AzTrials
AzTrials

Platinum-resistant Recurrent Ovarian CancerPhase 2APPROVENCT04348032

Apatinib Combined With PLD vs PLD for Platinum-resistant Recurrent Ovarian Cancer

A Phase 2 study testing PLD 40mg/m2 ivgtt q4w +Apatinib 250mg po qd and PLD 40mg/m2 ivgtt q4w in people with Platinum-resistant Recurrent Ovarian Cancer, run by Chinese Academy of Medical Sciences at 16 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Epithelial ovarian cancer is the most fatal gynecological malignancy. Despite initial therapeutic response, the majority of advanced-stage patients relapse and eventually succumb to chemoresistant disease. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
PLD 40mg/m2 ivgtt q4w +Apatinib 250mg po qd and PLD 40mg/m2 ivgtt q4w
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
16 sitesChina
Study dates
22 Mar 2018to 30 Jun 2022
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

  • Patients were diagnosed with ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by previous pathology, and the pathological type was non-mucinous adenocarcinoma.There were previous surgical wax preservation.
  • Initial platinum-resistant relapse, the recurrence time was less than 6 months after the last chemotherapy.
  • Complicated with malignant pleural effusion or ascites, or with recurrent lesions that can be evaluated clinically.
  • ECOG physical status score 0 or 1.
  • The expected survival time is ≥ 4 months.
  • In the previous treatment, there was no antivascular targeted therapy;
Show all 15Show fewer
  • Patients without pleural effusion or ascites should be confirmed by CT or MRI according to the standard of RECIST1.1 version, requiring the patient to have at least one measurable focus as the target focus. If the target focus is a lymph node with a short diameter of more than 1.5 cm, and the target focus is not suitable for surgical treatment, the target focus has not received radiotherapy or relapsed in the radiotherapy field.
  • The baseline blood routine conforms to the following criteria:
  • neutrophil count ≥ 1.5x109 /L;
  • platelet count ≥ 100x109 PG L;
  • hemoglobin ≥ 9g/dL (blood transfusion is allowed to achieve or maintain this target) .
  • Liver function meets the following criteria:
  • total bilirubin<1.5 normal limit (ULN);
  • glutamic oxaloacetic transaminase (AST), glutamic pyruvic transaminase (ALT)<2.5xULN, which is allowed<5xULN in patients with liver metastasis.
  • Serum creatinine ≤ 1.25xULN or calculated creatinine clearance ≥ 50mL/min.

Who cannot join

  • Have received more than two chemotherapy regimens in the past.
  • Currently or recently (within 30 days before enrollment) using another research drug or participating in another clinical study.
  • other malignant tumors have occurred within 5 years (except adequately treated cervical carcinoma in situ or skin squamous cell carcinoma, or controlled basal cell carcinoma of the skin).
  • Patients with hypertension that cannot be reduced to normal range after antihypertensive treatment (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90 mmHg).
  • Suffer from myocardial ischemia or myocardial infarction above II grade and poorly controlled arrhythmias (including QTc interval ≥ 470ms in females).
  • According to the NYHA standard, there were previous or present cardiac insufficiency of grade II or above, or color Doppler echocardiography showed that the left ventricular ejection fraction ((LVEF)) was less than 50% or the lower limit of the normal value.
Show all 17Show fewer
  • Abnormal coagulation function (INR>1.5 or prothrombin time (PT) > ULN+4 seconds or APTT>1.5xULN), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy.
  • There were significant clinical bleeding symptoms or definite bleeding tendency in the first 3 months, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood or above, or suffering from vasculitis.
  • Major surgical operations or severe traumatic injuries, fractures or ulcers occurred within the first 4 weeks of randomization.
  • There are significant factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction.
  • Urine routine indicates urinary protein ≥++, or confirms 24-hour urinary protein ≥ 1.0g.
  • The researchers judged other conditions that may affect the conduct of clinical studies and the determination of research results.
  • Allergic or heterogeneous reactions to doxorubicin and / or related substances.
  • The cumulative dose of doxorubicin (including previous anthracycline, if any) is expected to reach or exceed 550 mg after 4 courses of doxorubicin liposome injection treatment.
  • Uncontrollable arrhythmias or electrocardiograms abnormalities determined by the lead researcher to be at risk.
  • A history of doxorubicin liposome therapy in recent half a year.
  • Have previously received local radiotherapy of the pelvis or lower abdomen.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

  • National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100021

  • Beijing Obstetrics and Gynecology Hospital affiliated to Capital Medical University

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality

  • West China Second University Hospital, Sichuan University

    Chengdu, Sichuan, 100021

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • Guangxi Cancer Hospital

    Guangxi, Guangxi

  • Hubei Cancer Hospital

    Hubei, Hubei

  • Hunan Cancer Hospital

    Hunan, Hunan

  • Xiangya Hospital of Central South University

    Hunan, Hunan

  • The first Hospital of Jilin University

    Jilin City, Jilin

  • Liaoning Cancer Hospital

    Liaoyang, Liaoning

  • Shandong Cancer Hospital

    Shangdong, Shangdong

  • Tumor Hospital affiliated to Fudan University

    Shanghai, Shanghai Municipality

  • Tumor Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality

  • Yunnan Cancer Hospital

    Yunnan, Yunnan

Other trials in China

About this study

Official title: Apatinib Combined With PLD vs PLD for Platinum-resistant Recurrent Ovarian Cancer(APPROVE): a Randomized, Controlled, Open-label, Phase 2 Trial

Epithelial ovarian cancer is the most fatal gynecological malignancy. Despite initial therapeutic response, the majority of advanced-stage patients relapse and eventually succumb to chemoresistant disease. The prognosis of patients with platinum-resistant or refractory ovarian cancer was very poor, with the response rate of 20%~25% after chemotherapy. The purpose of treatment for recurrent ovarian cancer is mainly to improve the quality of life of patients and prolong survival. Angiogenesis is essential for tumor growth and metastasis.And VEGF/VEGF receptor(VEGFR) signaling pathway is the most promising angiogenic target due to its key roles in angiogenesis and tumor growth.This study sought to assess the efficacy and safety of the combination therapy of apatinib and PLD, clarifying whether combination therapy could improve the outcomes of patients with platinum-resistant recurrent ovarian cancer.

