AzTrials
AzTrials

Ovarian CancerPhase 2NCT03298074

Apatinib Plus Etoposide Versus Etoposide Alone for Platinum-resistant Recurrent Ovarian Cancer

A Phase 2 study testing Apatinib and Etoposide in people with Ovarian Cancer, run by Yang Zhijun.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

It is a prospective multi-center trial, platinum-resistant ovarian cancer patients will be randomized in two groups, one group will be treated with Apatinib plus Etoposide, the other will be treated with Etoposide alone. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Apatinib and Etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Oct 2017to Apr 2019
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

  • ECOG PS：0-2 points
  • Platinum-resistant recurrent ovarian cancer patients with measurable recurrent focus
  • The damage caused by other treatment has been restored (NCI-CTCAE 4.0 Graded ≤ 1 level), Other cytotoxic drugs treatment, radiotherapy or surgery≥ 4 week; EGFR TKI treatment ≥ 2 week
  • Baseline routine blood test and biochemical indicators meet the following criteria:
  • Hemoglobin ≥ 90g / L
  • Neutrophil absolute count (ANC) ≥ 1.5 × 109 / L
Show all 13Show fewer
  • Platelets ≥80 × 109 / L
  • ALT, AST ≤ 2.5 × ULN or 5 × ULN (with liver metastases)
  • Total Serum bilirubin ≤ 1.5 × ULN
  • Serum creatinine≤1.5×ULN or endogenous creatinine clearance ≥ 45ml/min (according to Cockcroft-Gault formula);
  • No blood and blood products transfusion in 14 Days
  • Expected survival time≥3 month;
  • Subjects volunteer to join the study, sign informed consent, cooperate with follow-up.

Who cannot join

  • "biochemical recurrence " ovarian cancer patients
  • Patients allergy to apatinib, etoposide and / or its excipients
  • Patients with high blood pressure and who can not be reduced to normal range by antihypertensive therapy (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg), with grade I coronary heart disease, grade I arrhythmia (including QTc prolongation > 470 ms)
  • According to NYHA standard, grade Ⅲ-Ⅳ heart failure, or cardiac color Doppler ultrasound examination shows left ventricular ejection fraction (LVEF) <50%
  • Urine protein positive patients
  • With a variety of factors that affect oral medication (such as can not swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.)
Show all 21Show fewer
  • Patients with definite gastrointestinal bleeding tendencies, including the following: localized ulcer lesions, and fecal occult blood (++); 2 months with black stool, hematemesis history
  • Patients with coagulation dysfunction (INR> 1.5, APTT> 1.5 ULN), bleeding tendency
  • Existing hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.)
  • Long untreated wound or fracture;major surgery or severe traumatic injury in 4 weeks, fracture or ulcer
  • Accompanied by abdominal fistula, gastrointestinal perforation or abdominal abscess; active hepatitis B virus or hepatitis C patients
  • Active brain metastases, cancer meningitis, spinal cord compression patients, Imaging CT or MRI examination found the brain or pia mater disease,( brain metastases patients who has complete treatment 21 days before and has stable symptoms can be enrolled , but the need for transcranial MRI, CT or intravenous angiography evaluation confirmed as no cerebral hemorrhage symptoms)
  • Imaging (CT or MRI) shows tumor lesions from large vessels ≤ 5 mm, or lesions invade the Local large blood vessels
  • Lactating women
  • Patients with other malignancies in 5 years (except for cured skin basal cell carcinoma and in situ ovarian cancer)
  • Patients with a history of psychiatric abuse and who can not quit or have mental disorders
  • Patients who participated in other drug clinical trials within 4 weeks
  • Patients who received VEGFR inhibitors such as sorafenib and sunitinib treatment
  • Patients who received Etoposide treatment
  • According to the researcher's judgment, there are serious illnesses that endanger the patient's safety or affect the completion of the study
  • Patients that are not suitable for this trial in the investigator's opinions.

Trial locations and contacts

No sites are listed yet.

