To hear about similar clinical trials, please enter your email below
Trial Title:
Clinical Study of AL2846 Capsules in the Treatment of Advanced Lung Tumor and Advanced Ovarian Cancer
NCT ID:
NCT05815862
Condition:
Advanced Lung Cancer
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AL2846 capsule
Description:
AL2846 is a multi-target tyrosine kinase inhibitor.
Arm group label:
AL2846 capsule
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.
Criteria for 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:
1. Other malignant tumors have occurred or are present at the same time within<3
years before the first administration.
2. Inability to tolerate multiple factors affecting oral medication due to any
reason;
3. 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;
4. Major surgical treatment or obvious traumatic injury was received within 4
weeks before the first administration;
5. 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;
6. 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;
7. Those who have a history of psychotropic drug abuse and cannot abstain or have
mental disorders;
8. Subjects with any severe and/or uncontrollable diseaseļ¼
- Tumor related symptoms and treatment:
1. Had received chemotherapy, radiation, or other anticancer therapy within 4
weeks prior to first dose;
2. 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
3. Previously treated with anti-angiogenic drugs such as Cabozantinib, Anlotinib,
Endostar and Bevacizumab;
4. 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;
5. 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;
6. There are uncontrolled pleural effusion, ascites and moderate or above
pericardial effusion requiring repeated drainage;
7. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Wang, Doctor
Phone:
+86 13973135460
Email:
wanghui@hnca.org.cn
Facility:
Name:
The Third Xiangya Hospital of Central South University
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Meng, Doctor
Phone:
+86 0731-88618116
Email:
Mj03777@163.com
Facility:
Name:
Northern Jiangsu People's Hospital
Address:
City:
Yangzhou
Zip:
225009
Country:
China
Status:
Recruiting
Contact:
Last name:
Xingxiang Xu, Doctor
Phone:
+86 18051062315
Email:
xuxx63@sina.com
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Peng Zhang, Doctor
Phone:
+86 13512185932
Email:
shfkzp@163.com
Start date:
February 15, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05815862
