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Clinical Study of AL2846 Capsules in the Treatment of Advanced Lung Tumor and Advanced Ovarian Cancer

Primary Purpose

Advanced Lung Cancer, Ovarian Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
AL2846 capsule
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects with advanced lung cancer or ovarian cancer confirmed by histopathology or cytology; Age: 18~75 years old (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) score: 0-1; At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1; Normal function of main organs The serum Human Chorionic Gonadotropin (HCG) test of female patients of childbearing age must be negative within 7 days before study enrollment and must be non-lactating; The patient should agree to use contraception during the study period and within 6 months after the end of the study period;Male subjects should agree to use contraception during the study period and for 6 months after the study period ends; The patient voluntarily joined the study and signed the informed consent form, with good compliance. Exclusion Criteria: Combined with the following diseases or medical history: Other malignant tumors have occurred or are present at the same time within<3 years before the first administration. Inability to tolerate multiple factors affecting oral medication due to any reason; Common Terminology Criteria for Adverse Events (CTCAE) 5.0 > grade 1 therapeutic toxicity caused by any previous treatment that has not been completely relieved, excluding hair loss; Major surgical treatment or obvious traumatic injury was received within 4 weeks before the first administration; The presence of unhealed wounds, fractures, gastric and duodenal active ulcers, persistent positive fecal occult-blood, ulcerative colitis, or other conditions determined by investigators that may cause gastrointestinal bleeding or perforation; Arteriovenous thrombosis, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc., occurred within 6 months before the first medication; Those who have a history of psychotropic drug abuse and cannot abstain or have mental disorders; Subjects with any severe and/or uncontrollable disease; Tumor related symptoms and treatment: Had received chemotherapy, radiation, or other anticancer therapy within 4 weeks prior to first dose; Within 2 weeks before the first dose, received Chinese Traditional drugs with anti-tumor indications specified in theNational Medical Products Administration (NMPA) approved drug instructions Previously treated with anti-angiogenic drugs such as Cabozantinib, Anlotinib, Endostar and Bevacizumab; Imaging Computed Tomography (CT)or Magnetic Resonance Imaging (MRI) shows that the tumor has invaded important blood vessels or the investigator determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study; There is a history of interstitial lung disease, severe impairment of lung function, severe pulmonary fibrosis, severe radiation pneumonia, drug-induced lung disease, and evidence of severe active lung inflammation indicated by chest CT examination during screening; There are uncontrolled pleural effusion, ascites and moderate or above pericardial effusion requiring repeated drainage; Patients with brain metastases accompanied by symptoms or symptoms controlled for less than 2 weeks; Patients who have participated in and used other antitumor investigational drugs within 4 weeks before the first dose; Central squamous cell carcinoma (lung cancer subjects) with great risk of hemoptysis; Patients with concomitant diseases that, in the opinion of the investigators, seriously endanger the safety of the patients or affect the completion of the study, or who are not suitable for inclusion for other reasons.

Sites / Locations

  • Hunan Cancer HospitalRecruiting
  • The Third Xiangya Hospital of Central South UniversityRecruiting
  • Northern Jiangsu People's HospitalRecruiting
  • Shanghai Pulmonary HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AL2846 capsule

Arm Description

orally administer AL2846 capsules monotherapy, 28 days as a treatment cycle.

Outcomes

Primary Outcome Measures

Objective remission rate (ORR)
ORR is defined as the percentage of subjects in complete remission (CR), partial remission (PR), and disease stability (SD).
Progression free survival (PFS)
PFS is defined as the time from randomization to the first recorded progressive disease (PD) or death from any cause.

Secondary Outcome Measures

Disease control rate (DCR)
Percentage of subjects achieving complete response (CR) and partial response (PR).
Duration of remission (DOR)
The time from the first evaluation as CR or PR to the first evaluation as PD or death from any cause.
Overall survival (OS)
Time from the first administration to death from any cause.
Adverse events (AEs) rate
Occurrence of all adverse events, regardless of whether there was a causal relation with the studied drug.
Peak concentration (Cmax)
Maximum plasma drug concentration
Time to peak concentration (Tmax)
Time to reach peak plasma drug concentration after dose.
Clearance half life (t1/2)
The time it takes for the drug concentration in the body to drop by half
Area under blood concentration-time curve (AUC)
After administration, the area under the curve is obtained using the blood drug concentration as the ordinate and time as the abscissa.

