Renal Cell CarcinomaPhase 2NCT02072044
Phase II Study of Anlotinib in Patients With Advanced Renal Cell Carcinoma That Have Failed Or Are Intolerant To TKIs Therapy
A Phase 2 study testing Anlotinib in people with Renal Cell Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 15 sites in China.
Trial summary
Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 15 sitesChina
- Study dates
- Dec 2013to Dec 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
- 1.Patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery
- 2.Previously Failed Or Are Intolerant To TKIs Therapy(such as sunitinib, Sorafenib)
- 3.With measurable disease (using RECIST1.1)
- 4.18-75years,ECOG PS:0-1,Life expectancy of more than 3 months
- 5.Last TKIs Therapy≥4 weeks
- 6.Main organs function is normal
- 7.Signed and dated informed consent
Who cannot join
- 1.patients has many influence factors toward oral medications
- 2.Known brain metastases
- 3.patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG)>10mmol/L);urine protein≥++,etc.
- 4.patients failed to heal wounds or fractures for Long-term
- 5.patients occurred venous thromboembolic events within 6 months
- 6.patients has HIV-positive or organ transplantation
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Jilin Cancer Hospital
Changchun, Jilin, 132000
West China Hospital，Sichuan University
Chengdu, Sichuan, 610041
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 404100
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510000
Harbin medical university affiliated tumor hospital
Haerbin, Heilongjiang, 150000
Qilu Hospital，Shandong University
Jinan, Shandong, 250012
Gansu Province Tumor Hospital
Lanzhou, Gansu, 730050
The 81st Hospital of Chinese PLA
Nanjing, Jiangsu, 210000
Guangxi medical university affiliated tumor hospital
Nanning, Guangxi, 530021
Cancer Hospital of Fudan University
Shanghai, Shanghai Municipality, 200000
China General Hospital of Shenyang Military Region
Shenyang, Liaoning, 110000
Liaoning Province Tumor Hospital
Shenyang, Liaoning, 110042
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, 300000
About this study
Official title: A Phase II Study of Anlotinib(AL3818) in Patients With Advanced Renal Cell Carcinoma(RCC) That Have Failed Or Are Intolerant To TKIs Therapy
Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to explore the efficacy and safety profile of Anlotinib in patients with advanced Renal Cell Carcinoma(RCC) that have failed to TKIs therapy.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Anlotinib
- Keywords
- Renal Cell Carcinoma（RCC）, Anlotinib
- 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.
AnlotinibDrug
Anlotinib p.o. qd
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib | Experimental | Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress Free Survival (PFS)
The PFS time is defined as time from randomization to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of: "death", "last tumor assessment", "last follow up date" or "last date in drug log"
Measured: each 42 days up to PD or death (up to 36 months)
Secondary outcomes (3)
Objective Response Rate
To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles. Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.
Measured: each 42 days up to intolerance the toxicity or PD (up to 36 months)
Disease Control Rate (DCR)
To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles. Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease).
Measured: each 42 days up to intolerance the toxicity or PD (up to 36 months)
Overall Survival (OS)
OS was defined as time from date of randomization to date of death due to any cause. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.
Measured: From randomization until death (up to 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072044
- Sponsor's protocol ID
- ALTN-06-IIB
- Status last verified
- Aug 2017
- First submitted
- 20 Jan 2014
- Last updated
- 29 Dec 2017
- Results posted
- No
Publications
Ma J, Song Y, Shou J, Bai Y, Li H, Xie X, Luo H, Ren X, Liu J, Ye D, Bai X, Fu C, Qin S, Wang J, Zhou AP. Anlotinib for Patients With Metastatic Renal Cell Carcinoma Previously Treated With One Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitor: A Phase 2 Trial. Front Oncol. 2020 May 7;10:664. doi: 10.3389/fonc.2020.00664. eCollection 2020.
PubMed 32457838
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Anlotinib(AL3818) in Patients With Advanced Renal Cell Carcinoma(RCC) That Have Failed Or Are Intolerant To TKIs Therapy
- ClinicalTrials.gov ID
- NCT02072044
- Acronym / sponsor ID
- ALTN-06-IIB
- Conditions
- Renal Cell Carcinoma
- Keywords
- Renal Cell Carcinoma（RCC）, Anlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 26 Feb 2014 (estimated)
- 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.
Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to explore the efficacy and safety profile of Anlotinib in patients with advanced Renal Cell Carcinoma(RCC) that have failed to TKIs therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib | Experimental | Drug: AnlotinibAnlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1.Patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery
- 2.Previously Failed Or Are Intolerant To TKIs Therapy(such as sunitinib, Sorafenib)
- 3.With measurable disease (using RECIST1.1)
- 4.18-75years,ECOG PS:0-1,Life expectancy of more than 3 months
- 5.Last TKIs Therapy≥4 weeks
Key exclusion criteria (6 listed)
- 1.patients has many influence factors toward oral medications
- 2.Known brain metastases
- 3.patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG)>10mmol/L);urine protein≥++,etc.
- 4.patients failed to heal wounds or fractures for Long-term
- 5.patients occurred venous thromboembolic events within 6 months
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 |
|---|---|---|
| AnlotinibAnlotinib p.o. qd | Drug | Anlotinib |
Primary outcome
Progress Free Survival (PFS)
Time frame: each 42 days up to PD or death (up to 36 months)
The PFS time is defined as time from randomization to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of: "death", "last tumor assessment", "last follow up date" or "last date in drug log"
3 secondary outcomes
Objective Response Rate
Time frame: each 42 days up to intolerance the toxicity or PD (up to 36 months)
Disease Control Rate (DCR)
Time frame: each 42 days up to intolerance the toxicity or PD (up to 36 months)
Overall Survival (OS)
Time frame: From randomization until death (up to 36 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
- Derived from this study: PubMed 32457838Ma J, Song Y, Shou J, Bai Y, Li H, Xie X, Luo H, Ren X, Liu J, Ye D, Bai X, Fu C, Qin S, Wang J, Zhou AP. Anlotinib for Patients With Metastatic Renal Cell Carcinoma Previously Treated With One Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitor: A Phase 2 Trial. Front Oncol. 2020 May 7;10:664. doi: 10.3389/fonc.2020.00664. eCollection 2020.
- CancerLink provided by the sponsor.
- Drug InformationLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib in people with Renal Cell Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 15 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 7 inclusion and 6 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 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Progress Free Survival (PFS) (time frame: each 42 days up to PD or death (up to 36 months)). 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 NCT02072044, which also lists 1 linked publication.
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 Dec 2017.