Platinum-resistant Recurrent Ovarian CancerPhase 2NCT05325229
A Study of Docetaxel for Injection (Albumin-bound) in Combination With Bevacizumab in Patients With Ovarian Cancer
A Phase 2 study testing Docetaxel for injection (Albumin-bound) and Bevacizumab in people with Platinum-resistant Recurrent Ovarian Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This trial is a single-arm, multicenter clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) combined with Bevacizumab and the pharmacokinetic characteristics of Docetaxel in patients with platinum-resistant recurrent ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 78 years, women only
- Conditions the study is for
- Platinum-resistant Recurrent Ovarian Cancer
- What is being tested?
- Docetaxel for injection (Albumin-bound) and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2022to Dec 2024
- 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 to 78 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18, ≤78 years (subject to the date when the informed consent form is signed) and voluntarily signed the informed consent form.
- Histologically or cytologically confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Patients who responded to their last line of platinum treatment, and the disease recurred or progressed between 28 days to 6 months (184 calendar days) after the last platinum therapy (platinum-resistant disease), with no more than two lines of non-platinum therapy.
- At least one measurable lesion according to RECIST v1.1.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Patients with estimated survival time of ≥ 3 months.
Show all 10Show fewer
- Main organ function meets the following criteria within 7 days before treatment (no medical supportive treatments such as blood component transfusion, human granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), interleukin-11, and erythropoietin (EPO) within 2 weeks before administration of the investigational drug):
- Absolute neutrophil count ≥1.5×10^9/L; Platelets ≥100×10^9/L; Hemoglobin ≥90 g/L or ≥5.6 mmol/L; Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 40 mL/min; Liver function: total bilirubin≤ 1.0 × ULN, ≤ 1.5 × ULN for patients with liver metastasis; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN, ≤ 2.5 × ULN for patients with liver metastasis.
- Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN, International Normalized Ratio (INR) ≤ 1.5×ULN.
- The patient must agree to take adequate contraception from signing of ICF through 6 months after last dose, women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of the investigational drug.
Who cannot join
- Patients who have received anti-angiogenic therapy (including but not limited to bevacizumab, apatinib, anlotinib, etc.) within 18 weeks before the first use of the investigational drug.
- The progression-free interval of previous docetaxel treatment was less than 6 months.
- Patients whose disease progressed during platinum therapy (from the first dose to 28 days after the last dose).
- Mucinous ovarian cancer or less malignant ovarian tumors (such as low-grade serous ovarian cancer).
- Symptomatic central nervous system (CNS) metastases or cancerous meningitis (Patients may participate in this study if they have completed radiotherapy or surgery for CNS metastases prior to screening, and the patient's nervous system has been stable for ≥4 weeks after radiotherapy or post-surgery (i.e., no new neurological deficits due to brain metastases, no new lesions on CNS imaging, and no treatment is required at screening)).
- History of other malignant tumors within 5 years before the first dose of the investigational drug, except for the following: curable cancer such as basal cell or squamous cell skin cancer, superficial bladder cancer, prostate cancer, cervical cancer or breast cancer in situ that had been cured.
Show all 30Show fewer
- Patients with a history of thromboembolism, cerebral infarction, hemorrhagic disease or bleeding tendency within 6 months before the first dose of the investigational drug.
- History of intestinal obstruction, gastrointestinal perforation, abdominal fistula or abdominal abscess within 6 months before the first dose of the investigational drug.
- Abdominal or pelvic radiotherapy within 5 years before the first dose of the investigational drug.
- Urine protein >2+, or urine protein is 2+ with 24-hour urine protein quantitative >1g at screening.
- Patients who are known to be allergic to the investigational drug or its main excipients.
- Patients with an uncontrollable third space effusion (e.g. pleural effusion, ascites, or pericardial effusion), who, in the judgment of the investigator, are not suitable for the study.
