๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-08-22

Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer (NCT03878849)

Phase 2, Randomized, Prospective, Open-Label, Parallel-Arm, Dose Optimization Study to Investigate the Safety, Tolerability, PK/PD, and Anti- Tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer.

๐ŸŸข Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Allarity Therapeutics

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: OU Health Stephenson Cancer โ€” Oklahoma City, Oklahoma

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (2 Sites)

  • OU Health Stephenson Cancer โ€” Oklahoma City, Oklahoma
  • Swedish Center for Research and Innovation โ€” Seattle, Washington

๐Ÿ“ž Contact the Study Coordinator

Phone: +1-301-528-7000 ext. 716

Email: kushd@amarexcro.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—