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Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer

ConditionAdvanced Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAllarity Therapeutics

About this trial

The purpose of this study is to evaluate the optimal dose of 2X-121 as single agent therapy at 600 mg daily (split BID 200 mg morning + 400 mg evening) compared to 800 mg daily (split BID 400 mg morning + 400 mg evening) in recurrent, advanced ovarian cancer patients that have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible. The optimal dose will be selected based on an integrated analysis of PK/PD, safety, and efficacy data.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent form.

Age 18 years or older.

Histologically or cytologically documented epithelial ovarian, fallopian tube, or primary peritoneal tumors, with high-grade serous or endometrioid, or predominantly serous/endometrioid histology (independent of BRCA1 and HRD status).

Patients must have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible.

Disqualifiers

Patients who have platinum-refractory disease, defined as progression during the last platinum-based chemotherapy.

Concurrent chemotherapy, antibody therapies 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 any stage I and II cancer that is deemed cured by the Investigator.

Any active infection requiring parenteral or oral antibiotic treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 2X-121

    Drug

    2X-121 will be administered daily as 600 mg (200 mg 2X-121 morning dose + 400 mg (2 x 200 mg) 2X-121 evening dose) hard gelatin capsules in a 28 days cycle.

  • 2X-121

    Drug

    2X-121 will be administered daily as 800 mg (400 mg (2 x 200 mg) 2X-121 morning dose + 400 mg (2 x 200 mg) 2X-121 evening dose) hard gelatin capsules in a 28 days cycle.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Drug: 2X-121 600 mgExperimental treatment 1 intervention
Group B: Drug: 2X-121 800 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the optimal dose of 2X-121 as single agent therapy

To evaluate the optimal dose of 2X-121 as single agent therapy at 600 mg daily compared to 800 mg daily.

Time frame
From enrollment up to approximately 2 years

Secondary outcomes

1

Clinical benefit rate (CBR)

Time frame
From enrollment up to approximately 2 years
2

Progression free survival

Time frame
From enrollment up to approximately 2 years
3

Overall survival

Time frame
From enrollment up to approximately 2 years
4

Evaluate disease control rate (DCR)

Time frame
At baseline and start of each cycle, up to approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Allarity Therapeutics

Lead sponsor

Alcedis GmbH

Collaborator

Amarex Clinical Research

Collaborator

Source ClinicalTrials.gov
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