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Platinum Resistant Ovarian CancerPhase 2NCT06973421

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

A Phase 2 study testing Utidelone Capsules and Fruquintinib Capsules in people with Platinum Resistant Ovarian Cancer, run by Fudan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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 . Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Platinum Resistant Ovarian Cancer
What is being tested?
Utidelone Capsules and Fruquintinib Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
1 Jul 2025to 30 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • There was a history of arterial thrombosis or deep venous thrombosis within 6 months before the first use of the study drug; Thrombosis caused by implantable venous infusion pump or catheter, or superficial venous thrombosis, except those with stable thrombosis after regular anticoagulation therapy.
  • Patients with coagulation disorders, bleeding tendency, or undergoing anticoagulation therapy 2 months before the first use of the study drug.
  • Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
  • Acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months before the first use of the study drug; The New York Heart Association (NYHA) classification of congestive heart failure was ≥ 2; LVEF<50%； Or there is a history of myocarditis (including patients who have been cured after treatment of previous myocarditis) or other grade 3 or above cardiovascular events; Stroke events and/or transient cerebral ischemia occurred within 12 months before the first use of the study drug; Patients with uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg) were given standard treatment; Other researchers judged that there was a high risk of heart disease.
  • Uncontrolled diabetic patients within 3 months before the first use of the study drug.
  • Patients with active hepatitis B and/or C, i.e. HBsAg positive and/or HBcAb positive, detected HBV DNA positive and/or anti HCV positive and HCV RNA positive at the same time; Human immunodeficiency virus (HIV) antibody was positive; Treponema pallidum specific antibody was positive.
  • active infection or fever of unknown origin (body temperature>38.5 ℃) before screening and first use of the study drug.
  • patients with active autoimmune diseases need systemic treatment (i.e. disease regulators, corticosteroids or immunosuppressive drugs) within 2 years before enrollment. Replacement therapy (such as thyroxine, insulin or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered as a systemic treatment.
  • women who are pregnant or nursing or plan to be pregnant during the study period.
  • patients with mental disorders or poor compliance.
  • known allergic to the study drug or any of its excipients.
  • participate in another intervention clinical trial or use other research treatment at the same time.
  • the researcher believes that the subject has a serious history of systemic diseases or other reasons and is not suitable to participate in the trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hao Wen, MD contact

021-64175590

wenhao@shca.org.cn

China1 site

  • Fudan University Shanghai Cancer Cente

    Shanghai, Shanghai Municipality, 200032

    Hao Wen, MD, 021-64175590, wenhao@shca.org.cn

Other trials in China

About this study

Official title: Preliminary Phase II Clinical Study on the Efficacy and Safety of the Combination of Utidelone Capsules and Fruquintinib Capsules in the Treatment of Platinum Resistant Recurrent Ovarian Cancer

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.

Being tested
Utidelone Capsules, Fruquintinib Capsules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Utidelone CapsulesDrug

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

  • Fruquintinib CapsulesDrug

    5 mg orally, days 1 to 14, per cycle

Study groups in NCT06973421
Study groupRoleWhat they receive
Utidelone+FruquintinibExperimentalParticipants will receive Utidelone Capsules and Fruquintinib Capsules in combination. 21 days as a cycle.
Receives: Drug: Utidelone Capsules; Drug: Fruquintinib Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Objective response rate, according to RECIST v1.1

    Measured: Up to 24 months

Secondary outcomes (4)

  1. CA-125 remission rate

    evaluated according to gcic CA-125 standard

    Measured: Up to 24 months

  2. PFS

    Progression-free survival, according to RECIST v1.1

    Measured: approximately 2 years

  3. OS

    Overall survival, according to RECIST v1.1

    Measured: Up to 2 years

  4. AEs

    Adverse Events, according to CTCAE V5.0 criteria, During the trial, the adverse event record form should be truthfully filled in, including the occurrence time, severity, correlation with study treatment, duration, measures taken and outcome of the adverse event.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2025
  2. Study start1 Jul 2025 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06973421
Sponsor's protocol ID
FRUTD-001
Status last verified
May 2025
First submitted
7 May 2025
Last updated
15 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data is available per require after approved by ethics broad

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Utidelone Capsules and Fruquintinib Capsules in people with Platinum Resistant Ovarian Cancer, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hao Wen, MD (021-64175590, wenhao@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06973421.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.

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