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

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
Allarity Therapeutics
Study ID
NCT03878849
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Apr 15, 2019
Status verified
Aug 2025
Primary completion
Mar 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Drug: 2X-121 600 mg
    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.
  • Experimental: Drug: 2X-121 800 mg
    2X-121 will be administered 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.

Primary Outcome Measure

Evaluate the optimal dose of 2X-121 as single agent therapy [ Time Frame: From enrollment up to approximately 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
OU Health Stephenson CancerOklahoma CityOklahoma73104
Christine Pappaterra
[email protected]
405-271-8707
Kathleen Moore, MD (PRINCIPAL_INVESTIGATOR)
Swedish Center for Research and InnovationSeattleWashington98122
Karina Sills
[email protected]
1.206.386.2227
Fernanda Baptista Musa, MD (PRINCIPAL_INVESTIGATOR)

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