Zhijun Yang contact

8618994127461

18994127461@163.com

About this study

Official title: Apatinib Plus Etoposide Versus Etoposide Alone for Platinum-resistant Recurrent Ovarian Cancer: A Randomized Controlled Trial

It is a prospective multi-center trial, platinum-resistant ovarian cancer patients will be randomized in two groups, one group will be treated with Apatinib plus Etoposide, the other will be treated with Etoposide alone. It is aimed to see the efficacy and safety of Apatinib plus Etoposide for the platinum-resistant ovarian cancer patients

Read the detailed description

It is a randomized controlled trial, the aim is to see the efficacy and safety of Apatinib plus Etoposide treating platinum-resistant ovarian cancer. The main primary end point is DCR (disease control rate), the secondary endpoint is Duration of response（DOR），overall survival (OS), time to progression (TTP)，quality of life (QoL, according to EORTC QLQ-C30).The key safety indicators include the patients' vital signs, laboratory indicators, adverse events(AE),serious adverse events.

The data collection duration is from the day ICF assigned to the day(30 days after the end of the last medication).From the day ICF signed to the end of the study, all adverse events were recorded in the CRF. The severity of the adverse events will be evaluated according to the NCI CTCAE 4.0 standard.Each patient will receive a planned visit and specific data at different points will be recorded in the visit.

The patients will be followed up after quitting the trial because of disease progression or intolerance. The following parameters were recorded during follow-up: disease recurrence,metastasis,death time,SAE occurred during the study; survival (available with telephone follow-up, record required).

Adverse events that have not been recovered when the drug is discontinued should be tracked and finalized. All patients should undergo a 30-day follow-up after the last medication to find any new adverse events.

All cases should be recorded carefully and completely, the investigator should be responsible for the authenticity of the center's data.

During the clinical trial, the inspector should send the CRF to the data management unit (in batches), the data administrator will carry out the independent double entry, and carry out the double verification.

The trial as an exploratory test, using a small sample comparison, the test plans to enroll a total of 60 cases.

The statistical analysis plan includes case analysis,demographic data and baseline analysis,efficacy analysis and safety analysis.All statistical tests will be performed on both sides, the difference between the tests was considered statistically significant with a P value less than or equal to 0.05,

Conditions
Ovarian Cancer
Being tested
Apatinib, Etoposide
Keywords
platinum-resistant, recurrent
Medical subject headings
Ovarian Neoplasms, Recurrence

What participants receive

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

  • ApatinibDrug

    Also called Aitan

    Apatinib, 500mg,po qd for continuous administration

  • EtoposideDrug

    Etoposide,100mg, PO.QD，D1-D10, Q3W

Study groups in NCT03298074
Study groupRoleWhat they receive
Apatinib plus EtoposideExperimentalApatinib,500mg,PO.QD, continuous administration Etoposide,100mg, PO.QD，D1-D10, Q3W
Receives: Drug: Apatinib; Drug: Etoposide
EtoposideActive comparatorEtoposide,100mg, PO.QD，D1-D10, Q3W
Receives: Drug: Etoposide

What is being measured

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

  1. Disease Control Rate

    the proportion of patients who had a best response rating of complete response, partial response, or stable disease

    Measured: through study completion, an average of 1.5 years

Secondary outcomes (3)

  1. Duration of Response

    the time course from the first time tumor assessed as CR or PR to the first time tumor assessed as progressive disease or death

    Measured: through study completion, an average of 1.5 years

  2. Overall Survival

    From the beginning of randomization to the cause of death for any reason

    Measured: through study completion, an average of 3 years

  3. Time to Progression

    From randomization to the onset of disease progression or death

    Measured: through study completion, an average of 1.5 years

Timeline

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

  1. First posted29 Sep 2017
  2. Study startOct 2017 (estimated)
  3. Primary completionOct 2018 (estimated)
  4. Study completionApr 2019 (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
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03298074
Sponsor's protocol ID
HRGX-001
Status last verified
Sep 2017
First submitted
27 Sep 2017
Last updated
29 Sep 2017
Results posted
No
Data monitoring committee
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 Apatinib and Etoposide in people with Ovarian Cancer, run by Yang Zhijun.

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 13 inclusion and 21 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 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

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 Zhijun Yang (8618994127461, 18994127461@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control Rate (time frame: through study completion, an average of 1.5 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 NCT03298074.

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 29 Sep 2017.

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