Advanced CancerPhase 1NCT02779699
A Study of AL2846 on Tolerance and Pharmacokinetics
A Phase 1 study testing AL2846 in people with Advanced Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
A study of AL2846,a C-met/Hepatocyte growth factor tyrosine kinase inhibitor,in patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- AL2846
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Oct 2020
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological documentation of Advanced solid tumors（especially Hepatocellular Carcinoma and Lung Cancer ）,at least one measurable lesion (by RECIST1.1)
- Lack of the standard treatment or treatment failure
- 18-65 years,ECOG PS:0-1,Life expectancy of more than 3 months
- 30 Days or more from the last cytotoxic therapy
- Main organs function is normal
- Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
- Patients should participate in the study voluntarily and sign informed consent
Who cannot join
- Patients suffering from other malignancies currently or ever, except for cured cervical carcinoma in situ, non-melanoma skin cancers
- Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
- Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now
- Blood pressure unable to be controlled ideally by one drug(systolic pressure≥140 mmHg，diastolic pressure≥90 mmHg); Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including male QTc≥450ms,female QTc≥470ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification)
- Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed
- Patients with non-healing wounds or fractures
Show all 9Show fewer
- Patients with drug abuse history and unable to get rid of or Patients with mental disorders
- History of immunodeficiency
- Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
Trial locations and contacts
1 site in 1 country.
Yuankai Shi, doctor contact
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Yuankai Shi, doctor
About this study
Official title: Phase I Study of Tolerance and Pharmacokinetics of AL2846 in Patients With Advanced Cancer
A study of AL2846,a C-met/Hepatocyte growth factor tyrosine kinase inhibitor,in patients with advanced cancer.
Read the detailed description
To study the pharmacokinetic characteristics of AL2846 in the human body; To recommend a reasonable dose and indication for subsequent research.
- Conditions
- Advanced Cancer
- Being tested
- AL2846
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL2846Drug
AL2846 p.o. qd
| Study group | Role | What they receive |
|---|---|---|
| AL2846 | Experimental | AL2846 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Drug: AL2846 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The type of dose-limiting toxicity(ies) (DLT[s]) of AL2846
Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug ：II °or above of kidney damage，III °or above of non-hematological toxicity,IV°hematological toxicity ,Neutropenia associated with fever.
Measured: For 4 weeks for DLTs
Pharmacokinetics of AL2846 (in plasma)
In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H4/H8/H11/H24/H34/H48/H58/H72/H96/H120/H168 (H means Hour). In the study of multiple-dose, full PK profiles will be obtained at D0/D1/D4/D7/D10/D13/D15/D18/D21/D24/D28 (D means Day).
Measured: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
The maximum tolerated dose (MTD) of AL2846
The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment
Measured: 48 weeks
Secondary outcomes (1)
Objective Response Rate (ORR)
Percentage of participants with OR based assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: each 56 days up to intolerance the toxicity or PD (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779699
- Sponsor's protocol ID
- AL2846-I-0001
- Status last verified
- May 2019
- First submitted
- 16 May 2016
- Last updated
- 21 May 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 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Tolerance and Pharmacokinetics of AL2846 in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT02779699
- Acronym / sponsor ID
- AL2846-I-0001
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 20 May 2016 (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.
A study of AL2846,a C-met/Hepatocyte growth factor tyrosine kinase inhibitor,in patients with advanced cancer.
Detailed description
To study the pharmacokinetic characteristics of AL2846 in the human body; To recommend a reasonable dose and indication for subsequent research.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AL2846 | Experimental | Drug: AL2846AL2846 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological documentation of Advanced solid tumors（especially Hepatocellular Carcinoma and Lung Cancer ）,at least one measurable lesion (by RECIST1.1)
- Lack of the standard treatment or treatment failure
- 18-65 years,ECOG PS:0-1,Life expectancy of more than 3 months
- 30 Days or more from the last cytotoxic therapy
- Main organs function is normal
Key exclusion criteria (9 listed)
- Patients suffering from other malignancies currently or ever, except for cured cervical carcinoma in situ, non-melanoma skin cancers
- Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
- Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now
- Blood pressure unable to be controlled ideally by one drug(systolic pressure≥140 mmHg，diastolic pressure≥90 mmHg); Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including male QTc≥450ms,female QTc≥470ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification)
- Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed
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 |
|---|---|---|
| AL2846AL2846 p.o. qd | Drug | AL2846 |
Primary outcome
The type of dose-limiting toxicity(ies) (DLT[s]) of AL2846
Time frame: For 4 weeks for DLTs
Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug ：II °or above of kidney damage，III °or above of non-hematological toxicity,IV°hematological toxicity ,Neutropenia associated with fever.
Pharmacokinetics of AL2846 (in plasma)
Time frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H4/H8/H11/H24/H34/H48/H58/H72/H96/H120/H168 (H means Hour). In the study of multiple-dose, full PK profiles will be obtained at D0/D1/D4/D7/D10/D13/D15/D18/D21/D24/D28 (D means Day).
The maximum tolerated dose (MTD) of AL2846
Time frame: 48 weeks
The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment
1 secondary outcome
Objective Response Rate (ORR)
Time frame: each 56 days up to intolerance the toxicity or PD (up to 24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Advanced Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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.
Yuankai Shi, doctor contact
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 AL2846 in people with Advanced Cancer, run by Chia Tai Tianqing Pharmaceutical Group 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 21 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuankai Shi, doctor (syuankaipumc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The type of dose-limiting toxicity(ies) (DLT[s]) of AL2846 (time frame: For 4 weeks for DLTs). The study lists 3 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 21 May 2019.