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RECRUITING Phase 1

Combination Therapy for Recurrent Ovarian Cancer

NCT05610735 · View on ClinicalTrials.gov ↗

Study Summary

The proposed study "combination therapy with liposomal doxorubicin and withaferin A (Ashwagandha, ASWD) in recurrent ovarian cancer" is focused to determine the feasibility and maximum tolerance dose of Ashwagandha with liposomal doxorubicin (DOXIL) in recurrent ovarian cancer patients. The study contains two parts. In part 1 (phase I), 18 patients with recurrent ovarian cancer eligible for DOXIL therapy will be recruited and three doses of Ashwagandha (2.0 g, 4.0 g and 8.0 g) in the form of tablets along with DOXIL will be evaluated for feasibility and tolerance of ASWD. In part 2 (phase II), 54 patients with recurrent ovarian cancer will be recruited and treated with DOXIL and Ashwagandha (dose determined from part 1) to evaluate the complete response (CR), partial response (PR), and stable disease (SD).

Conditions Studied

Interventions

  • DRUG DOXIL
  • DRUG Withaferin A
  • DRUG Ashwagandha
  • DRUG Combination of ASWD and DOXIL

Study Locations (1)

Kentucky

  • UofL Health Brown Cancer Center — Louisville

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2024-09-25
Est. Completion 2028-11-30
Phase Phase 1

Sponsor

Sham Sunder Kakar

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05610735

The ClinicalTrials.gov registry entry for NCT05610735 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sham Sunder Kakar, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Recurrent Ovarian Cancer appearing as the primary indexed condition, and to 4 interventions — of which DOXIL is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05610735 reports 1 study location spanning 1 distinct geographic area — top geographies include Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05610735 about?

NCT05610735 is a clinical study titled "Combination Therapy for Recurrent Ovarian Cancer". The proposed study "combination therapy with liposomal doxorubicin and withaferin A (Ashwagandha, ASWD) in recurrent ovarian cancer" is focused to determine the feasibility and maximum tolerance dose of Ashwagandha with liposomal doxorubicin (DOXIL) in recurrent ovarian cancer patients. The study co...

What is the current status of trial NCT05610735?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2024-09-25. Estimated completion is 2028-11-30.

What conditions does trial NCT05610735 study?

This clinical trial studies the following conditions: Recurrent Ovarian Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05610735?

The interventions under investigation include: DOXIL (DRUG), Withaferin A (DRUG), Ashwagandha (DRUG), Combination of ASWD and DOXIL (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05610735?

This trial is sponsored by Sham Sunder Kakar, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05610735 being conducted?

This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial