Ovarian CancerNCT03877796
Clinical Pre-screening Protocol for Ovarian Cancer
An observational study of Ovarian Cancer, run by Allarity Therapeutics at 9 sites in 2 countries.
Trial summary
The patient's local archival tumor tissue (FFPE) from original tumor, or from the metastatic tissue, will be collected to potentially identify if they - at a later stage of their disease - will be likely to benefit from treatment with any of the investigational cancer drugs available to Allarity Therapeutics. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Drug Response Predictor® (DRP)
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 11 Apr 2019to Dec 2027
- Phase
- Observational
- 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
Study population: Patients will be identified at their already planned treatment and or at control visits at the oncology department
Who may be able to join
- Patients with histological confirmed epithelia ovarian cancer
- Patients must have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible.
- Patients have received no more than one prior line of therapy in the platinum resistant or platinum ineligible setting
- FFPE tumor tissue available
Who cannot join
- Patients who have platinum-refractory disease, defined as progression during the last platinum-based chemotherapy.
- Other malignancy with exception of any stage I and II cancer that is deemed cured by the Investigator
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Europe: Rebecca Kristeleit contact
9 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
University of New Mexico Comprehensive Cancer
Albuquerque, New Mexico, 87131
Natalie Everett, nseverett@salud.unm.edu
Amaranta Craig, MD
- Recruiting
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
Nilaab Meer, 494-778-1900, nilaab.meer@emory.edu
Jennifer Scalici, MD
- Recruiting
University Medical Center Cancer Center
Lubbock, Texas, 79415
Mariana Fiori, Mariana.Fiori@ttuhsc.edu
Mark Reedy, MD
- Recruiting
The Blavatnik Family-Chelsea Medical Center at Mount Sinai
New York, New York, 10011
Neha Kumarley, 212-824-7859, neha.kumarley@mssm.edu
Stephanie Blank, MD
- Recruiting
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Christine Pappaterra, RN, 405-271-8707, Christine-Pappaterra@ouhsc.edu
Jacqueline Bohn,, MD
- Recruiting
Swedish Center for Research and Innovation
Seattle, Washington, 98122
Karina Sills, 206-386-2227, karina.sills@swedish.org
Fernanda Baptista Musa, MD
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Merry Markham, MD
United Kingdom2 sites, 2 recruiting
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN
Lauren Mcnamara, lauren.mcnamara@ggc.scot.nhs.uk
Ros Glasspool, MD
- Recruiting
Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital
London
Rebecca Kristeleit, MD
Samantha Barrett
About this study
Official title: Development of Drug Response Predictor (DRP) to Test Sensitivity to Investigational Anti-Cancer Drugs in Patients With Advanced Ovarian Cancer
The patient's local archival tumor tissue (FFPE) from original tumor, or from the metastatic tissue, will be collected to potentially identify if they - at a later stage of their disease - will be likely to benefit from treatment with any of the investigational cancer drugs available to Allarity Therapeutics. Data from this study can further be used to explore in a retrospective fashion, sensitivity to other chemotherapeutic drugs previously used in the treatment of their ovarian cancer, to investigate whether or not the DRP® method can predict and confirm the obtained sensitivity to the prior given drugs as well as prospective analyses guiding the Investigators on future treatments.
- Conditions
- Ovarian Cancer
- Being tested
- Drug Response Predictor® (DRP)
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Response Predictor® (DRP)Device
A DRP is an assay that based on samples from a tumor can predict whether the tumor will respond to a specific drug or not.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian cancer patients | with formalin-fixed paraffin-embedded (FFPE) tumor tissue available Receives: Device: Drug Response Predictor® (DRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of ovarian cancer patients with high likelihood of being sensitive to investigational cancer drug
based on FFPE ovarian cancer tissue
Measured: up to 2 years
Secondary outcomes (1)
Retrospective analysis of whether or not the DRP method can predict and confirm the obtained sensitivity to the prior drugs used in the treatment of ovarian cancer
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start11 Apr 2019
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allarity Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877796
- Sponsor's protocol ID
- 2X-1000
- Status last verified
- Jul 2026
- First submitted
- 14 Mar 2019
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Drug Response Predictor (DRP) to Test Sensitivity to Investigational Anti-Cancer Drugs in Patients With Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03877796
- Acronym / sponsor ID
- 2X-1000
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Allarity TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The patient's local archival tumor tissue (FFPE) from original tumor, or from the metastatic tissue, will be collected to potentially identify if they - at a later stage of their disease - will be likely to benefit from treatment with any of the investigational cancer drugs available to Allarity Therapeutics. Data from this study can further be used to explore in a retrospective fashion, sensitivity to other chemotherapeutic drugs previously used in the treatment of their ovarian cancer, to investigate whether or not the DRP® method can predict and confirm the obtained sensitivity to the prior given drugs as well as prospective analyses guiding the Investigators on future treatments.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian cancer patients | – | Device: Drug Response Predictor® (DRP)with formalin-fixed paraffin-embedded (FFPE) tumor tissue available |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be identified at their already planned treatment and or at control visits at the oncology department
Key inclusion criteria (4 listed)
- Patients with histological confirmed epithelia ovarian cancer
- Patients must have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible.
- Patients have received no more than one prior line of therapy in the platinum resistant or platinum ineligible setting
- FFPE tumor tissue available
Key exclusion criteria (2 listed)
- Patients who have platinum-refractory disease, defined as progression during the last platinum-based chemotherapy.
- Other malignancy with exception of any stage I and II cancer that is deemed cured by the Investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug Response Predictor® (DRP)A DRP is an assay that based on samples from a tumor can predict whether the tumor will respond to a specific drug or not. | Device | Ovarian cancer patients |
Primary outcome
Identification of ovarian cancer patients with high likelihood of being sensitive to investigational cancer drug
Time frame: up to 2 years
based on FFPE ovarian cancer tissue
1 secondary outcome
Retrospective analysis of whether or not the DRP method can predict and confirm the obtained sensitivity to the prior drugs used in the treatment of ovarian cancer
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Europe: Rebecca Kristeleit contact
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Allarity Therapeutics at 9 sites in 2 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 2 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 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, United Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 US: Kathleen Moore (+1 405-271-8707, KathleenMoore@ouhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of ovarian cancer patients with high likelihood of being sensitive to investigational cancer drug (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2026.