Metastatic Colorectal CancerPhase 2NCT01386242
Recombinant Anti-tumor and Anti-virus Protein for Injection in Treatment of Metastatic Colorectal Cancer
A Phase 2 study testing Recombinant anti-tumor and anti-virus protein for injection and Saline Injection in people with Metastatic Colorectal Cancer, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection in treating patients with metastatic colorectal cancer after failure of second-line and more than second-line treatment. 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?
- Recombinant anti-tumor and anti-virus protein for injection and Saline Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- May 2011to May 2014
- 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
- Aged above 18 years.
- ECOG performance status 0, 1 or 2.
- Pathologically confirmed metastatic colorectal cancer.
- Failure of Second-Line or Above Treatment, and irinotecan- and oxaliplatin--containing regimens (If recurrence and metastasis occurred within 6 months after discontinuation of adjuvant chemotherapy, the adjuvant chemotherapy is considered to be first-line treatment). more than 4 weeks before enrollment after discontinuation of chemotherapy.
- Minimum of 4 weeks since any local radiotherapy or surgery for the control of symptoms or severe complications(local radiotherapy for the control of bone metastases is not the limit)，and adequately recovered from toxicities of any prior therapy).
- At least one measurable lesion according to the RECIST criteria that has not been previously local treated. Minimum indicator lesion size as follows: greater than or equal to 10 mm measured by spiral CT or NMR.
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- The organ function is normal (laboratory test results came within 1 week before administration in the absence of ongoing supportive care): ANC ≥ 1.5 x 109/L, Platelets ≥ 80 x 109/L, Hgb ≥ 8.5 g/dL, serum total bilirubin ≤ 1.5 x upper limit of normal (ULN), and serum AST and ALT ≤ 2.5 x ULN(≤ 5 x ULN if liver metastases), serum creatinine ≤1.5 x ULN.
- Have been fully aware of the study and voluntarily signed the informed consent.
- Life expectancy of at least 3 months.
Who cannot join
- Pregnancy or breast-feeding women or women who may be pregnant were positive drug test before administration.
- Patient of child-bearing potential(male or less than 1 year postmenopausal women) were reluctant to take contraceptive measures.
- Patient who were allergic to Interferon-α or who had interferon-α antibody.
- Patients with uncontrolled central nervous system (CNS) metastases.
- Patient with any other Malignant tumors within five years (except for a complete cure of carcinoma in situ of the cervix or basal cell cancer or squamous cell skin cancer).
- Patient with Clinically uncontrolled active infection such as acute pneumonia, active hepatitis B, etc.
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- Patient associated with Significant Systemic illness including, but not limited to, the following: cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, acute myocardial infarction, unstable angina, Congestive heart failure ,serious dysrhythmias, metabolic diseases, thrombosis or thromboembolic events occurred(including transient ischemic attack) in the last 6 months.
- Patient with serious autoimmune diseases in the past or at present, such as systemic lupus erythematosus, rheumatoid arthritis, thyroiditis, etc.
- Patient with ascites, pleural and pericardial effusion that cannot be controlled by drainage or symptomatic treatment.
- Investigator think Patient is not appropriate to participate in this trial for any clinical or laboratory abnormalities, or patient with any grade ≥ 2 toxicity according to NCI CTC AE 3.0 standard .
- Patient who also are accepting other systemic anti-tumor therapy (local radiotherapy for the control of bone metastases is not the limit)), in this study received 4 weeks before the start of drug treatment of other tests.
- Patient who had serious psychological or psychiatric disorder or Drug addiction or alcohol dependence.
- Patient who are estimated to be lack of compliance in this study.
- Patient with acute or subacute intestinal obstruction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II/III Study of Recombinant Anti-tumor and Anti-Virus Protein for Injection Compared With Placebo in Metastatic Colorectal Cancer After Failure of Second-Line and More Than Second-line Treatment
The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection in treating patients with metastatic colorectal cancer after failure of second-line and more than second-line treatment.
Read the detailed description
Explanation for study design
The trial including two stages. The first is an exploration stage to decide delivery frequency and dose of study drug. It is single-blinded, subjects will be randomly divided into 4 groups with a 2:2:2:1 ratio. Study drug given twice per week or 3 times per, dose of the drug are from 20μg to 40μg. The sample size is 105, duration is 12 to 18 months. Based on preliminary efficacy and safety, the better dosage regimen will decided for the second stage.The second stage is double-blinded,subject will be randomly divided into treatment group or placebo group with 2:1 ratio and sample size is 600.
Primary purpose
To compare overall survival between study drug and placebo groups .
Secondary purpose
- Progression free survival were compared in both groups.
- Disease control rate were compared in both groups.
- Quality of life scores were compared in both groups.
- Determine the safety and tolerance of recombinant anti-tumor and anti-virus protein for injection
- Supplementary pharmacodynamics of recombinant anti-tumor and anti-virus protein for injection
Exploratory purpose Evaluate effects of recombinant anti-tumor and anti-virus protein for injection on the anti-tumor immunity, angiogenesis, apoptosis, cell proliferation, immune cells and cytokines levels.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Recombinant anti-tumor and anti-virus protein for injection, Saline Injection
- Keywords
- Colorectal Cancer, Novaferon
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant anti-tumor and anti-virus protein for injectionDrug
Also called Brand name: Novaferon
Recombinant anti-tumor and anti-virus protein for injection,10μg,im,twice per week for first 2 weeks, followed by 20μg, im, twice per week after 2 weeks
Recombinant anti-tumor and anti-virus protein for injectionDrug
Also called Brand name: Novaferon
Recombinant anti-tumor and anti-virus protein for injection, 10μg/1mL,im,three times per week for first 2 weeks, followed by 20μg,im, three times per week after 2 weeks.
Saline InjectionOther
Saline Injection, 1mL, im,three times per week
Recombinant anti-tumor and anti-virus protein for injectionDrug
Also called Brand name: Novaferon
Recombinant anti-tumor and anti-virus protein for injection, 10μg, im, three times per week for first week, followed by 20μg for two weeks, and followed by 30μg for a week, and followed a maintenance dose of 40μg, the frequency of administration is three times per week.
| Study group | Role | What they receive |
|---|---|---|
| The first group | Experimental | Recombinant anti-tumor and anti-virus protein for injection, twice per week Receives: Drug: Recombinant anti-tumor and anti-virus protein for injection |
| The second group | Experimental | Recombinant anti-tumor and anti-virus protein for injection, three times per week Receives: Drug: Recombinant anti-tumor and anti-virus protein for injection |
| Placebo group | Placebo comparator | Saline Injection, three times per week Receives: Other: Saline Injection |
| The third group | Experimental | High dose of recombinant anti-tumor and anti-virus protein for injection, three times per week Receives: Drug: Recombinant anti-tumor and anti-virus protein for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS is defined as the length of time from random assignment to death or to last contact.
Measured: every 8 weeks until death, the average OS is thought to be 4.5~6 months
Secondary outcomes (5)
Progression-free survival (PFS)
PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
Measured: every 6 weeks until disease progress, the estimate averge time is 2~3 months
Quality of life (QoL)
Quality of life is assessed using EORTC-C30 (the Quality of Life Questionnaire of the European Organisation for Research and Treatment of Cancer.)
Measured: every 2 weeks in first 4 weeks and every 4 weeks after 4 weeks, it will last to the treatment end.
Adverse Events(AEs)
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v3.0.
Measured: from informed consent form signed to 28 days after termination of administration.
pharmacodynamics
As the drug concentration is very low, and no commercialized kits for original drug test, So original drug will not detect. Mopterin and MxA protein (alternate index) levels in serum will be used as alternative targets for pharmacodynamic studies
Measured: The first 2 weeks during 10ug dosage were given and the following 11weeks during 20ug dosage were given
Disease Control Rate
The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria)
Measured: every 6 weeks until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2013
- Study completionMay 2014
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 Metastatic Colorectal CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Genova Biotech Company, Ltd.
- Responsible party
- Sponsor
- Investigators
- Xu jianming, M.D., Principal investigator, The Affiliated Hospital of the Chinese Academy of Military Medical Scienc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386242
- Sponsor's protocol ID
- JH-RC-001
- Status last verified
- Apr 2015
- First submitted
- 27 Jun 2011
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jia R, Wang Y, Mao XY, Li SS, Xu N, Xiong JP, Shen L, Bai L, Liu W, Liu LJ, Ge FJ, Chen YL, Lin L, Xu JM. Phase II Study of Recombinant Antitumor and Antivirus Protein Injection Compared With Placebo in Metastatic Colorectal Cancer After Failure of Standard Treatment. Oncologist. 2015 Jun;20(6):619-20. doi: 10.1634/theoncologist.2014-0439. Epub 2015 Apr 29.
PubMed 25926350
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II/III Study of Recombinant Anti-tumor and Anti-Virus Protein for Injection Compared With Placebo in Metastatic Colorectal Cancer After Failure of Second-Line and More Than Second-line Treatment
- ClinicalTrials.gov ID
- NCT01386242
- Acronym / sponsor ID
- JH-RC-001
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Colorectal Cancer, Novaferon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing Genova Biotech Company, Ltd.
- Study start
- May 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 1 Jul 2011 (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 evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection in treating patients with metastatic colorectal cancer after failure of second-line and more than second-line treatment.
Detailed description
Explanation for study design
The trial including two stages. The first is an exploration stage to decide delivery frequency and dose of study drug. It is single-blinded, subjects will be randomly divided into 4 groups with a 2:2:2:1 ratio. Study drug given twice per week or 3 times per, dose of the drug are from 20μg to 40μg. The sample size is 105, duration is 12 to 18 months. Based on preliminary efficacy and safety, the better dosage regimen will decided for the second stage.The second stage is double-blinded,subject will be randomly divided into treatment group or placebo group with 2:1 ratio and sample size is 600.
Primary purpose
To compare overall survival between study drug and placebo groups .
Secondary purpose
- Progression free survival were compared in both groups.
