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

NCT04337879 | Unknown Phase 1

• 1 other identifier: AL2846-I-0004
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS defined as the time from the first dose until the first documented progressive disease (PD) or death from any cause, based on investigator.

  up to 12 month

Secondary Outcomes (3)

• Overall response rate (ORR)

  up to 12 month

• Disease control rate（DCR）

  up to 12 month

• Duration of response (DOR)

  up to 12 month

Study Arms (2)

AL2846 + mFOLFOX6

EXPERIMENTAL

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.

Drug: AL2846; Drug: Calcium folate; Drug: 5-FU; Drug: Oxaliplatin

AL2846 + FOLFIRI

EXPERIMENTAL

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.

Drug: AL2846; Drug: Calcium folate; Drug: 5-FU; Drug: Irinotecan

Interventions

AL2846 DRUG

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

AL2846 + FOLFIRI; AL2846 + mFOLFOX6

Calcium folate DRUG

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

AL2846 + FOLFIRI; AL2846 + mFOLFOX6

5-FU DRUG

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

AL2846 + FOLFIRI; AL2846 + mFOLFOX6

Oxaliplatin DRUG

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

AL2846 + mFOLFOX6

Irinotecan DRUG

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

AL2846 + FOLFIRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed advanced metastatic colorectal cancer. 2. Has received only first-line standard chemotherapy regimen for metastatic disease, and which was failed.
• \. At least one measurable lesion. 4. Has received systemic chemotherapy, palliative radiotherapy or other anti-tumor therapy before first dose at least 4 weeks.
• and 75 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
• \. Adequate laboratory indicators. 7. No pregnant or breastfeeding women, and a negative pregnancy test. 8. Understood and signed an informed consent form.

You may not qualify if:

• \. 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.
• \. 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.
• \. 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.
• \. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• \. 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.
• \. 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.
• 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.
• \. Subjects plan to receive FOLFIRI chemotherapy regimen with uridine diphosphate glucuronyltransferase homozygous variant or double hybrid variant.
• \. 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.
• \. Has participated in other clinical trials within 4 weeks before the first dose.
• \. According to the investigators' judgment.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

The First Hospital of China Medical University

Shengyang, Liaoning, 110011, China

RECRUITING

MeSH Terms

Interventions

Fluorouracil; Oxaliplatin; Irinotecan

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids

Central Study Contacts

Yunpeng Liu, Doctor

CONTACT

024-83282256; cmu_trial@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 8, 2020
• Study Start: July 20, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-01

Locations

CN (1)