- Patients with a history of severe cardiovascular disease, including but not limited to:
- Severe heart rhythm or conduction abnormalities, including but not limited to ventricular arrhythmia requiring clinical intervention and third degree atrioventricular block within 6 months before the first dose of the investigational drug;
- History of myocardial infarction, angina pectoris, angioplasty and coronary artery bypass surgery within 6 months before the first dose of the investigational drug;
- Heart failure with New York Heart Association (NYHA) Classification of Class III and above;
- Poorly controlled hypertension (Systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 95 mmHg at screening period despite optimal therapy);
- Patients with prolonged QT/QTc interval (QTcF > 480 ms, Fridericia's formula: QTcF = QT/RR^0.33, RR = 60/heart rate) during the screening period;
- Left ventricular ejection fraction (LVEF) <50% during the screening period.
- HCV antibody (+) is positive during the screening period (HCV RNA negative can be included, anti-HCV treatment other than interferon is allowed), active hepatitis B disease (HBV DNA ≤2000 IU/mL can be included, anti-HBV treatment other than interferon is allowed), HIV positive, or with acquired immunodeficiency syndrome (AIDS).
- Patients who have undergone major organ surgery within 4 weeks before the first dose of the investigational drug, or who need to undergo elective surgery during the study.
- Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0 (except for the toxicity without safety risk judged by the investigator, such as Grade 2 neuropathy, alopecia).
- Patients who have received anti-tumor treatments such as chemotherapy, targeted therapy, immunotherapy and other clinical study drugs within 4 weeks before the first dose of the investigational drug, and other conditions are as follows: Local palliative radiotherapy within 2 weeks before the first dose of the investigational drug; oral fluoropyrimidines, small molecule targeted drugs, etc. within 2 weeks before the first dose of the investigational drug or within known 5 half-lives of the drug (whichever is longer); Traditional Chinese medicines with anti-tumor indications within 2 weeks before the first dose of the investigational drug.
- Patients who have used potent inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of the investigational drug.
- Patients who have received a live attenuated vaccine within 4 weeks before the first use of the investigational drug.
- Patients who have taken aspirin (>325mg/day) or other non-steroidal anti-inflammatory drugs that may affect platelet function within 10 days before the first use of the investigational drug.
- Nursing women.
- Patients with active infection requiring intravenous antibiotic therapy (at the discretion of the investigator).
- Patients with a history of alcohol or drug dependence.
- Other situations that the investigator considers not suitable for participating in the clinical study, including but not limited to: the patient is complicated by severe or uncontrolled medical conditions, which interfere with the interpretation of study results and affect the study compliance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital,Tongji Medical College of HUST
Wuhan, Hubei
Ding Ma, +86-13886090620, dingma424@126.com
Qinglei Gao, +86-13871127473, 2482880446@qq.com
About this study
Official title: A Single-arm, Multicenter, Phase II Clinical Study of Docetaxel for Injection (Albumin-bound) in Combination With Bevacizumab in Patients With Platinum-Resistant Recurrent Ovarian Cancer
This trial is a single-arm, multicenter clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) combined with Bevacizumab and the pharmacokinetic characteristics of Docetaxel in patients with platinum-resistant recurrent ovarian cancer.
Read the detailed description
This study will be conducted in two stages (dose escalation trial and phase II trial). Dose escalation trial: To explore the safety and tolerability of Docetaxel for Injection (Albumin-bound) (75 mg/m^2 and 100 mg/m^2) combined with Bevacizumab 15 mg/kg. Dose escalation will be started at low dose and proceed in turn.
Phase II trial: According to the recommended phase II dose (RP2D) determined in the dose escalation trial, a phase II study of Docetaxel for Injection (Albumin-bound) combined with Bevacizumab will be conducted to observe the efficacy of the combination regimen, with overall response rate (ORR) as the primary study endpoint. Simon's optimal 2-stage design will be adopted for phase II study.
- Being tested
- Docetaxel for injection (Albumin-bound), Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel for injection (Albumin-bound)Drug
Docetaxel for injection (Albumin-bound), by intravenous infusion，75 mg/m^2 or 100 mg/m^2 once every 3 weeks.
