Carcinoma, Non-Small-Cell LungPhase 1rSIFN-01NCT02387307
A Study of rSIFN-co in Subjects With Advanced Solid Tumors
A Phase 1 study testing rSIFN-co in people with Carcinoma, Non-Small-Cell Lung and Carcinoma, Renal Cell, run by Sichuan Huiyang Life Science and Technology Corporation at 1 site in Singapore.
Trial summary
This is a multicenter, open-label, phase I study of rSIFN-co (3 times a week via subcutaneous injection for 21 days, with 1 week of washout per cycle). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Melanoma
- What is being tested?
- rSIFN-co
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2013to Jun 2018
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a) Histologically confirmed diagnosis of advanced solid tumors that is metastatic or unresectable and for which standard therapies (according to local practice) or palliative measures do not exist or subject decides not to receive any available treatment (dose escalation cohort) OR
- Histologically or Cytologically diagnosis of Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma, Hepatocellular Carcinoma* and Colon Cancer metastatic or unrespectable and for which standard therapies (according to local practice) or palliative measures do not exist or subject decides not to receive any available treatment (dose expansion cohort) (dose expansion cohort)
- Hepatocellular Carcinoma patients may be enrolled based on radiological diagnosis instead of histological or cytological diagnosis - based on "EASL-EORTC Clinical Practice Guidelines: Management of hepatocellular carcinoma (Journal of Hepatology 56:908-943, 2012), non-invasive hepatocellular carcinoma patients should not be put under additional undue risk of liver biopsy after the diagnosis of hepatocellular carcinoma has been ascertained with clinical, laboratory and radiographic evaluation."
- Measurable disease is preferred but not mandatory for the purpose of study accrual. Evaluable disease is sufficient.
- Age > or = 21 years
- ECOG performance status < or = 2
Show all 26Show fewer
- Adequate laboratory values at the time of screening:
- (For both dose escalation and expansion)
- leukocytes ≥3,000/mcL
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/mcL
- haemoglobin ≥9.0 g/DL
- (Dose escalation only)
- total bilirubin ≤ the upper limits of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤ the upper limits of normal (ULN)
- creatinine < the upper limits of normal (ULN) OR creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal
- (Dose expansion only)
- total bilirubin ≤ 1.5 times the upper limits of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤ 2.5 times the upper limits of normal (ULN) or ≤ 4 times upper limits of normal (ULN) for patients with liver metastasis
- creatinine ≤1.5 times the upper limits of normal (ULN) OR creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine levels above 1.5 times the institutional upper limits of normal
- (For renal cell carcinoma patients)
- creatinine ≤ 1.5 times the upper limits of normal (ULN) OR creatinine clearance ≥ 40 mL/min/1.73 m2 for subjects with creatinine levels above 1.5 times the institutional upper limits of normal.
- Life expectancy > 3 months
- Agreement to be compliant to visit schedules as defined in the protocol.
- Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
- The effects of rSIFN-co on the developing human fetus are unknown. For this reason women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of r-SIFN-co administration. WOCBP must have a negative urine pregnancy test at Visit 1 (Screening).
Who cannot join
- Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to start of rSIFN-co administration or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Subjects receiving other investigational drugs within 5 times the half-life of the investigational drugs or within 4 weeks, prior to start of rSIFN-co administration.
- Subject must not have known untreated brain or meningeal metastases. CT scans are not required to rule out brain or meningeal metastases unless there is a clinical suspicion of central nervous system disease. Subjects with treated brain metastases that are radiographically or clinically stable for at least 4 weeks after therapy and have no evidence of cavitation or hemorrhage in the brain lesion(s) are eligible, provided that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 4 weeks prior to start of rSIFN-co administration).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to interferon.
- Uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, interstitial pneumonia or psychiatric illness/social situations that would limit compliance with study requirements.
- HIV-positive subjects on combination antiretroviral therapy are ineligible because of the increased risk of lethal infections when treated with immunomodulatory therapy. Appropriate studies will be undertaken in subjects receiving combination antiretroviral therapy when indicated.
