Phase II Study of Utidelone Plus Fruquintinib Combination Therapy for Platinum-Resistant Recurrent Ovarian Cancer

NCT06973421 | Not Yet Recruiting Phase 2

• 1 other identifier: FRUTD-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Prospective, Single-arm, Phase 2 clinical trial. The purpose of this study is to find out if taking Utidelone Capsules together with Fruquintinib Capsules is safe and works well for people with platinum-resistant ovarian cancer . Researchers will look at the Objective Response Rate, Progression-Free Survival, Overall Survival, safety, and any side effects.

Conditions

Platinum Resistant Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate, according to RECIST v1.1

  Up to 24 months

Secondary Outcomes (4)

• CA-125 remission rate

  Up to 24 months

• PFS

  approximately 2 years

• OS

  Up to 2 years

• AEs

  From the first drug administration to within 30 days for the last treatment dose

Study Arms (1)

Utidelone+Fruquintinib

EXPERIMENTAL

Participants will receive Utidelone Capsules and Fruquintinib Capsules in combination. 21 days as a cycle.

Drug: Utidelone Capsules; Drug: Fruquintinib Capsules

Interventions

Utidelone Capsules DRUG

60 mg/m2 orally, days 1 to 5, per cycle

Utidelone+Fruquintinib

Fruquintinib Capsules DRUG

5 mg orally, days 1 to 14, per cycle

Utidelone+Fruquintinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects were fully informed, voluntarily signed the informed consent, and were willing and able to follow the planned visit, research treatment plan, laboratory examination and other research procedures.
• Female subjects aged ≥ 18 and ≤ 70 at the time of signing the informed consent.
• Malignant epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer were confirmed by histology or pathology.
• Subjects had at least one measurable lesion defined by RECIST v1.1.
• The number of lines of previous systematic anti-tumor treatment ≤ 3 (neoadjuvant and adjuvant chemotherapy are not considered as previous systematic treatment, unless disease progression occurs during its chemotherapy or within 6 months after the last chemotherapy).
• ECoG physical status score was 0 or 1.
• The baseline examination confirmed that there was sufficient bone marrow and organ function, and no relevant supportive treatment, such as gcs-f, EPO or blood transfusion, was used within 14 days before the laboratory examination in the screening period. (see the table on the next page for specific indicators)
• The expected survival time was more than 12 weeks.
• Fertile patients must agree to use reliable contraceptive methods (hormone or barrier method or abstinence) with their partners during the trial and at least 3 months after the last medication; The blood or urine pregnancy test of female patients of childbearing age must be negative before enrollment.

You may not qualify if:

• It has clear cell, mucinous or sarcomatous histology, contains mixed tumors of any histological type, or low-grade/borderline ovarian cancer.
• In platinum refractory ovarian cancer subjects, platinum refractory was defined as the best response during the first platinum containing regimen treatment as disease progression or recurrence, or disease recurrence or progress within 4 weeks after the end of platinum containing regimen treatment.
• Other malignant tumors within 5 years, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and papillary carcinoma of the thyroid.
• Received nitrosourea or mitomycin C within 6 weeks before the first use of the study drug; received anti-tumor treatment within 4 weeks or 5 half lives (whichever is shorter) before the first use of the study drug, including chemotherapy, radiotherapy, biological targeted therapy, immunotherapy, etc; Oral fluorouracil, small molecule targeted drugs and endocrine therapy were used 2 weeks before the first use of the study drug or within 5 half lives of the drug (whichever is shorter); Traditional Chinese medicine or Chinese patent medicine with anti-tumor indications were used within 2 weeks before the first use of the study drug.
• Major surgical operations (craniotomy, thoracotomy or laparotomy or other operations defined by the investigator) or significant trauma were performed within 60 days before the first use of the study drug, or elective surgery was required during the trial.
• There were patients with clinically significant skin wounds, surgical sites, wound sites, severe mucosal ulcers or fractures that were not completely healed as assessed by the researchers.
• Patients with peripheral neuropathy with CTCAE 5.0 rating ≥ 2.
• The adverse reactions of previous anti-tumor treatment have not recovered to CTCAE 5.0 grade evaluation ≤ 1 (except for the toxicity without safety risk judged by researchers such as hair loss).
• Patients who have previously received eutidylon or antiangiogenic drugs (except bevacizumab).
• Urine protein detection 2+or more, or 24-hour urine protein quantitation ≥ 1.0g/24h.
• There were symptoms or thyroid dysfunction requiring treatment at the time of screening.
• Patients with obvious evidence of bleeding tendency or medical history within 2 months before the first use of the study drug, such as black stool, hematemesis, hemoptysis, occult blood in stool++, etc.
• Subjects with active central nervous system metastasis.
• Cancerous ascites with clinical symptoms requiring puncture and drainage; Or those who received drainage for the purpose of treatment within 30 days before the first use of the study drug.
• During screening, it was found that the tumor invaded the structure of large blood vessels, such as pulmonary artery, superior vena cava or inferior vena cava, and the researchers judged that there was a high risk of bleeding; Or there is a history of previously known aneurysms.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Cente

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

HMPL-013

Central Study Contacts

Hao Wen, MD

CONTACT

021-64175590; wenhao@shca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Gynecologic Oncology

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

CN (1)