BevacizumabDrug
Bevacizumab, by intravenous infusion, 15 mg/kg once every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel combined with Bevacizumab | Experimental | Docetaxel for Injection (Albumin-bound) will be administrated once every 3 weeks at a dose of 75 mg/m^2 or 100 mg/m^2; Bevacizumab will be administrated once every 3 weeks at a dose of 15mg/kg. Receives: Drug: Docetaxel for injection (Albumin-bound); Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation trial: Incidence of adverse event(AE)
Measured: Up to approximately 2 years
Phase II trial: Overall response rate (ORR) by Independent Review Committee(IRC)
Measured: Up to approximately 2 years
Dose escalation trial: Serious adverse event(SAE )
Measured: Up to approximately 2 years
Dose escalation trial: Dose limiting toxicity(DLT).
Measured: Up to approximately 2 years
Secondary outcomes (13)
Dose escalation trial and Phase II trial: Plasma concentration of docetaxel (free and total
Measured: Up to approximately 3 months
Phase II trial: ORR by investigator
Measured: Up to approximately 2 years
Phase II trial: Disease control rate (DCR)
Measured: Up to approximately 2 years
Phase II trial: Duration of Response (DOR)
Measured: Up to approximately 2 years
Phase II trial: Progression-Free-Survival (PFS)
Measured: Up to approximately 2 years
Phase II trial: Overall survival (OS)
Measured: Up to approximately 2 years
Phase II trial: CA125 response rate
Proportion of patients with a minimum 50% reduction in CA125 serum levels lasting for 28 days relative to baseline CA-125 serum levels, for patients whose baseline CA-125 serum levels ≥2×ULN.
Measured: Up to approximately 2 years
Phase II trial: Incidence of AE
Measured: Up to approximately 2 years
Phase II trial: abnormal vital signs
Measured: Up to approximately 2 years
Phase II trial: abnormal physical examination
Measured: Up to approximately 2 years
Phase II trial: abnormal electrocardiogram
Measured: Up to approximately 2 years
Phase II trial: abnormal laboratory tests
Measured: Up to approximately 2 years
Phase II trial: Eastern Cooperative Oncology Group（ECOG） scores
There are 6 values (0, 1,2,3,4,5) in the ECOG score system. A higher score means a worse outcome, for example, 0 means normal, 5 means death.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start18 Aug 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platinum-resistant Recurrent Ovarian CancerStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xuekun Yao, Study director, CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325229
- Sponsor's protocol ID
- HB1801-005
- Status last verified
- Mar 2022
- First submitted
- 24 Mar 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter, Phase II Clinical Study of Docetaxel for Injection (Albumin-bound) in Combination With Bevacizumab in Patients With Platinum-Resistant Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05325229
- Acronym / sponsor ID
- HB1801-005
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a single-arm, multicenter clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) combined with Bevacizumab and the pharmacokinetic characteristics of Docetaxel in patients with platinum-resistant recurrent ovarian cancer.
Detailed description
This study will be conducted in two stages (dose escalation trial and phase II trial). Dose escalation trial: To explore the safety and tolerability of Docetaxel for Injection (Albumin-bound) (75 mg/m^2 and 100 mg/m^2) combined with Bevacizumab 15 mg/kg. Dose escalation will be started at low dose and proceed in turn.
Phase II trial: According to the recommended phase II dose (RP2D) determined in the dose escalation trial, a phase II study of Docetaxel for Injection (Albumin-bound) combined with Bevacizumab will be conducted to observe the efficacy of the combination regimen, with overall response rate (ORR) as the primary study endpoint. Simon's optimal 2-stage design will be adopted for phase II study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel combined with Bevacizumab | Experimental | Drug: Docetaxel for injection (Albumin-bound), Drug: BevacizumabDocetaxel for Injection (Albumin-bound) will be administrated once every 3 weeks at a dose of 75 mg/m^2 or 100 mg/m^2; Bevacizumab will be administrated once every 3 weeks at a dose of 15mg/kg. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged ≥18, ≤78 years (subject to the date when the informed consent form is signed) and voluntarily signed the informed consent form.
- Histologically or cytologically confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Patients who responded to their last line of platinum treatment, and the disease recurred or progressed between 28 days to 6 months (184 calendar days) after the last platinum therapy (platinum-resistant disease), with no more than two lines of non-platinum therapy.
