaxel 100 mg/m^2DRUGNab-paclitaxel is administered as IV infusion on Day 1, 8, and 15 of each 28-day cycle.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites117

Inclusion Criteria: * Signed and dated Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to study-specific screening procedures. * Confirmed histologic diagnosis of high-grade (Grade 3) serous, epithelial ovarian, primary peritoneal, or fallopian tube carc...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaFranceHungaryIsraelItalyPolandSouth KoreaSpainUnited Kingdom
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Frequently asked questions about Nab-paclitaxel/m^2

What is Nab-paclitaxel/m^2 used for?

Nab-paclitaxel/m^2 is being studied for the treatment of ovarian neoplasms, specifically advanced, platinum-resistant, high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer. It is an investigational small molecule in Phase 3 clinical development, and it is not yet approved by the FDA.

What does Nab-paclitaxel/m^2 target?

Nab-paclitaxel/m^2 is a small molecule that is being evaluated in combination with relacorilant. The specific molecular target of Nab-paclitaxel/m^2 is not disclosed in the available information, so its mechanism of action is not described here.

Who makes Nab-paclitaxel/m^2?

Nab-paclitaxel/m^2 is being developed by Corcept Therapeutics Incorporated, a company traded on the NASDAQ under the ticker symbol CORT. The drug is currently in Phase 3 clinical trials for ovarian cancer.

What phase is Nab-paclitaxel/m^2 in?

Nab-paclitaxel/m^2 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 3 trial is active but not recruiting participants.

What clinical trials is Nab-paclitaxel/m^2 in?

Nab-paclitaxel/m^2 is being studied in a Phase 3 trial with the identifier NCT05257408. This randomized, active-controlled trial enrolls 381 female participants aged 18 years and older with advanced, platinum-resistant, high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer. The trial is active but not recruiting.

Is Nab-paclitaxel/m^2 the same as Nab-paclitaxel 80 mg/m^2?

Yes, Nab-paclitaxel/m^2 is also known as Nab-paclitaxel 80 mg/m^2 and Nab-paclitaxel. These names refer to the same drug being developed by Corcept Therapeutics for the treatment of ovarian cancer.