- The investigator or sub-investigator considers the subject's physique as inappropriate for investigational product treatment or any other reason(s) that may render the subjects inappropriate for participation in the trial.
- Subjects who may have autoimmune disorders, decompensated liver diseases or life-threatening neurologic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Open-Label, Non-Randomized, Dose-Escalation Study of rSIFN-co in Subjects With Advanced Solid Tumors and With an Expansion Cohort at Recommended Dose (RD) in Subjects With Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma, Hepatocellular Carcinoma or Colon Cancer
This is a multicenter, open-label, phase I study of rSIFN-co (3 times a week via subcutaneous injection for 21 days, with 1 week of washout per cycle).
Read the detailed description
The Dose-Escalation Cohort will consist of the Pretreatment Phase, the Treatment Phase, the Extension Phase, Discontinuation and Follow-up. The Pretreatment Phase will include a Consent and Screening Period. The Treatment Phase will consist of the Lead in Period and first 21-day cycle of treatment during which subjects will be monitored for the development of dose-limiting toxicity (DLT) following 1 week of washout. The Extension Phase will start from the start of Cycle 2 with intra-subject dose-escalation performed until discontinuation of study treatment. Upon discontinuation of study treatment, discontinuation visit assessments should occur within 7 days of treatment discontinuation or confirmation of discontinuation criteria. End of treatment information will also be collected for all subjects who discontinue treatment after completion of cycle 1 treatment. Follow-up visit/final visit evaluations will be performed 28 (±5 days) days after the last rSIFN-co administration. The decision to undergo dose-escalation to the next dose level will be based on the safety information obtained during Cycle 1.
Dose escalation in solid tumors utilizing a "3+3" design with intra-subject dose escalation. 4 dose levels of rSIFN-co are planned for determining the RD. 3-6 subjects will be assigned to each dose level and followed up for 4 weeks after starting administration in Cycle 1. Each cohort will be started after the tolerability of that dose level has been confirmed in subjects with advanced solid tumors. For subjects starting in the lower dose cohorts, intra-subject dose escalation will be allowed till grade 3/4 toxicity is encountered or highest dose level (after safety and tolerability are confirmed) TIW is reached. In order to minimize the risk of allergic reactions, the sponsor has advised a lead-in period starting from 15μg. When the tolerability of each dose level has been confirmed by the observation of no DLT among 3 subjects, escalation to the next dose level will occur.
The Expansion Cohort will be initiated at the RD. Depending on the RD, the lead in period will occur accordingly. After the lead in period, a period from Cycle 1 to the final administration will be performed as the Treatment Phase during which subjects will undergo a standardized evaluation for the safety and efficacy of rSIFN-co at the RD. If subjects are discontinued from the study treatment, discontinuation visit assessments should occur within 7 days of last rSIFN-co administration or confirmation of discontinuation criteria. End of treatment information will also be collected for all subjects who discontinue treatment after completion of cycle 1 treatment. Follow-up evaluations will be performed 28 days (±5 days) after the last rSIFN-co administration.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Melanoma, Carcinoma, Hepatocellular, Colon Cancer
- Being tested
- rSIFN-co
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Melanoma, Carcinoma, Hepatocellular, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rSIFN-coDrug
Also called Recombinant-Compound Interferon (rSIFN-co)
rSIFN-co is a drug developed by Sichuan Huiyang Life Science and Technology Corporation for the treatment of solid tumors especially in non-small cell lung cancer and other tumor types. The study comprises of 2 stages: the dose-escalation stage and dose expansion stage.
| Study group | Role | What they receive |
|---|---|---|
| Cohort: Dose-Escalation and Expansion | Experimental | Dose-Escalation: Dose escalation in solid tumors utilizing a "3+3" design with intra-subject dose escalation. 4 dose levels of rSIFN-co are planned for determining the RD. Dose of rSIFN-co: 15, 21, 24, 27 and 30 ug.
