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Metastatic Renal Cell CarcinomaPhase 2NCT02774200

A One-arm Exploratory Clinical Research Program Study of Apatinib in Advanced Metastatic Renal Cell Carcinoma Patients.

A Phase 2 study testing Apatinib in people with Metastatic Renal Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

A one-arm exploratory clinical research program Study of Apatinib in Advanced Metastatic Renal Cell Carcinoma （mRCC） Patients.It's arm to evaluate the treatment of advanced metastatic renal cell carcinoma in patients with objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS)… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Renal Cell Carcinoma
What is being tested?
Apatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
May 2016to Jun 2017
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years to 75 years
  • Histologically or cytologically confirmation with a renal clear cell histologic component and metastases
  • Presence of a single diameter measurable lesions (eg, ≥1 malignant tumors with at least one single diameter can be accurately measured, conventional computer tomography scan [CT] or magnetic resonance [MRI] requires at least one path ≥20mm, if the interphase reconstruction of spiral computed tomography scan ≤5mm [CT], at least one path ≥10mm). Bone lesions, ascites, peritoneal metastasis or miliary lesions, pleural or pericardial effusion, skin or lung lymphangitis, cystic lesion or lesions after radiotherapy is not measurable lesion
  • Life expectancy more than 3 months
  • The progress of the disease must be according to RECIST criteria (version 1.0) after a previous systemic treatment of first-line metastatic renal cell carcinoma. Previous treatment program includes one or more of the following drugs: Sunitinib, Sorafenib, Bevacizumab + Interferon-α (IFN-α), Temsirolimus or Cytokine;
  • Adequate organ function, defined as follows: the absolute number of Neutrophil (ANC) same or more than 1500 cells / mm3; Platelet same or more than 75,000 cells / mm3; Hemoglobin same or more than 9.0 g / dL; Aspartate aminotransferase（AST）and alanine aminotransferase (ALT) same or less than equal 2.5 x upper limit normal (xULN), if liver metastases, Aspartate aminotransferase (AST) and ALT same or less than 5.0 times ULN;Total bilirubin same or less than 1.5 times ULN，Serum Creatinine same or less than 1.5 times ULN, Creatinine clearance same or more than 60 mL/min, Urinary dipstick proteinuria <2+. If the urine protein same or more than 2+, the need for 24-hour urinary protein excretion, and 24-hour urine protein <2 g
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  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • The prior systemic therapy, radiation therapy, surgery at least two weeks apart (bevacizumab + IFN-α therapy for at least 4 weeks apart), all treatment-related toxicity recovered to ≤1 grade defined according to 3.0 versions of NCI CTCAE defined, or recovered to baseline levels, except for alopecia, or hypothyroidism
  • The measured value of twice baseline blood pressure (interval of at least 1 hour) show inexistent Hypertension that cannot be controlled by medication. Baseline systolic blood pressure should be same or less than 140 mm Hg, baseline diastolic blood pressure should be same or less than 90 mm Hg. Patients with antihypertensive drugs can be controlled by the group
  • For the fertility of women ,the serum or urine pregnancy test must be negative within pre-treatment three days
  • Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
  • Patient consent and well compliance, scheduled to accept the visits, treatment, laboratory tests and other study procedures