- At least one measurable lesion according to RECIST v1.1.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
Key exclusion criteria (30 listed)
- Patients who have received anti-angiogenic therapy (including but not limited to bevacizumab, apatinib, anlotinib, etc.) within 18 weeks before the first use of the investigational drug.
- The progression-free interval of previous docetaxel treatment was less than 6 months.
- Patients whose disease progressed during platinum therapy (from the first dose to 28 days after the last dose).
- Mucinous ovarian cancer or less malignant ovarian tumors (such as low-grade serous ovarian cancer).
- Symptomatic central nervous system (CNS) metastases or cancerous meningitis (Patients may participate in this study if they have completed radiotherapy or surgery for CNS metastases prior to screening, and the patient's nervous system has been stable for ≥4 weeks after radiotherapy or post-surgery (i.e., no new neurological deficits due to brain metastases, no new lesions on CNS imaging, and no treatment is required at screening)).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel for injection (Albumin-bound)Docetaxel for injection (Albumin-bound), by intravenous infusion，75 mg/m^2 or 100 mg/m^2 once every 3 weeks. | Drug | Docetaxel combined with Bevacizumab |
| BevacizumabBevacizumab, by intravenous infusion, 15 mg/kg once every 3 weeks. | Drug | Docetaxel combined with Bevacizumab |
Primary outcome
Dose escalation trial: Incidence of adverse event(AE)
Time frame: Up to approximately 2 years
Phase II trial: Overall response rate (ORR) by Independent Review Committee(IRC)
Time frame: Up to approximately 2 years
Dose escalation trial: Serious adverse event(SAE )
Time frame: Up to approximately 2 years
Dose escalation trial: Dose limiting toxicity(DLT).
Time frame: Up to approximately 2 years
13 secondary outcomes
Dose escalation trial and Phase II trial: Plasma concentration of docetaxel (free and total
Time frame: Up to approximately 3 months
Phase II trial: ORR by investigator
Time frame: Up to approximately 2 years
Phase II trial: Disease control rate (DCR)
Time frame: Up to approximately 2 years
Phase II trial: Duration of Response (DOR)
Time frame: Up to approximately 2 years
Phase II trial: Progression-Free-Survival (PFS)
Time frame: Up to approximately 2 years
Phase II trial: Overall survival (OS)
Time frame: Up to approximately 2 years
Phase II trial: CA125 response rate
Time frame: Up to approximately 2 years
Phase II trial: Incidence of AE
Time frame: Up to approximately 2 years
Phase II trial: abnormal vital signs
Time frame: Up to approximately 2 years
Phase II trial: abnormal physical examination
Time frame: Up to approximately 2 years
Phase II trial: abnormal electrocardiogram
Time frame: Up to approximately 2 years
Phase II trial: abnormal laboratory tests
Time frame: Up to approximately 2 years
Phase II trial: Eastern Cooperative Oncology Group（ECOG） scores
Time frame: Up to approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Platinum-resistant Recurrent Ovarian Cancer
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 1
Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
Recurrent Ovarian High Grade Serous Adenocarcinoma, Recurrent Platinum-Resistant Ovarian Carcinoma
Active, not recruitingPhase 2
P53MVA and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Recurrent Platinum-Resistant Fallopian Tube Carcinoma, Recurrent Platinum-Resistant Ovarian Carcinoma
RecruitingPhase 1
Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer
Recurrent Endometrial Carcinoma, Recurrent Endometrial Clear Cell Adenocarcinoma
RecruitingPhase 1
A Phase 1 Study to Evaluate OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
Endometrial Cancer Recurrent, Endometrial Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuekun Yao study director
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel for injection (Albumin-bound) and Bevacizumab in people with Platinum-resistant Recurrent Ovarian Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. 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 10 inclusion and 30 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: status not confirmed, as of the sponsor's last update on 13 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhe Zhang (1315039707, zhangzhe@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose escalation trial: Incidence of adverse event(AE) (time frame: Up to approximately 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2022.