Dose-Expansion: The Expansion Cohort will be initiated at the RD. Depending on the RD, the lead in period will occur accordingly. After the lead in period, a period from Cycle 1 to the final administration will be performed as the Treatment Phase during which subjects will undergo a standardized evaluation for the safety and efficacy of rSIFN-co at the RD. Follow-up evaluations will be performed 28 days (±5 days) after the last rSIFN-co administration. Receives: Drug: rSIFN-co |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events of rSIFN-co of recombinant interferon-α administered in solid Tumor
Safety and tolerability will be determined after each cycle of treatment with SIFN-co of recombinant interferon-α, to patients via subcutaneous injection for 21 days (up to 6 cycles)
Measured: Up to 12 weeks after the last treatment
Recommended dose (RD) of rSIFN-co
3+3 design for determination of RD. 4 doses (21µg, 24µg, 27µg and 30µg) are planned for determination of RD, dose escalation will be allowed till grade 3/4 toxicity is encountered in 2 or more of the 3 or 6 subjects in first cycle of treatment cycle
Measured: Cycle 1 of treatment
Secondary outcomes (6)
Antitumor efficacy (Disease Control Rate), i.e. the percentage of patients, on the RD of rSIFN-co
Antitumor response will be evaluated based on RECIST and irRC guidelines
Measured: Up to 28 days after the last treatment
Objective response rate (ORR), i.e. the percentage of patients, on rSIFN-co
Subjects will be re-evaluated at end of cycle 1, completion of every even cycle treatment, Discontinuation Visit and Follow-up Visit. Confirmatory scans will be obtained within 4 to 8 weeks following initial documentation of an objective response. Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009].
Antitumor response based on total measurable tumor burden irRC, index and measurable new lesions are taken into account. Each subsequent tumor assessment, the SPD of the index lesions and of new, measurable lesions (≥5 × 5 mm; up to 5 new lesions per organ: 5 new cutaneous lesions and 10 visceral lesions) are added together to provide the total tumor burden, the objective is to determine response rate (ORR), progression-free survival (PFS),and time to progression (TTP) status on rSIFN-co.
Measured: Up to 28 days after the last treatment
Progression-free survival (PFS) time (days) on rSIFN-co
Subjects will be re-evaluated at end of cycle 1, completion of every even cycle treatment, Discontinuation Visit and Follow-up Visit. Confirmatory scans will be obtained within 4 to 8 weeks following initial documentation of an objective response. Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009].
Antitumor response based on total measurable tumor burden irRC, index and measurable new lesions are taken into account. Each subsequent tumor assessment, the SPD of the index lesions and of new, measurable lesions (≥5 × 5 mm; up to 5 new lesions per organ: 5 new cutaneous lesions and 10 visceral lesions) are added together to provide the total tumor burden, the objective is to determine response rate (ORR), progression-free survival (PFS),and time to progression (TTP) status on rSIFN-co.
Measured: Up to 28 days after the last treatment
Time to progression (TTP) status (days) on rSIFN-co
Subjects will be re-evaluated at end of cycle 1, completion of every even cycle treatment, Discontinuation Visit and Follow-up Visit. Confirmatory scans will be obtained within 4 to 8 weeks following initial documentation of an objective response. Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009].
Antitumor response based on total measurable tumor burden irRC, index and measurable new lesions are taken into account. Each subsequent tumor assessment, the SPD of the index lesions and of new, measurable lesions (≥5 × 5 mm; up to 5 new lesions per organ: 5 new cutaneous lesions and 10 visceral lesions) are added together to provide the total tumor burden, the objective is to determine response rate (ORR), progression-free survival (PFS),and time to progression (TTP) status on rSIFN-co.
Measured: Up to 28 days after the last treatment
FDG-PET response (lesion size) before and after administration of rSIFN-co
CT and SUV values used to determine lesion size will be evaluated and studied to understand the change of CT value\& SUV value before and after treatment.
