A Study of AL2846 Capsule Combined With Standard Chemotherapy Regimen in Subjects With Advanced Colorectal Cancer

NCT ID: NCT04337879

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-20
• Study Completion Date: 2020-12-31

Brief Summary

This is a study to explore the safety, tolerance and efficacy of AL2846 capsules combined with mFOLFOLX6 or FOLFIRI standard chemotherapy regimen in subjects with advanced metastatic colorectal cancer.

Conditions

Advanced Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AL2846 + mFOLFOX6

AL2846 capsule administered orally,once daily in 28-day cycle; oxaliplatin 85mg/ ㎡ administered intravenously (IV) on day 1, day 15 in 28-day cycle；calcium folate 400mg/ ㎡ IV on day 1, day 15 in 28-day cycle；5-fu 2800mg/ ㎡ IV on day 1, 2, 15, 16 in 28-day cycle.

Group Type: EXPERIMENTAL

AL2846

Intervention Type: DRUG

AL2846 is a multi-target receptor tyrosine kinase inhibitor, which has obvious selectivity for c-met.

Calcium folate

Intervention Type: DRUG

Calcium folate 400mg/ ㎡ IV on day 1,15 in 28-day cycle

5-FU

Intervention Type: DRUG

5-FU 2800mg/ ㎡ IV on day 1, 2, 15, 16 days in 28-day cycle.

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin 85mg/ ㎡ administered intravenously (IV) on day 1, day 15 in 28-day cycle.

AL2846 + FOLFIRI

AL2846 capsule administered orally,once daily in 28-day cycle; irinotecan 180mg/㎡ administered intravenously (IV) on day 1,15 in 28-day cycle; calcium folate 400mg/ ㎡ IV on day 1,15 in 28-day cycle; 5-fu 2800mg/ ㎡ IV on day 1, 2, 15, 16 days in 28-day cycle.

Group Type: EXPERIMENTAL

AL2846

Intervention Type: DRUG

AL2846 is a multi-target receptor tyrosine kinase inhibitor, which has obvious selectivity for c-met.

Calcium folate

Intervention Type: DRUG

Calcium folate 400mg/ ㎡ IV on day 1,15 in 28-day cycle

5-FU

Intervention Type: DRUG

5-FU 2800mg/ ㎡ IV on day 1, 2, 15, 16 days in 28-day cycle.

Irinotecan

Intervention Type: DRUG

Irinotecan 180mg/㎡ administered intravenously (IV) on day 1,15 in 28-day cycle.

Interventions

AL2846

AL2846 is a multi-target receptor tyrosine kinase inhibitor, which has obvious selectivity for c-met.

Intervention Type: DRUG

Calcium folate

Calcium folate 400mg/ ㎡ IV on day 1,15 in 28-day cycle

Intervention Type: DRUG

5-FU

5-FU 2800mg/ ㎡ IV on day 1, 2, 15, 16 days in 28-day cycle.

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin 85mg/ ㎡ administered intravenously (IV) on day 1, day 15 in 28-day cycle.

Intervention Type: DRUG

Irinotecan

Irinotecan 180mg/㎡ administered intravenously (IV) on day 1,15 in 28-day cycle.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-1. Histologically confirmed advanced metastatic colorectal cancer. 2. Has received only first-line standard chemotherapy regimen for metastatic disease, and which was failed.

3. At least one measurable lesion. 4. Has received systemic chemotherapy, palliative radiotherapy or other anti-tumor therapy before first dose at least 4 weeks.

5.18 and 75 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.

6. Adequate laboratory indicators. 7. No pregnant or breastfeeding women, and a negative pregnancy test. 8. Understood and signed an informed consent form.

Exclusion Criteria

• 1. Diagnosed and/or treated additional malignancy within 5 years with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix.

2. Has received radiotherapy, chemotherapy and surgery before and less than 4 weeks from the first administration and less than 5 half-lives of oral targeted drugs after the completion of treatment.

3. Has multiple factors that affect oral medications. 4. Has gastroduodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation.

5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.

6. Has arterial or deep vein thrombosis events in 6 months. 7. Hypersensitivity to AL2846 or its excipient. 8. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear.

9. Has symptomatic brain metastases, spinal cord compression, and cancerous meningitis within 8 weeks,or brain or pia mater disease confirmed by CT or MRI examination before the first dose.

10.Has adverse events caused by previous therapy that did not recover to ≤ grade 1, with the exception of alopecia or ≥ grade 2 neurotoxicity caused by Oxaliplatin.

11. Subjects plan to receive FOLFIRI chemotherapy regimen with uridine diphosphate glucuronyltransferase homozygous variant or double hybrid variant.

12. Has drug abuse history that unable to abstain from or mental disorders. 13. Has any serious and/or uncontrolled disease. 14. Has received allogeneic organ transplants, hematopoietic stem cell transplants or bone marrow transplants.

15. Has participated in other clinical trials within 4 weeks before the first dose.

16. According to the investigators' judgment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Hospital of China Medical University

Shengyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yunpeng Liu, Doctor

Role: CONTACT

cmu_trial@163.com

024-83282256

Facility Contacts

Yunpeng Liu, Doctor

Role: primary

cmu_trial@163.com

Other Identifiers

AL2846-I-0004

Identifier Type: -

Identifier Source: org_study_id