Non-small Cell Lung CancerPhase 1NSCLCNCT03607188
Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer
A Phase 1 study testing Alkotinib in people with Non-small Cell Lung Cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
To explore the DLT of ZG0418 for Patients with Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib, and to determine the MTD or the R2PD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Alkotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2018to 17 Oct 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2.
- Life expectancy of at least 12 weeks.
- Ability to swallow and retain oral medication.
- Adequate organ system function, defined as follows:
- Absolute neutrophil count (ANC) ≥1.5 x 10^9/L
Show all 14Show fewer
- Platelets ≥75 x 10^9/L
- Hemoglobin ≥9 g/dL (≥90 g/L) Note that transfusions are allowed to meet the required hemoglobin level
- Total bilirubin ≤1.5 times the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
- ≤2.5 x ULN if no liver involvement or ≤5 x ULN with liver involvement.
- Creatinine 1.5 x ULN.
- Brain metastases allowed if asymptomatic at study baseline.
- Patients must have measurable disease per RECIST v. 1.1.
Who cannot join
- chemotherapy, radiation therapy, immunotherapy within 4 weeks.
- Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
- uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Tolerance, Safety and Efficacy Study of Alkotinib in Patients With Advanced ALK Positive /ROS1 Positive NSCLC and Previously Treated With Chemotherapy or Crizotinib
To explore the DLT of ZG0418 for Patients with Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib, and to determine the MTD or the R2PD.
Read the detailed description
The study is a randomized, double-blind phase 1 trial including 2 sequential parts: single ascending dose(SAD) part,multiple ascending dose(MAD) part. SAD and MAD are dose-escalated tolerant study designing. The aims of the study as below:
- Evaluating the safety and tolerance of ZG0418 in ALK+ NSCLC.
- Evaluating the fasting pharmacokinetic parameters of ZG0418 in ALK+ NSCLCJaktinib.
- Evaluating the postprandial pharmacokinetic parameters of ZG0418 in ALK+ NSCLC.
- Analysis the metabolites of ZG0418
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Alkotinib
- 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.
AlkotinibDrug
Also called ZG0418
Alkotinib 200mg QD、 Alkotinib 300mg QD、 Alkotinib 400mg QD、 Alkotinib 500mg QD、 Alkotinib 600mg QD
| Study group | Role | What they receive |
|---|---|---|
| ZG0418 200mg QD | Experimental | ZG0418 200mg/day,oral Receives: Drug: Alkotinib |
| ZG0418 300mg QD | Experimental | ZG0418 300mg/day,oral Receives: Drug: Alkotinib |
| ZG0418 400mg QD | Experimental | ZG0418 400mg/day,oral Receives: Drug: Alkotinib |
| ZG0418 500mg QD | Experimental | ZG0418 500mg/day,oral Receives: Drug: Alkotinib |
| ZG0418 600mg QD | Experimental | ZG0418 600mg/day,oral Receives: Drug: Alkotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Evaluating Dose-Limiting Toxicities (DLTs) from the individuals taking orally dose-escalated Alkotinib
Measured: Day1 to Day25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start18 Oct 2018
- Primary completion17 Oct 2022
- Study completion17 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, Doctor, Principal investigator, Shanghai Eastern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607188
- Sponsor's protocol ID
- ZGALK001
- Acronym
- NSCLC
- Status last verified
- Mar 2024
- First submitted
- 23 Jul 2018
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Tolerance, Safety and Efficacy Study of Alkotinib in Patients With Advanced ALK Positive /ROS1 Positive NSCLC and Previously Treated With Chemotherapy or Crizotinib
- ClinicalTrials.gov ID
- NCT03607188
- Acronym / sponsor ID
- NSCLC / ZGALK001
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 31 Jul 2018 (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.
To explore the DLT of ZG0418 for Patients with Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib, and to determine the MTD or the R2PD.
Detailed description
The study is a randomized, double-blind phase 1 trial including 2 sequential parts: single ascending dose(SAD) part,multiple ascending dose(MAD) part. SAD and MAD are dose-escalated tolerant study designing. The aims of the study as below:
- Evaluating the safety and tolerance of ZG0418 in ALK+ NSCLC.
- Evaluating the fasting pharmacokinetic parameters of ZG0418 in ALK+ NSCLCJaktinib.
- Evaluating the postprandial pharmacokinetic parameters of ZG0418 in ALK+ NSCLC.
- Analysis the metabolites of ZG0418
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ZG0418 200mg QD | Experimental | Drug: AlkotinibZG0418 200mg/day,oral |
| ZG0418 300mg QD | Experimental | Drug: AlkotinibZG0418 300mg/day,oral |
| ZG0418 400mg QD | Experimental | Drug: AlkotinibZG0418 400mg/day,oral |
| ZG0418 500mg QD | Experimental | Drug: AlkotinibZG0418 500mg/day,oral |
| ZG0418 600mg QD | Experimental | Drug: AlkotinibZG0418 600mg/day,oral |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2.
- Life expectancy of at least 12 weeks.
- Ability to swallow and retain oral medication.
- Adequate organ system function, defined as follows:
Key exclusion criteria (3 listed)
- chemotherapy, radiation therapy, immunotherapy within 4 weeks.
- Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
- uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion.
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 |
|---|---|---|
| AlkotinibAlso: ZG0418Alkotinib 200mg QD、 Alkotinib 300mg QD、 Alkotinib 400mg QD、 Alkotinib 500mg QD、 Alkotinib 600mg QD | Drug | ZG0418 200mg QD, ZG0418 300mg QD, ZG0418 400mg QD, ZG0418 500mg QD, ZG0418 600mg QD |
Primary outcome
MTD
Time frame: Day1 to Day25
Evaluating Dose-Limiting Toxicities (DLTs) from the individuals taking orally dose-escalated Alkotinib
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 6 Mar 2024.
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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.
Jin Li, Doctor principal investigator
Shanghai Eastern Hospital
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 Alkotinib in people with Non-small Cell Lung Cancer, run by Suzhou Zelgen Biopharmaceuticals 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 14 inclusion and 3 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 6 Mar 2024. 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?
MTD (time frame: Day1 to Day25). 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 6 Mar 2024.