Measured: Up to 28 days after the last treatment
FDG-PET response (lesion volume) before and after administration of rSIFN-co
CT and SUV values used to determine lesion volume will be evaluated and studied to understand the change of CT value\& SUV value before and after treatment.
Measured: Up to 28 days after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startJul 2013
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Huiyang Life Science and Technology Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Wai Meng TAI, Principal investigator, National Cancer Center Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387307
- Sponsor's protocol ID
- rSIFN-01
- Acronym
- rSIFN-01
- Status last verified
- Sep 2019
- First submitted
- 6 Feb 2015
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label, Non-Randomized, Dose-Escalation Study of rSIFN-co in Subjects With Advanced Solid Tumors and With an Expansion Cohort at Recommended Dose (RD) in Subjects With Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma, Hepatocellular Carcinoma or Colon Cancer
- ClinicalTrials.gov ID
- NCT02387307
- Acronym / sponsor ID
- rSIFN-01 / rSIFN-01
- Conditions
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Melanoma, Carcinoma, Hepatocellular, Colon Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Sichuan Huiyang Life Science and Technology CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2013 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 13 Mar 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.
This is a multicenter, open-label, phase I study of rSIFN-co (3 times a week via subcutaneous injection for 21 days, with 1 week of washout per cycle).
Detailed description
The Dose-Escalation Cohort will consist of the Pretreatment Phase, the Treatment Phase, the Extension Phase, Discontinuation and Follow-up. The Pretreatment Phase will include a Consent and Screening Period. The Treatment Phase will consist of the Lead in Period and first 21-day cycle of treatment during which subjects will be monitored for the development of dose-limiting toxicity (DLT) following 1 week of washout. The Extension Phase will start from the start of Cycle 2 with intra-subject dose-escalation performed until discontinuation of study treatment. Upon discontinuation of study treatment, discontinuation visit assessments should occur within 7 days of treatment discontinuation or confirmation of discontinuation criteria. End of treatment information will also be collected for all subjects who discontinue treatment after completion of cycle 1 treatment. Follow-up visit/final visit evaluations will be performed 28 (±5 days) days after the last rSIFN-co administration. The decision to undergo dose-escalation to the next dose level will be based on the safety information obtained during Cycle 1.
Dose escalation in solid tumors utilizing a "3+3" design with intra-subject dose escalation. 4 dose levels of rSIFN-co are planned for determining the RD. 3-6 subjects will be assigned to each dose level and followed up for 4 weeks after starting administration in Cycle 1. Each cohort will be started after the tolerability of that dose level has been confirmed in subjects with advanced solid tumors. For subjects starting in the lower dose cohorts, intra-subject dose escalation will be allowed till grade 3/4 toxicity is encountered or highest dose level (after safety and tolerability are confirmed) TIW is reached. In order to minimize the risk of allergic reactions, the sponsor has advised a lead-in period starting from 15μg. When the tolerability of each dose level has been confirmed by the observation of no DLT among 3 subjects, escalation to the next dose level will occur.
The Expansion Cohort will be initiated at the RD. Depending on the RD, the lead in period will occur accordingly. After the lead in period, a period from Cycle 1 to the final administration will be performed as the Treatment Phase during which subjects will undergo a standardized evaluation for the safety and efficacy of rSIFN-co at the RD. If subjects are discontinued from the study treatment, discontinuation visit assessments should occur within 7 days of last rSIFN-co administration or confirmation of discontinuation criteria. End of treatment information will also be collected for all subjects who discontinue treatment after completion of cycle 1 treatment. Follow-up evaluations will be performed 28 days (±5 days) after the last rSIFN-co administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort: Dose-Escalation and Expansion | Experimental | Drug: rSIFN-coDose-Escalation: Dose escalation in solid tumors utilizing a "3+3" design with intra-subject dose escalation. 4 dose levels of rSIFN-co are planned for determining the RD. Dose of rSIFN-co: 15, 21, 24, 27 and 30 ug. Dose-Expansion: The Expansion Cohort will be initiated at the RD. Depending on the RD, the lead in period will occur accordingly. After the lead in period, a period from Cycle 1 to the final administration will be performed as the Treatment Phase during which subjects will undergo a standardized evaluation for the safety and efficacy of rSIFN-co at the RD. Follow-up evaluations will be performed 28 days (±5 days) after the last rSIFN-co administration. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- a) Histologically confirmed diagnosis of advanced solid tumors that is metastatic or unresectable and for which standard therapies (according to local practice) or palliative measures do not exist or subject decides not to receive any available treatment (dose escalation cohort) OR
- Measurable disease is preferred but not mandatory for the purpose of study accrual. Evaluable disease is sufficient.
