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NCT05610735 · ClinicalTrials.gov registry record · Phase 1
Combination Therapy for Recurrent Ovarian Cancer
A Phase 1 study of Recurrent Ovarian Cancer, sponsored by Sham Sunder Kakar.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT05610735: Recruiting Phase 1 study of Recurrent Ovarian Cancer, sponsored by Sham Sunder Kakar.
NCT05610735 is a Phase 1 study of Recurrent Ovarian Cancer that is actively recruiting participants, run by Sham Sunder Kakar. The registered enrollment target is 72 participants, below the 179-participant average among 6 other Recurrent Ovarian Cancer trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05610735, a Phase 1 study of Recurrent Ovarian Cancer, is actively recruiting participants, sponsored by Sham Sunder Kakar.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
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).
Primary Outcome
Will be presented by Kaplan Meier methods.
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
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2024-09-25 |
| Est. Completion | 2028-11-30 |
| Phase | Phase 1 |
What NCT05610735 shows while recruiting
NCT05610735 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 179-participant average among 6 other Recurrent Ovarian Cancer trials with a reported enrollment target (60% lower).
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.
NCT05610735 reports a single indexed study location in Kentucky.
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.
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).
Who is sponsoring clinical trial NCT05610735?
This trial is sponsored by Sham Sunder Kakar, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
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