Read the detailed description

This study is a randomized, parallel-controlled, multicenter clinical study. We recruit patients over the age of 18 years with platinum-resistant recurrent ovarian cancer. patients who meet the criteria for enrollment are randomly divided into two groups, including experiment group and control group. This study will be divided into three stages: 1. Baseline period (within 21 days before the start of treatment): Patients will complete screening tests during the baseline period to assess whether they meet the selection criteria. 2. Treatment period (from the first administration to the completion of the last treatment cycle). The tumor will be evaluated every 8 weeks during this period. If the treatment is effective, the chemotherapy does not exceed 6 cycles，then experiment group receives oral apatinib maintenance therapy until the disease progresses or toxicity could not be tolerated. Control group is followed up. 3. Follow-up period. After the end of chemotherapy, the survival status and follow-up anti-tumor therapy are collected by telephone or research centers visit every 3 months until death or loss of follow-up.The primary endpoint is the progression-free survival time(PFS) of patients and is judged according to Response Evaluation Criteria in Solid Tumors, version 1.1. Adverse events are classified and recorded according to the National Cancer Institute's Standard of Common terms for adverse reactions (NCI-CTCAE) version 4.0.

Being tested
PLD 40mg/m2 ivgtt q4w +Apatinib 250mg po qd, PLD 40mg/m2 ivgtt q4w

What participants receive

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

  • PLD 40mg/m2 ivgtt q4w +Apatinib 250mg po qdDrug

    Patients receive PLD and apatinib at the same time. The dose of intravenous chemotherapy drug is calculated according to the body surface area, and the dose of oral drug apatinib is 250mg qd. Dose suspension and dose reduction are allowed only when patients have serious adverse reactions. The intravenous chemotherapy drug PLD dose is only allowed to be down-regulated twice (one time is to reduce the standard dose by 25%), and the oral drug apatinib dose is only allowed to be reduced once (250mg gravity QD changed to 250mg gravity Qod). Otherwise the patients will drop out of the study.

  • PLD 40mg/m2 ivgtt q4wDrug

    The dose of intravenous chemotherapy drug is calculated according to the body surface area. When patients have serious adverse reactions, dose suspension and dose reduction are allowed. The PLD dose is only allowed to be down-regulated twice (one time is to reduce the standard dose by 25%).

Study groups in NCT04348032
Study groupRoleWhat they receive
PLDActive comparatorPLD 40 mg/m2 D1 ivgtt q4w
Receives: Drug: PLD 40mg/m2 ivgtt q4w
PLD + ApatinibExperimentalPLD 40 mg/m2 D1 ivgtt q4w + Apatinib 250mg po qd
Receives: Drug: PLD 40mg/m2 ivgtt q4w +Apatinib 250mg po qd

What is being measured

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

  1. Progression-free Survival(PFS)

    From date of randomization until the date of first documented progression or died

    Measured: up to 2 years

Secondary outcomes (4)

  1. Overall survival(OS)

    From date of randomization until the date of death from any cause

    Measured: up to 2 years

  2. Objective response rate(ORR)

    The proportion of patients with tumor shrinkage reaching a certain amount and for a certain period of time, including cases of CR PR.

    Measured: up to 2 years

  3. disease control rate(DCR)

    including CR, PR, SD

    Measured: up to 2 years

  4. hematological toxicity and non-hematological toxicity

    including hematological toxicity and non-hematological toxicity

    Measured: up to 2 years

Timeline

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

  1. First posted15 Apr 2020
  2. Study start22 Mar 2018
  3. Primary completion28 Jan 2021
  4. Study completion30 Jun 2022 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04348032
Sponsor's protocol ID
2016YFC1303704
Acronym
APPROVE
Status last verified
Mar 2022
First submitted
14 Apr 2020
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data (IPD) available to other researchers

Publications

  • Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.

    PubMed 37407274

  • Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

    PubMed 37185961

  • Wang T, Tang J, Yang H, Yin R, Zhang J, Zhou Q, Liu Z, Cao L, Li L, Huang Y, Jiang K, Wang W, She F, Guan N, Hou Z, Li N, Wu L. Effect of Apatinib Plus Pegylated Liposomal Doxorubicin vs Pegylated Liposomal Doxorubicin Alone on Platinum-Resistant Recurrent Ovarian Cancer: The APPROVE Randomized Clinical Trial. JAMA Oncol. 2022 Aug 1;8(8):1169-1176. doi: 10.1001/jamaoncol.2022.2253.

    PubMed 35771546

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PLD 40mg/m2 ivgtt q4w +Apatinib 250mg po qd and PLD 40mg/m2 ivgtt q4w in people with Platinum-resistant Recurrent Ovarian Cancer, run by Chinese Academy of Medical Sciences at 16 sites 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 15 inclusion and 17 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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?

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?

Progression-free Survival(PFS) (time frame: up to 2 years). 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 NCT04348032, which also lists 3 linked publications.

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 31 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in