Who cannot join

  • Patients who received more than one first-line for the Metastatic Renal Cell Carcinoma (mRCC) systemic treatment
  • Patients who received any neoadjuvant or adjuvant systemic treatment
  • Begin to study 4 weeks later than major surgery treatment time, or 2 weeks later than radiotherapy. Allow received palliative radiotherapy for metastatic lesion, but at least one measurable lesions did not receive radiation therapy
  • The gastrointestinal tract anomalies
  • unable to take oral medication
  • require intravenous nutrition
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  • previous surgical treatment influence drug absorption include total gastrectomy
  • In the past six months have been treated for active ulcer disease
  • In the past three months with cancer unrelated activities gastrointestinal bleeding, including vomiting blood, blood in the stool or black stools, endoscopy or colonoscopy colon without evidence of remission
  • malabsorption syndrome.
  • Currently accepted or may need to accept treatment with potent CYP3A4 inhibitors (eg, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, blessing Secretary amprenavir and delavirdine)
  • Currently accepted or may need to accept CYP3A4 or CYP1A2 inducer treatment (eg, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine , primidone, rifabutin, rifampicin, Hypericum perforatum)
  • Need to accept the oral vitamin K antagonists of anticoagulant therapy. Allows the use of low dose of anticoagulant drugs to remain central venous channel unobstructed and prevention of deep vein thrombosis. Allow treatment dose low molecular heparin
  • Active epilepsy or brain metastases, spinal cord compression or meningitis carcinomatosa
  • Patients who have unable to control the disease or active infection
  • Situation appeared within 12 months before with the study drug: myocardial infarction, uncontrolled angina, coronary artery/peripheral artery bypass grafting, with symptoms of congestive heart failure, cerebrovascular accident, transient ischemic attack, deep vein thrombosis or pulmonary embolism within 6 months
  • Known history of Human Immunodeficiency Virus(HIV) positive or Immune Deficiency Syndrome(AIDS) related diseases
  • Medical History:Have other malignant tumors (except renal cell carcinoma), not including treatable form of skin cancer (non malignant melanoma), breast carcinoma in situ or cervical carcinoma in situ, or any other tumors has been cured, and no evidence of disease recurrence within 2 years
  • Patients who are dementia or obvious mental retardation
  • Women with pregnancy or lactation, or fertility but during treatment and 6 months after treatment of termination unwilling or unable to use effective contraception to avoid pregnancy patients with male or female
  • With other serious acute and chronic physical or mental illness or abnormal laboratory tests, according to the judgment may increase the risk of to participate in research or related to drug treatment, or may affect the interpretation of the results, or other situations that the researchers considered unsuitable for this study

Trial locations and contacts

No sites are listed yet.

Xin Yao, P.H.D. contact

13803000688

yaoxin@tjmuch.com

About this study

Official title: A One-arm Exploratory Clinical Research Program Study of Apatinib in Advanced Metastatic Renal Cell Carcinoma Patients

A one-arm exploratory clinical research program Study of Apatinib in Advanced Metastatic Renal Cell Carcinoma （mRCC） Patients.It's arm to evaluate the treatment of advanced metastatic renal cell carcinoma in patients with objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), quality of life score (QoL) and safety.

Read the detailed description

Objective response rate (ORR), disease control rate (DCR) (according to RECIST 1.1 Standard Edition)，progression-free survival (PFS), overall survival (OS), quality of life (QoL).Evaluation once every 8 weeks, If the efficacy results of the evaluation are complete response (CR) or partial response (PR), confirmed imaging efficacy at 4 weeks after the initial assessment ， efficacy evaluation time window of ± 7 days.

Being tested
Apatinib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • ApatinibDrug

    Also called Apatinib Mesylate Tablets

    Apatinib 500 mg, po, qd, continuous medication for a period of eight weeks.

Study groups in NCT02774200
Study groupRoleWhat they receive
test groupExperimentalApatinib 500 mg, po, qd, continuous medication for a period of eight weeks.
Receives: Drug: Apatinib

What is being measured

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

  1. objective response rate (ORR)

    Measured: 8 weeks

Secondary outcomes (3)

  1. progression-free survival (PFS)

    Measured: 8 weeks

  2. overall survival (OS)

    Measured: 8 weeks

  3. quality of life score (QoL)

    Measured: 8 weeks

Timeline

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

  1. First posted17 May 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionDec 2016 (estimated)
  4. Study completionJun 2017 (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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02774200
Sponsor's protocol ID
AHEAD-HBR001
Status last verified
Mar 2016
First submitted
11 May 2016
Last updated
17 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib in people with Metastatic Renal Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.

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 12 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 17 May 2016. 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 Xin Yao, P.H.D. (13803000688, yaoxin@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate (ORR) (time frame: 8 weeks). 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 NCT02774200.

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 17 May 2016.

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