Metastatic Colorectal CancerPhase 2/3ALTER0703NCT02332499
Study of Anlotinib in Patients With Metastatic Colorectal Cancer（mCRC）(ALTER0703)
A Phase 2/3 study testing Anlotinib in people with Metastatic Colorectal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 29 sites in China.
Trial summary
The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Anlotinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 419 participants
- Where
- 29 sitesChina
- Study dates
- Dec 2014to 1 Mar 2019
- Phase
- Phase 2/3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent；
- Histological or cytological documentation of adenocarcinoma of the colon or rectum；
- Subjects with metastatic colorectal cancer (Stage IV),With measurable disease (using RECIST1.1)；
- Progression during or within 3 months following the last administration of approved standard therapies which must include Fluorouracil or its derivatives, Oxaliplatin, Irinotecan；
- ECOG PS:0-1,Life expectancy of more than 3 months；
- main organs function is normal；
- main organs function is normal；
Who cannot join
- Prior treatment with Anlotinib；
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug；
- Known brain metastases；
- patients with severe and failed to controlled diseases；
- patients occurred venous thromboembolic events within 6 months；
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
China29 sites
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Peking Union Medical College Hospital
Beijing, Beijing Municipality
The 307th Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality
The 1st Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
Jilin Cancer Hospital
Changchun, Jilin
The Second xiangya Hospital of Central South University
Changsha, Hunan
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Fujian Cancer Hospital
Fuzhou, Fujian
The First Affiliated Hospital of Sun Yat-sen university
Guangzhou, Guangdong
The Sixth Affiliated Hospital of Sun Yat-sen university
Guangzhou, Guangdong
Harbin medical university affiliated tumor hospital
Haerbin, Heilongjiang, 150000
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
The Second Affiliated Hospital, Anhui Medical University
Hefei, Anhui
Qilu Hospital，Shandong University
Jinan, Shandong
Gansu Province Tumor Hospital
Lanzhou, Gansu
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu
Jiangxi Cancer Hospital
Nanchang, Jiangxi
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Jiangsu Cancer Hospital
Nanjing, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu
Guangxi medical university affiliated tumor hospital
Nanning, Guangxi
Nantong Cancer Hospital
Nantong, Jiangsu
Cancer Hospital of Fudan University
Shanghai, Shanghai Municipality
Liaoning Province Tumor Hospital
Shenyang, Liaoning
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality
Shanxi Cancer Hospital
Xian, Shanxi
Tangdu Hospital of The fourth Military Medical University
Xian, Shanxi
The First Affiliated Hospital of Xian Jiaotong University
Xian, Shanxi
About this study
Official title: Randomized,Double-blind,Placebo-controlled,Multicenter Study to Compare the Efficacy and Safety of Anlotinib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies(ALTER0703)
The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.
Read the detailed description
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.To compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Anlotinib, Placebo
- Keywords
- Anlotinib, Metastatic Colorectal Cancer （mCRC）, ALTER0703
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
Also called AL3818
Anlotinib p.o. qd
PlaceboDrug
Placebo p.o. qd
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib | Active comparator | Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Drug: Anlotinib |
| Placebo | Placebo comparator | Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: From randomization until death (up to 24 months)
Secondary outcomes (4)
Progress free survival (PFS)
Measured: each 42 days up to PD or death(up to 24 months)
Objective Response Rate (ORR)
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Until 30 day safety follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startDec 2014
- Primary completion18 Aug 2016
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yihebali Chi, doctor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical SciencesJianqiang Cai, doctor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical SciencesJinwan Wang, doctor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332499
- Sponsor's protocol ID
- ALTN-07-IIB
- Acronym
- ALTER0703
- Status last verified
- May 2019
- First submitted
- 31 Dec 2014
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized,Double-blind,Placebo-controlled,Multicenter Study to Compare the Efficacy and Safety of Anlotinib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies(ALTER0703)
- ClinicalTrials.gov ID
- NCT02332499
- Acronym / sponsor ID
- ALTER0703 / ALTN-07-IIB
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Anlotinib, Metastatic Colorectal Cancer （mCRC）, ALTER0703
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- 18 Aug 2016 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 6 Jan 2015 (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.
The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.
Detailed description
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.To compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib | Active comparator | Drug: AnlotinibAnlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed and dated informed consent；
- Histological or cytological documentation of adenocarcinoma of the colon or rectum；
- Subjects with metastatic colorectal cancer (Stage IV),With measurable disease (using RECIST1.1)；
- Progression during or within 3 months following the last administration of approved standard therapies which must include Fluorouracil or its derivatives, Oxaliplatin, Irinotecan；
- ECOG PS:0-1,Life expectancy of more than 3 months；
Key exclusion criteria (5 listed)
- Prior treatment with Anlotinib；
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug；
- Known brain metastases；
- patients with severe and failed to controlled diseases；
- 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 |
|---|---|---|
| AnlotinibAlso: AL3818Anlotinib p.o. qd | Drug | Anlotinib |
| PlaceboPlacebo p.o. qd | Drug | Placebo |
Primary outcome
Overall Survival (OS)
Time frame: From randomization until death (up to 24 months)
4 secondary outcomes
Progress free survival (PFS)
Time frame: each 42 days up to PD or death(up to 24 months)
Objective Response Rate (ORR)
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Until 30 day safety follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- CancerLink provided by the sponsor.
- Colorectal CancerLink provided by the sponsor.
- U.S. FDA ResourcesLink provided by the sponsor.
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CRC
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.
Yihebali Chi, doctor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Jianqiang Cai, doctor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Jinwan Wang, doctor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Anlotinib in people with Metastatic Colorectal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 29 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 5 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: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall Survival (OS) (time frame: From randomization until death (up to 24 months)). 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 21 May 2019.