NCT05610735

Combination Therapy for Recurrent Ovarian Cancer

Recruiting now Phase 1, PHASE2 Last updated 19 March 2026

What this trial tests

Phase 1, PHASE2 trial testing DOXIL in Recurrent Ovarian Cancer in 72 participants. Currently enrolling.

Timeline

25 September 2024

Primary endpoint
30 November 2027

30 November 2028

Quick facts

Lead sponsor	Sham Sunder Kakar
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	25 September 2024
Primary completion	30 November 2027
Estimated completion	30 November 2028
Sites	1 location across United States

Drugs / interventions tested

• DOXIL (doxil) — full drug profile →
• Withaferin A — full drug profile →
• Ashwagandha — full drug profile →
• Combination of ASWD and DOXIL — full drug profile →

Conditions studied

• Recurrent Ovarian Cancer — all drugs for Recurrent Ovarian Cancer →

Sponsor

Sham Sunder Kakar — full company profile →

Who can join

18 and older, female only, with Recurrent Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ferroptosis in cancer: From molecular mechanisms to therapeutic strategies.
   Zhou Q, Meng Y, Li D, Yao L, et al · · 2024 · cited 439× · PMID 38453898 · DOI 10.1038/s41392-024-01769-5
2. Targeting ferroptosis opens new avenues for the development of novel therapeutics.
   Sun S, Shen J, Jiang J, Wang F, et al · · 2023 · cited 380× · PMID 37735472 · DOI 10.1038/s41392-023-01606-1
3. Oxidative cell death in cancer: mechanisms and therapeutic opportunities.
   An X, Yu W, Liu J, Tang D, et al · · 2024 · cited 258× · PMID 39090114 · DOI 10.1038/s41419-024-06939-5
4. Heat shock protein 90: biological functions, diseases, and therapeutic targets.
   Wei H, Zhang Y, Jia Y, Chen X, et al · · 2024 · cited 54× · PMID 38283176 · DOI 10.1002/mco2.470
5. Withaferin A: A Pleiotropic Anticancer Agent from the Indian Medicinal Plant <i>Withania somnifera</i> (L.) Dunal.
   Kumar S, Mathew SO, Aharwal RP, Tulli HS, et al · · 2023 · cited 42× · PMID 37259311 · DOI 10.3390/ph16020160
6. Ferroptosis as a new tool for tumor suppression through lipid peroxidation.
   Yang X, Liu Y, Wang Z, Jin Y, et al · · 2024 · cited 41× · PMID 39521912 · DOI 10.1038/s42003-024-07180-8
7. Interplay of Ferroptosis and Cuproptosis in Cancer: Dissecting Metal-Driven Mechanisms for Therapeutic Potentials.
   Wang J, Li J, Liu J, Chan KY, et al · · 2024 · cited 33× · PMID 38339263 · DOI 10.3390/cancers16030512
8. Ferroptosis: mechanisms and therapeutic targets.
   Zhou Q, Meng Y, Le J, Sun Y, et al · · 2024 · cited 32× · PMID 39568772 · DOI 10.1002/mco2.70010