Full Information

First Posted
April 4, 2023
Last Updated
April 4, 2023
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05815862
Brief Title
Clinical Study of AL2846 Capsules in the Treatment of Advanced Lung Tumor and Advanced Ovarian Cancer
Official Title
A Multi-cohort, Randomized, Open, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AL2846 Capsules in Treated Subjects With Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a multi-cohort, randomized, open, multicenter Phase II study to evaluate the efficacy and safety of AL2846 capsules in patients with advanced lung cancer and ovarian cancer. Objective response rate (ORR) and progression-free survival (PFS) are the primary endpoints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Lung Cancer, Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AL2846 capsule
Arm Type
Experimental
Arm Description
orally administer AL2846 capsules monotherapy, 28 days as a treatment cycle.
Intervention Type
Drug
Intervention Name(s)
AL2846 capsule
Intervention Description
AL2846 is a multi-target tyrosine kinase inhibitor.
Primary Outcome Measure Information:
Title
Objective remission rate (ORR)
Description
ORR is defined as the percentage of subjects in complete remission (CR), partial remission (PR), and disease stability (SD).
Time Frame
From baseline up to 12 months.
Title
Progression free survival (PFS)
Description
PFS is defined as the time from randomization to the first recorded progressive disease (PD) or death from any cause.
Time Frame
From baseline up to 12 months.
Secondary Outcome Measure Information:
Title
Disease control rate (DCR)
Description
Percentage of subjects achieving complete response (CR) and partial response (PR).
Time Frame
From baseline up to 12 months.
Title
Duration of remission (DOR)
Description
The time from the first evaluation as CR or PR to the first evaluation as PD or death from any cause.
Time Frame
From baseline up to 12 months.
Title
Overall survival (OS)
Description
Time from the first administration to death from any cause.
Time Frame
From baseline to the death events, assessed up to 3 years.
Title
Adverse events (AEs) rate
Description
Occurrence of all adverse events, regardless of whether there was a causal relation with the studied drug.
Time Frame
From baseline to 28 days after the last dose or initiation of a new antineoplastic therapy (whichever comes first).
Title
Peak concentration (Cmax)
Description
Maximum plasma drug concentration
Time Frame
Pre-dose, 30 minutes, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours after dose on Day 1 and Day 28 of Cycle 1. Pre-dose on Day 7, Day 14 and 21 of cycle 1. Each cycle is 28 days.
Title
Time to peak concentration (Tmax)
Description
Time to reach peak plasma drug concentration after dose.
Time Frame
Pre-dose, 30 minutes, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours after dose on Day 1 and Day 28 of Cycle 1. Pre-dose on Day 7, Day 14 and 21 of cycle 1. Each cycle is 28 days.
Title
Clearance half life (t1/2)
Description
The time it takes for the drug concentration in the body to drop by half
Time Frame
Pre-dose, 30 minutes, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours after dose on Day 1 and Day 28 of Cycle 1. Pre-dose on Day 7, Day 14 and 21 of cycle 1. Each cycle is 28 days.
Title
Area under blood concentration-time curve (AUC)
Description
After administration, the area under the curve is obtained using the blood drug concentration as the ordinate and time as the abscissa.
Time Frame
Pre-dose, 30 minutes, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours after dose on Day 1 and Day 28 of Cycle 1. Pre-dose on Day 7, Day 14 and 21 of cycle 1. Each cycle is 28 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with advanced lung cancer or ovarian cancer confirmed by histopathology or cytology; Age: 18~75 years old (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) score: 0-1; At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1; Normal function of main organs The serum Human Chorionic Gonadotropin (HCG) test of female patients of childbearing age must be negative within 7 days before study enrollment and must be non-lactating; The patient should agree to use contraception during the study period and within 6 months after the end of the study period;Male subjects should agree to use contraception during the study period and for 6 months after the study period ends; The patient voluntarily joined the study and signed the informed consent form, with good compliance. Exclusion Criteria: Combined with the following diseases or medical history: Other malignant tumors have occurred or are present at the same time within<3 years before the first administration. Inability to tolerate multiple factors affecting oral medication due to any reason; Common Terminology Criteria for Adverse Events (CTCAE) 5.0 > grade 1 therapeutic toxicity caused by any previous treatment that has not been completely relieved, excluding hair loss; Major surgical treatment or obvious traumatic injury was received within 4 weeks before the first administration; The presence of unhealed wounds, fractures, gastric and duodenal active ulcers, persistent positive fecal occult-blood, ulcerative colitis, or other conditions determined by investigators that may cause gastrointestinal bleeding or perforation; Arteriovenous thrombosis, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc., occurred within 6 months before the first medication; Those who have a history of psychotropic drug abuse and cannot abstain or have mental disorders; Subjects with any severe and/or uncontrollable disease; Tumor related symptoms and treatment: Had received chemotherapy, radiation, or other anticancer therapy within 4 weeks prior to first dose; Within 2 weeks before the first dose, received Chinese Traditional drugs with anti-tumor indications specified in theNational Medical Products Administration (NMPA) approved drug instructions Previously treated with anti-angiogenic drugs such as Cabozantinib, Anlotinib, Endostar and Bevacizumab; Imaging Computed Tomography (CT)or Magnetic Resonance Imaging (MRI) shows that the tumor has invaded important blood vessels or the investigator determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study; There is a history of interstitial lung disease, severe impairment of lung function, severe pulmonary fibrosis, severe radiation pneumonia, drug-induced lung disease, and evidence of severe active lung inflammation indicated by chest CT examination during screening; There are uncontrolled pleural effusion, ascites and moderate or above pericardial effusion requiring repeated drainage; Patients with brain metastases accompanied by symptoms or symptoms controlled for less than 2 weeks; Patients who have participated in and used other antitumor investigational drugs within 4 weeks before the first dose; Central squamous cell carcinoma (lung cancer subjects) with great risk of hemoptysis; Patients with concomitant diseases that, in the opinion of the investigators, seriously endanger the safety of the patients or affect the completion of the study, or who are not suitable for inclusion for other reasons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Wang, Doctor
Phone
+86 13973135460
Email
wanghui@hnca.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Zhang, Doctor
Phone
+86 13512185932
Email
shfkzp@163.com
Facility Information:
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Wang, Doctor
Phone
+86 13973135460
Email
wanghui@hnca.org.cn
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Meng, Doctor
Phone
+86 0731-88618116
Email
Mj03777@163.com
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingxiang Xu, Doctor
Phone
+86 18051062315
Email
xuxx63@sina.com
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Zhang, Doctor
Phone
+86 13512185932
Email
shfkzp@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Study of AL2846 Capsules in the Treatment of Advanced Lung Tumor and Advanced Ovarian Cancer

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