Carcinoma，Non-Small-Cell LungPhase 1NCT03053219
Preliminary Evaluation of Safety and Efficacy by [14C] AC0010 Trail and Subsequent AC0010 Treatment
A Phase 1 study testing AC0010 in people with Carcinoma，Non-Small-Cell Lung, run by Hangzhou ACEA Pharmaceutical Research Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate safety and efficacy of male Patients With Advanced NSCLC who participant in [14C] AC0010 ADME. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Carcinoma，Non-Small-Cell Lung
- What is being tested?
- AC0010
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Dec 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed and dated informed consent
- histologically or cytologically confirmed diagnosis of local advanced or recurrent NSCLC
- failed to the treatment of EGFR-TKI and harbored T790M mutation
- male, Age 18~ 65, have a body mass index (BMI)>19 kg/m2
- Eastern Cooperative Oncology Group performance status(ECOG PS):0-1,Life expectancy of more than 3 months
- main organs function is normal, laboratory values as listed below: blood test without blood transfusion within 14 days
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- Haemoglobin >100 g/L
- Absolute neutrophil count ≥2.0x10^9/L or WBC ≥3.5 x10^9/L
- Platelet count ≥ 80x10^9/L
- Total bilirubin ≤1.5xULN
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN)
- Serum creatinine ≤1.5xULN or creatinine clearance ratio ≥60 mL/ min
- Any prior treatment (chemotherapy, radiotherapy or surgery) must be completed over 4 weeks(target therapy over 2 weeks) from the screening; Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (CTCAE v 4.03)
- International normalized ratio (INR) ≤ 1.5
- Patients and their partners should be willing to use methods of contraception or total abstinence from start of dosing until 6 months after discontinuing of study treatment
- Patients must withdraw from previous study of [14C] AC0010
Who cannot join
- Prior treated with AC0010 or allergic to drug or its formulation ingredients
- Patients receiving other anti-tumor therapy
- Impairment of GI disease, renal disorders or liver disease that may significantly alter the absorption and metabolic of AC0010 (e.g., Unable to swallow, liver, kidney or gastrointestinal partial resection, chronic diarrhea and intestinal obstruction)
- HCVAb positive, active hepatitis B (excluding HBV carriers), Hepatitis virus markers positive and receiving anti-virus drugs
- Meningeal metastasis; brain metastasis with whole brain radiotherapy; prior received hormones or mannitol for the brain metastasis
- Previous EGFR-TKI treatment related Interstitial lung disease history
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- Known human immunodeficiency virus infection (HIV), other acquired or congenital immunodeficiency disease, or a history of organ transplantation
- Any severe and / or uncontrolled active infections
- Patients receiving concomitant immunosuppressive agents or high-dose corticosteroids
- Any severe and / or uncontrolled medical conditions
- Patients being treated with drugs recognized as being inhibitors or inducers of the liver isoenzyme in the last 4 weeks prior to registration in the current study
- Within 3 days prior to the treatment taking of dragon fruit, pomelo, grapefruit, orange, mango and other fruit may affect drug metabolizing enzymes or juice
- Major surgery, incisional biopsy or traumatic injuries;
- Within 4 weeks prior to the screening patients with bleeding ≥ grade 3, non-healing wound, sever ulcer or bone fracture
- Patients received high dose irradiation treatment or other 14C-labeled drug within 1 year
- Known a history of alcoholism or drug abuse
- Investigator judgment that patient is unsuitable to participate in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Non-Randomized, Single-Center Study to Preliminary Evaluation of Safety and Efficacy of Patients Who Participant in [14C] AC0010 Trail and Subsequent Receiving AC0010 Treatment
The purpose of this study is to evaluate safety and efficacy of male Patients With Advanced NSCLC who participant in [14C] AC0010 ADME.
Read the detailed description
The purpose of this study is to evaluate safety and efficacy of male Patients With Advanced NSCLC who participant in [14C] AC0010 ADME (absorption, distribution, metabolism and excretion) trial and subsequent receiving AC0010 treatment.