- Disease control rate were compared in both groups.
- Quality of life scores were compared in both groups.
- Determine the safety and tolerance of recombinant anti-tumor and anti-virus protein for injection
- Supplementary pharmacodynamics of recombinant anti-tumor and anti-virus protein for injection
Exploratory purpose Evaluate effects of recombinant anti-tumor and anti-virus protein for injection on the anti-tumor immunity, angiogenesis, apoptosis, cell proliferation, immune cells and cytokines levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| The first group | Experimental | Drug: Recombinant anti-tumor and anti-virus protein for injectionRecombinant anti-tumor and anti-virus protein for injection, twice per week |
| The second group | Experimental | Drug: Recombinant anti-tumor and anti-virus protein for injectionRecombinant anti-tumor and anti-virus protein for injection, three times per week |
| Placebo group | Placebo comparator | Other: Saline InjectionSaline Injection, three times per week |
| The third group | Experimental | Drug: Recombinant anti-tumor and anti-virus protein for injectionHigh dose of recombinant anti-tumor and anti-virus protein for injection, three times per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged above 18 years.
- ECOG performance status 0, 1 or 2.
- Pathologically confirmed metastatic colorectal cancer.
- Failure of Second-Line or Above Treatment, and irinotecan- and oxaliplatin--containing regimens (If recurrence and metastasis occurred within 6 months after discontinuation of adjuvant chemotherapy, the adjuvant chemotherapy is considered to be first-line treatment). more than 4 weeks before enrollment after discontinuation of chemotherapy.
- Minimum of 4 weeks since any local radiotherapy or surgery for the control of symptoms or severe complications(local radiotherapy for the control of bone metastases is not the limit)，and adequately recovered from toxicities of any prior therapy).
Key exclusion criteria (14 listed)
- Pregnancy or breast-feeding women or women who may be pregnant were positive drug test before administration.
- Patient of child-bearing potential(male or less than 1 year postmenopausal women) were reluctant to take contraceptive measures.
- Patient who were allergic to Interferon-α or who had interferon-α antibody.
- Patients with uncontrolled central nervous system (CNS) metastases.
- Patient with any other Malignant tumors within five years (except for a complete cure of carcinoma in situ of the cervix or basal cell cancer or squamous cell skin cancer).
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 |
|---|---|---|
| Recombinant anti-tumor and anti-virus protein for injectionAlso: Brand name: NovaferonRecombinant anti-tumor and anti-virus protein for injection,10μg,im,twice per week for first 2 weeks, followed by 20μg, im, twice per week after 2 weeks | Drug | The first group |
| Recombinant anti-tumor and anti-virus protein for injectionAlso: Brand name: NovaferonRecombinant anti-tumor and anti-virus protein for injection, 10μg/1mL,im,three times per week for first 2 weeks, followed by 20μg,im, three times per week after 2 weeks. | Drug | The second group |
| Saline InjectionSaline Injection, 1mL, im,three times per week | Other | Placebo group |
| Recombinant anti-tumor and anti-virus protein for injectionAlso: Brand name: NovaferonRecombinant anti-tumor and anti-virus protein for injection, 10μg, im, three times per week for first week, followed by 20μg for two weeks, and followed by 30μg for a week, and followed a maintenance dose of 40μg, the frequency of administration is three times per week. | Drug | The third group |
Primary outcome
Overall survival (OS)
Time frame: every 8 weeks until death, the average OS is thought to be 4.5~6 months
OS is defined as the length of time from random assignment to death or to last contact.
5 secondary outcomes
Progression-free survival (PFS)
Time frame: every 6 weeks until disease progress, the estimate averge time is 2~3 months
Quality of life (QoL)
Time frame: every 2 weeks in first 4 weeks and every 4 weeks after 4 weeks, it will last to the treatment end.
Adverse Events(AEs)
Time frame: from informed consent form signed to 28 days after termination of administration.
pharmacodynamics
Time frame: The first 2 weeks during 10ug dosage were given and the following 11weeks during 20ug dosage were given
Disease Control Rate
Time frame: every 6 weeks until disease progression
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 5 Jan 2016.
- Derived from this study: PubMed 25926350Jia R, Wang Y, Mao XY, Li SS, Xu N, Xiong JP, Shen L, Bai L, Liu W, Liu LJ, Ge FJ, Chen YL, Lin L, Xu JM. Phase II Study of Recombinant Antitumor and Antivirus Protein Injection Compared With Placebo in Metastatic Colorectal Cancer After Failure of Standard Treatment. Oncologist. 2015 Jun;20(6):619-20. doi: 10.1634/theoncologist.2014-0439. Epub 2015 Apr 29.
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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.
Xu jianming, M.D. principal investigator
The Affiliated Hospital of the Chinese Academy of Military Medical Scienc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant anti-tumor and anti-virus protein for injection and Saline Injection in people with Metastatic Colorectal Cancer, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 1 site 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 9 inclusion and 14 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 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Overall survival (OS) (time frame: every 8 weeks until death, the average OS is thought to be 4.5~6 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 NCT01386242, 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 5 Jan 2016.