NCT03268382

Brief Summary

The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and PLD chemotherapy regimen in patients with platinum-resistant recurrent high grade serous ovarian cancer (HGSOC) with mutated TP53. In addition, the study aims to assess the safety profile of the combined APR-246 and PLD chemotherapy regimen, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll at least 25 evaluable patients.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2017

Geographic Reach
3 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
3 years until next milestone

Results Posted

Study results publicly available

July 21, 2022

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

1.9 years

First QC Date

August 24, 2017

Results QC Date

June 1, 2022

Last Update Submit

March 6, 2025

Conditions

High-grade Serous Ovarian Cancer

Keywords

Ovarian CancerOvarian CarcinomaHigh Grade Serous Ovarian CancerRecurrent CancerResistant Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate (ORR)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Up to 18 months

Secondary Outcomes (1)

  • Treatment-emergent Adverse Events With Combined APR-246 and PLD Regimen

    Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)

Study Arms (1)

APR-246 + PLD

EXPERIMENTAL
Drug: APR-246Drug: Pegylated Liposomal Doxorubicin Hydrochloride (PLD)

Interventions

APR-246DRUG

Intravenous infusion

APR-246 + PLD
Pegylated Liposomal Doxorubicin Hydrochloride (PLD)DRUG

Intravenous infusion

APR-246 + PLD

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed High Grade Serous Ovarian Cancer, and positive nuclear immunohistochemical (IHC) staining for p53
  • Disease Progression between 4 weeks - 6 months after the last platinum-based treatment was administered
  • At least a single measurable lesion
  • Adequate organ function prior to registration
  • Toxicities from previous cancer therapies (excluding alopecia) must have recovered to grade 1 (defined by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.0). Chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis
  • ECOG performance status of 0 to 2

You may not qualify if:

  • Prior exposure to cumulative doses of doxorubicin \>400 mg/m2 or epirubicin \>720 mg/m2
  • Hypersensitivity to PLD or to any of the excipients
  • Unable to undergo imaging by either CT scan or MRI
  • Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications
  • Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ)
  • Is taking concurrent (or within 4 weeks prior to registration) chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). Supportive care measures are allowed. Palliative limited radiation therapy for pain reduction is allowed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Medische oncologie, Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Leuven University Hospitals

Leuven, B-3000, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, B-4000, Belgium

Location

Institut Català d'Oncologia, Hospital Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Cambridge Cancer Trials Centre, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Edinburgh Cancer Research Centre, The University of Edinburgh

Edinburgh, EH4 2XR, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, SM2 5PT, United Kingdom

Location

Imperial College London, Hammersmith Hospital Campus

London, W12 0NN, United Kingdom

Location

Related Publications (2)

  • Lehmann S, Bykov VJ, Ali D, Andren O, Cherif H, Tidefelt U, Uggla B, Yachnin J, Juliusson G, Moshfegh A, Paul C, Wiman KG, Andersson PO. Targeting p53 in vivo: a first-in-human study with p53-targeting compound APR-246 in refractory hematologic malignancies and prostate cancer. J Clin Oncol. 2012 Oct 10;30(29):3633-9. doi: 10.1200/JCO.2011.40.7783. Epub 2012 Sep 10.

    PMID: 22965953BACKGROUND

  • Deneberg S, Cherif H, Lazarevic V, Andersson PO, von Euler M, Juliusson G, Lehmann S. An open-label phase I dose-finding study of APR-246 in hematological malignancies. Blood Cancer J. 2016 Jul 15;6(7):e447. doi: 10.1038/bcj.2016.60. No abstract available.

    PMID: 27421096BACKGROUND

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsRecurrence

Interventions

eprenetapopt

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Senior Medical Advisor
Organization
Aprea Therapeutics
info@aprea.com
215-948-4119

Study Officials

  • Charlie Gourley, BSc, MB ChB, PhD, FRCP

    Edinburgh Cancer Research Centre, The University of Edinburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 31, 2017

Study Start

July 31, 2017

Primary Completion

July 10, 2019

Study Completion

July 10, 2019

Last Updated

March 17, 2025

Results First Posted

July 21, 2022

Record last verified: 2025-03

Locations

BE(3)ES(5)GB(4)