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AzTrials

Colorectal NeoplasmsPhase 2NCT03190616

Apatinib in Refractory Colorectal Cancer

A Phase 2 study testing apatinib in people with Colorectal Neoplasms, run by The First Affiliated Hospital with Nanjing Medical University at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Limited agents have been approved after standard first and second line treatment. Regorafenib and Trifluridine/Tipiracil (TAS-102) are still not approved in China.Apatinib has shown significant efficacy in refractory advanced gastric cancer regarding PFS and OS with controllable toxicity.This study is aimed to explore… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Neoplasms
What is being tested?
apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
4 sitesChina
Study dates
1 Jul 2017to 30 Dec 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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
  • Subjects with metastatic colorectal cancer(CRC) (Stage IV).
  • Subjects must have failed at least two lines of prior treatment, which must include a fluoropyrimidine, oxaliplatin and irinotecan.
  • Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy.
  • Subjects who have withdrawn from standard treatment due to unacceptable toxicity and precluding retreatment with the same agent prior to progression of disease will also be allowed.
  • Prior treatment with bevacizumab and/or cetuximab will be allowed.
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  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.is necessary.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
  • Life expectancy of at least 3 months.
  • Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.
  • assigned informed consent.

Who cannot join

  • Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
  • Participants of other clinical trial within 4 weeks.
  • Diseases which will impact the absorption of apatinib, eg. dysphagia, chronic diarrhea, bowl obstruction
  • Hemorrhage events of ≥grade 3 within 4 weeks.
  • known central nervous system metastasis.
  • Uncontrolled hypertension. (Systolic blood pressure 140 mmHg or diastolic pressure 90 mmHg despite optimal medical management). Unstable angina,congestive heart failure,Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.
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  • urine protein ≥++ and 24h urine protein more than 1.0g.
  • Chronically green wound or bone fracture.
  • Arterial or venous thrombotic or embolic events.
  • Tumor invading important blood vessel with high risk of severe hemorrhage.
  • Abnormal coagulation function.
  • thromboemboli events within 6 months.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • the second hospital of Changzhou city

    Changzhou, Jiangsu, 213000

  • Nanjing 81 Hospital

    Nanjing, Jiangsu, 210000

  • the first affiliated hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

  • Jiangnan University affiliated hospital

    Wuxi, Jiangsu, 214000

Other trials in China

About this study

Official title: A Single Arm, Open Label, Multicenter Exploratory Study of Apatinib in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Second Line Therapy

Limited agents have been approved after standard first and second line treatment. Regorafenib and Trifluridine/Tipiracil (TAS-102) are still not approved in China.Apatinib has shown significant efficacy in refractory advanced gastric cancer regarding PFS and OS with controllable toxicity.This study is aimed to explore the efficacy,safety as well as predictive biomarker in advanced colorectal cancer failed to standard therapy in Chinese population.

Being tested
apatinib
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • apatinibDrug

    Also called YN968D1

    apatinib 500mg/qd, 28d/cycle

Study groups in NCT03190616
Study groupRoleWhat they receive
drug,apatinibExperimentalapatinib 500mg/qd, 28d/cycle
Receives: Drug: apatinib

What is being measured

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

  1. Progression-free Survival(PFS)

    PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.

    Measured: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019

Secondary outcomes (6)

  1. Overall Survival (OS)

    OS is defined as the time from date of assignment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

    Measured: From assignment of the first subject until 40 death events observed, up to 2 years.

  2. Disease control rate (DCR)

    DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD)

    Measured: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019

  3. Objective response rate(ORR)

    The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)

    Measured: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019

  4. Quality of life

    The general well-being of participants, outlining negative and positive features of life.

    Measured: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019

  5. relationship between the tumor molecular burden & gene mutation and the drug efficacy.

    The tumor molecular clones and gene mutations of 1021 tumor related genes will be detected by next-generation sequencing,which will be matched with the CT scanning .

    Measured: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019.

  6. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    adverse events will be assessed according to CTCAE v4.0, including hematological and non-hematological adverse events. Non-hematological adverse events will be collected by patients reported outcomes questionaire. The adverse events of interest include hypertension,hand-foot syndrome,proteinuria,hoarseness,rash,etc.The dose reduction and drug discontinuance due to adverse events will also be recorded.

    Measured: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019.

Timeline

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

  1. First posted19 Jun 2017
  2. Study start1 Jul 2017
  3. Primary completion30 Jun 2019
  4. Study completion30 Dec 2019

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
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03190616
Sponsor's protocol ID
KEEP-G 01
Status last verified
Jan 2020
First submitted
1 Mar 2017
Last updated
14 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.

    PubMed 26884585

  • Li J, Qin S, Xu J, Guo W, Xiong J, Bai Y, Sun G, Yang Y, Wang L, Xu N, Cheng Y, Wang Z, Zheng L, Tao M, Zhu X, Ji D, Liu X, Yu H. Apatinib for chemotherapy-refractory advanced metastatic gastric cancer: results from a randomized, placebo-controlled, parallel-arm, phase II trial. J Clin Oncol. 2013 Sep 10;31(26):3219-25. doi: 10.1200/JCO.2013.48.8585. Epub 2013 Aug 5.

    PubMed 23918952

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing apatinib in people with Colorectal Neoplasms, run by The First Affiliated Hospital with Nanjing Medical University at 4 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 11 inclusion and 12 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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

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?

Progression-free Survival(PFS) (time frame: From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019). 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 NCT03190616, which also lists 2 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 14 Jan 2020.

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