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Platinum-resistant Ovarian CancerPhase 2NCT05736952

Oral Topotecan Combined With Anlotinib in Patients With Platinum-resistant Recurrent Ovarian Cancer

A Phase 2 study testing Oral Topotecan Combined With Anlotinib in people with Platinum-resistant Ovarian Cancer, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the treatment of topotecan hydrochloride capsules combined with anlotinib hydrochloride capsules in Patients with platinum-resistant recurrent epithelial ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Platinum-resistant Ovarian Cancer
What is being tested?
Oral Topotecan Combined With Anlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
1 Mar 2023to 1 Feb 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age≥ 18 years old;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
  • The pathological type is epithelial ovarian cancer: high-grade serous, clear cell, endometrium-like; or fallopian tube cancer, primary peritoneal cancer;
  • After surgery, the patient received ≥ 2 lines of chemotherapy,Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy);
  • Clinical recurrence with measurable lesions (with imaging evidence);
  • Estimated survival≥ 3 months;
  • The main organs function well, and the examination indicators meet the following requirements: 1) Routine blood test: hemoglobin ≥ 90 g/L (no transfusion within 14 days); Neutrophil count≥ 1.5×109/L; Platelet count≥ 80×109/L; 2) Biochemical examination: Total bilirubin ≤1.5×ULN (upper limit of normal); Blood valley alanine aminotransferase (ALT) or blood valley aminotransferase (AST) ≤ 2.5×ULN; ALT or AST ≤ 5×ULN if liver metastases are present; Serum creatinine ≤ 1.5×ULN or endogenous creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula);
  • Good compliance, family members agree to cooperate with survival follow-up.

Who cannot join

  • Have other malignant tumors at the same time, except for malignant tumors that have been cured or stabilized;
  • Pregnant or lactating women;
  • Participated in clinical trials of other drugs within six months;
  • Have a variety of factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.);
  • Any bleeding event with a severe grade of 3 or above in CTCAE 4.0 within 4 weeks prior to screening;
  • Patients with known central nervous system metastases or history of central nervous system metastases before screening;
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  • Patients with hypertension who cannot be well controlled by single antihypertensive drugs (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); Patients with a history of unstable angina; Patients with a new diagnosis of angina within 3 months before screening or a myocardial infarction event within 6 months before screening; Arrhythmias require long-term use of antiarrhythmic drugs and New York Heart Association grade ≥ II cardiac insufficiency;
  • Long-term unhealed wounds or incompletely healed fractures;
  • Previous organ transplantation history;
  • Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the patient's tumor has a high possibility of invading important blood vessels during treatment and causing fatal hemorrhage;
  • Coagulation dysfunction (prothrombin time>16s, Activated partial thromboplastin>43s, thrombin time>21s, fibrinogen<2g/L), with bleeding tendency (14 days before randomization must meet: INR within normal value without anticoagulant); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; Under the premise of the international normalized ratio (INR) of prothrombin time (INR) ≤ 1.5, the use of low-dose warfarin (1 mg orally once daily) or low-dose aspirin (not exceeding 100 mg daily) for prophylactic purposes is permitted;
  • Screen for arteriovenous thrombotic events within one year before, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (except for venous thrombosis caused by venous catheterization with chemotherapy in the early stage of chemotherapy and judged to have been cured by the investigator) and pulmonary embolism;
  • Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders;
  • Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
  • According to the judgment of the investigator, there are serious concomitant diseases that endanger the safety of patients or affect the completion of the study;
  • History of surgical procedures within 28 days;
  • History of abdominal fistula or gastrointestinal perforation within 28 days;
  • Those who may receive other systemic anti-tumor therapy or plan to undergo ovarian cancer debulking surgery during the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai

Other trials in China

About this study

Official title: Oral Topotecan Combined With Anlotinib in Patients With Platinum-resistant Recurrent Ovarian Cancer：

The goal of this clinical trial is to evaluate the treatment of topotecan hydrochloride capsules combined with anlotinib hydrochloride capsules in Patients with platinum-resistant recurrent epithelial ovarian cancer. The main questions it aims to answer are: to assess the objective response rate (ORR), progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), overall survival (OS) and safety of topotecan hydrochloride capsules combined with anlotinib hydrochloride capsules in patients with platinum-resistant recurrent epithelial ovarian cancer.The treatment of participants： Topotecan hydrochloride capsules: 2 mg, once daily, oral with dinner for 5 days, discontinued for 16 days, that is, 21 days (3 weeks) as a course of treatment, a total of 6 courses of administration.；Anlotinib hydrochloride capsules: 10mg once a day, oral before breakfast, continuous administration for 14 days, discontinuation for 7 days, that is, 21 days (3 weeks) as a course of treatment. Receiving optimal supportive care at the same time until disease progression/death/intolerable toxicity.

Being tested
Oral Topotecan Combined With Anlotinib

What participants receive

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

  • Oral Topotecan Combined With AnlotinibDrug

    Topotecan hydrochloride capsules: 2 mg, once daily, oral with dinner for 5 days, discontinued for 16 days, that is, 21 days (3 weeks) as a course of treatment, a total of 6 courses of administration.；Anlotinib hydrochloride capsules: 10mg once a day, oral before breakfast, continuous administration for 14 days, discontinuation for 7 days, that is, 21 days (3 weeks) as a course of treatment.

Study groups in NCT05736952
Study groupRoleWhat they receive
Oral Topotecan Combined With AnlotinibExperimentalNot described
Receives: Drug: Oral Topotecan Combined With Anlotinib

What is being measured

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

  1. Objective response rate (ORR)

    Measured: one year

Secondary outcomes (4)

  1. progression-free survival (PFS)

    Measured: one year

  2. disease control rate (DCR)

    Measured: one year

  3. duration of response (DOR)

    Measured: one year

  4. overall survival (OS)

    Measured: one year

Timeline

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

  1. First posted21 Feb 2023
  2. Study start1 Mar 2023 (estimated)
  3. Primary completion1 Feb 2026 (estimated)
  4. Study completion1 Feb 2026 (estimated)

Why it stopped: Program changed

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05736952
Sponsor's protocol ID
XH-22-015
Status last verified
Feb 2023
First submitted
12 Feb 2023
Last updated
11 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oral Topotecan Combined With Anlotinib in people with Platinum-resistant Ovarian Cancer, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 8 inclusion and 18 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: withdrawn, as of the sponsor's last update on 11 May 2023. 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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: one year). 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 NCT05736952.

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 11 May 2023.

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