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Metastatic Breast CancerPhase 2NCT03562832

Investigation of Anti-tumour Effect and Tolerability of the PARP Inhibitor 2X-121 in Patients With Metastatic Breast Cancer Selected by the 2X-121 DRP

A Phase 2 study testing PARP inhibitor 2X-121 in people with Metastatic Breast Cancer, run by Allarity Therapeutics at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

2X-121 is a small molecule targeted inhibitor of Poly ADP ribose polymerase (PARP), a key enzyme involved in DNA damage repair in cancer cells. The PARP inhibitor demonstrated clinical activity in a prior Phase 1 study in a number of solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
PARP inhibitor 2X-121
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesDenmark
Study dates
20 Jun 2018to 1 Aug 2024
Phase
Phase 2
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent form.
  • Age 18 years or older.
  • Histologically or cytological documented mBC (independent of hormone receptor, HER2 status and BRCA1 or 2 status) relapsed in 2 or more different prior therapies.
  • Measurable disease by CT scan or MRI.
  • With a drug response prediction (DRP) for 2X-121 with an outcome measured as being in the upper 20% likelihood of response.
  • Prior chemotherapy or hormone therapy for metastatic breast cancer is allowed.
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  • Performance status of ECOG <= 1
  • Recovered to Grade 1 or less from prior surgery or from acute toxicities of prior radiotherapy, or from treatment with cytotoxic, hormonal or biologic agents).
  • >= 2 weeks must have elapsed since any prior surgery or therapy with G-CSF and GM-CSF.
  • Patients with intracranial disease must be on stable or decreased level of steroid therapy (e.g. dexamethasone) for at least 7 days prior to baseline MRI. Non-enzymatic inducing ant-epileptic drugs are allowed.
  • Adequate conditions as evidenced by the following clinical laboratory values:
  • Absolute neutrophils count (ANC) >= 1.5 x 10E9/L
  • Haemoglobin is at least 4.6 mmol/L
  • Platelets >= 100 x 10E9 /L
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 x ULN*
  • Serum bilirubin <= 1.5 ULN
  • Alkaline phosphatase <= 2.5 x ULN*
  • Creatinine <= 1.5 ULN
  • Blood urea within normal limits
  • Creatinine clearance within normal limits. *In case of known liver metastases with ALT and AST <= 5 x ULN and/or alkaline phosphatase <= 5 x ULN. Patients who do not conform to the transaminase and/or alkaline phosphatase inclusion criteria, but who by the PI are considered in good PS and otherwise eligible for inclusion, and where the transaminase and/or alkaline phosphatase levels are considered elevated due to other reasons than deteriorated lever capacity, may be considered for inclusion based on conferred agreement between PI and sponsor.
  • Life expectancy equal or longer than 3 months.
  • Sexually active females of child-producing potential must use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception) for the study duration and at least six months afterwards.

Who cannot join

  • - Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period.
  • Other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study.
  • Previous treatment with PARP inhibitors
  • Any active infection requiring parenteral or oral antibiotic treatment.
  • Has known HIV positivity.
  • Has known active hepatitis B or C.
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  • Has clinical significant (i.e. active) cardiovascular disease:
  • Stroke within <= 6 months prior to day 1
  • Transient ischemic attach (TIA) within <= 6 months prior to day 1
  • Myocardial infarction within <= 6 months prior to day 1
  • Unstable angina
  • New York Hart Association (NYHA) Grade II or greater congestive heart failure (CHF)
  • Serious cardiac arrhythmia requiring medication
  • Mental status is not fit for clinical study or CNS disease including symptomatic epilepsy.
  • Other medications or conditions, including surgery, that in the Investigator's opinion would contraindicate study participation of safety reasons or interfere with the interpretation of study results
  • Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of 2X-121.
  • Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy.
  • Female patients who are pregnant or breast-feeding (pregnancy test with a positive result before study entry)

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Herlev and Gentofte Hospital, Herlev Ringvej 75, DK-2730 Herlev

    Herlev, 2730

  • Vejle Sygehus

    Vejle, 7100

Other trials in Denmark

About this study

Official title: Phase II, Open Label Clinical Study to Investigate Anti-tumour Effect and Tolerability of the PARP Inhibitor 2X-121 in Patients With Metastatic Breast Cancer Selected by the 2X-121 DRP

2X-121 is a small molecule targeted inhibitor of Poly ADP ribose polymerase (PARP), a key enzyme involved in DNA damage repair in cancer cells. The PARP inhibitor demonstrated clinical activity in a prior Phase 1 study in a number of solid tumors. 2X-121 has a novel dual-inhibitory action against both PARP 1/2 and Tankyrase 1/2. The molecule is also active in P-glycoprotein expressing cells, suggesting it may overcome some of the PARP inhibitor resistance.

The Phase 2 study is using 2x-121 DRP® biomarker in metastatic breast cancer patients to identify patients likely to respond to and benefit from treatment with 2X-121.

Being tested
PARP inhibitor 2X-121
Keywords
PARP inhibitor, Drug Response Prediction (DRP), Tankyrase 1/2 inhibitor, mRNA biomarker
Medical subject headings
Breast Neoplasms

What participants receive

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

  • PARP inhibitor 2X-121Drug

    600 mg PARP inhibitor 2X-121 as single daily oral agent in mBC patients

Study groups in NCT03562832
Study groupRoleWhat they receive
PARP inhibitor 2X-121Experimental600 mg PARP inhibitor 2X-121 as single daily oral agent in mBC patients
Receives: Drug: PARP inhibitor 2X-121

What is being measured

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

  1. Anti-tumour efficacy after treatment with 600 mg 2X-121 as single oral agent in a 21-days cycle in mBC patients selected by the 2X-121 DRP

    Overall tumor response according to RECIST

    Measured: one year

Secondary outcomes (5)

  1. Progression free survival (PFS) after administration of 2X-121 in patients with mBC

    Timespan

    Measured: one year

  2. Duration of objective response after administration of 2X-121 in patients with mBC

    Timespan

    Measured: one year

  3. Overall survival (OS) after administration of 2X-121 in patients with mBC

    Timespan

    Measured: one year

  4. Performance status (ECOG)

    To evaluate change in patient performance status by ECOG (Eastern Cooperative Oncology Group) Performance Status by a 6-step classification system

    Measured: one year

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Adverse Events as assessed by CTCAE v4. to evaluate safety profile after administration of 2X-121 in patients with mBC

    Measured: one year

Timeline

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

  1. First posted20 Jun 2018
  2. Study start20 Jun 2018
  3. Primary completion1 Apr 2024
  4. Study completion1 Aug 2024

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03562832
Sponsor's protocol ID
OV-121
Other IDs
SMR-3475
Status last verified
Jan 2025
First submitted
26 Apr 2018
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PARP inhibitor 2X-121 in people with Metastatic Breast Cancer, run by Allarity Therapeutics at 2 sites in Denmark.

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 22 inclusion and 18 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: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. 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.

What does this 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-tumour efficacy after treatment with 600 mg 2X-121 as single oral agent in a 21-days cycle in mBC patients selected by the 2X-121 DRP (time frame: one year). 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 NCT03562832.

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 23 Jan 2025.

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