- Conditions
- Carcinoma，Non-Small-Cell Lung
- Being tested
- AC0010
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC0010Drug
Also called AC0010MA
Oral dose of 300mg bid,the two doses are advised to be administered at an interval of 12 hours
| Study group | Role | What they receive |
|---|---|---|
| AC0010 | Experimental | each participant will be given AC0010 300mg bid Receives: Drug: AC0010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
To assess the overall Objective Response Rate(ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced NSCLC.
Measured: RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months
Secondary outcomes (3)
Progression Free Survival
To assess the Progression Free Survival(PFS) of AC0010 in EGFR T790M mutation-positive patients with advanced NSCLC.
Measured: RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months
Disease control rate
To assess the Disease control rate(DCR) of AC0010 in EGFR T790M mutation-positive patients with advanced NSCLC.
Measured: RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months
Number of adverse events (AE) experienced by patients to assess safety
To assess the safety of AC0010 in EGFR T790M mutation-positive patients with advanced NSCLC.
Measured: From date of Signed informed consent forms until 30 days after disease progression, intolerable toxicity or withdrawal from study, approximately up to 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startNov 2016
- Primary completionJul 2018
- Study completionDec 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou ACEA Pharmaceutical Research Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lingxiang Liu, Doctor, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053219
- Sponsor's protocol ID
- AC201606AVTN07
- Status last verified
- Jan 2019
- First submitted
- 19 Dec 2016
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-Randomized, Single-Center Study to Preliminary Evaluation of Safety and Efficacy of Patients Who Participant in [14C] AC0010 Trail and Subsequent Receiving AC0010 Treatment
- ClinicalTrials.gov ID
- NCT03053219
- Acronym / sponsor ID
- AC201606AVTN07
- Conditions
- Carcinoma，Non-Small-Cell Lung
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hangzhou ACEA Pharmaceutical Research Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 15 Feb 2017 (actual)
- 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 safety and efficacy of male Patients With Advanced NSCLC who participant in [14C] AC0010 ADME.
Detailed description
The purpose of this study is to evaluate safety and efficacy of male Patients With Advanced NSCLC who participant in [14C] AC0010 ADME (absorption, distribution, metabolism and excretion) trial and subsequent receiving AC0010 treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AC0010 | Experimental | Drug: AC0010each participant will be given AC0010 300mg bid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- signed and dated informed consent
- histologically or cytologically confirmed diagnosis of local advanced or recurrent NSCLC
- failed to the treatment of EGFR-TKI and harbored T790M mutation
- male, Age 18~ 65, have a body mass index (BMI)>19 kg/m2
- Eastern Cooperative Oncology Group performance status(ECOG PS):0-1,Life expectancy of more than 3 months
Key exclusion criteria (17 listed)
- Prior treated with AC0010 or allergic to drug or its formulation ingredients
- Patients receiving other anti-tumor therapy
- Impairment of GI disease, renal disorders or liver disease that may significantly alter the absorption and metabolic of AC0010 (e.g., Unable to swallow, liver, kidney or gastrointestinal partial resection, chronic diarrhea and intestinal obstruction)
- HCVAb positive, active hepatitis B (excluding HBV carriers), Hepatitis virus markers positive and receiving anti-virus drugs
- Meningeal metastasis; brain metastasis with whole brain radiotherapy; prior received hormones or mannitol for the brain metastasis
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 |
|---|---|---|
| AC0010Also: AC0010MAOral dose of 300mg bid,the two doses are advised to be administered at an interval of 12 hours | Drug | AC0010 |
Primary outcome
Objective Response Rate
Time frame: RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months
To assess the overall Objective Response Rate(ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced NSCLC.
3 secondary outcomes
Progression Free Survival
Time frame: RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months
Disease control rate
Time frame: RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months
Number of adverse events (AE) experienced by patients to assess safety
Time frame: From date of Signed informed consent forms until 30 days after disease progression, intolerable toxicity or withdrawal from study, approximately up to 18 months)
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 1 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Lingxiang Liu, Doctor principal investigator
The First Affiliated Hospital with Nanjing Medical University
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 AC0010 in people with Carcinoma，Non-Small-Cell Lung, run by Hangzhou ACEA Pharmaceutical Research Co., Ltd. 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 16 inclusion and 17 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 1 Feb 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 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 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?
Objective Response Rate (time frame: RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 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 1 Feb 2019.