- Age > or = 21 years
- ECOG performance status < or = 2
- Adequate laboratory values at the time of screening:
Key exclusion criteria (8 listed)
- Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to start of rSIFN-co administration or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Subjects receiving other investigational drugs within 5 times the half-life of the investigational drugs or within 4 weeks, prior to start of rSIFN-co administration.
- Subject must not have known untreated brain or meningeal metastases. CT scans are not required to rule out brain or meningeal metastases unless there is a clinical suspicion of central nervous system disease. Subjects with treated brain metastases that are radiographically or clinically stable for at least 4 weeks after therapy and have no evidence of cavitation or hemorrhage in the brain lesion(s) are eligible, provided that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 4 weeks prior to start of rSIFN-co administration).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to interferon.
- Uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, interstitial pneumonia or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| rSIFN-coAlso: Recombinant-Compound Interferon (rSIFN-co)rSIFN-co is a drug developed by Sichuan Huiyang Life Science and Technology Corporation for the treatment of solid tumors especially in non-small cell lung cancer and other tumor types. The study comprises of 2 stages: the dose-escalation stage and dose expansion stage. | Drug | Cohort: Dose-Escalation and Expansion |
Primary outcome
Adverse Events of rSIFN-co of recombinant interferon-α administered in solid Tumor
Time frame: Up to 12 weeks after the last treatment
Safety and tolerability will be determined after each cycle of treatment with SIFN-co of recombinant interferon-α, to patients via subcutaneous injection for 21 days (up to 6 cycles)
Recommended dose (RD) of rSIFN-co
Time frame: Cycle 1 of treatment
3+3 design for determination of RD. 4 doses (21µg, 24µg, 27µg and 30µg) are planned for determination of RD, dose escalation will be allowed till grade 3/4 toxicity is encountered in 2 or more of the 3 or 6 subjects in first cycle of treatment cycle
6 secondary outcomes
Antitumor efficacy (Disease Control Rate), i.e. the percentage of patients, on the RD of rSIFN-co
Time frame: Up to 28 days after the last treatment
Objective response rate (ORR), i.e. the percentage of patients, on rSIFN-co
Time frame: Up to 28 days after the last treatment
Progression-free survival (PFS) time (days) on rSIFN-co
Time frame: Up to 28 days after the last treatment
Time to progression (TTP) status (days) on rSIFN-co
Time frame: Up to 28 days after the last treatment
FDG-PET response (lesion size) before and after administration of rSIFN-co
Time frame: Up to 28 days after the last treatment
FDG-PET response (lesion volume) before and after administration of rSIFN-co
Time frame: Up to 28 days after the last treatment
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 27 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
David Wai Meng TAI principal investigator
National Cancer Center Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rSIFN-co in people with Carcinoma, Non-Small-Cell Lung and Carcinoma, Renal Cell, run by Sichuan Huiyang Life Science and Technology Corporation at 1 site in Singapore.
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 26 inclusion and 8 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 27 Sep 2019. 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 Singapore. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse Events of rSIFN-co of recombinant interferon-α administered in solid Tumor (time frame: Up to 12 weeks after the last treatment). The study lists 2 primary outcomes in all. 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 27 Sep 2019.