Study to Evaluate the Safety, Preliminary Efficacy and Pharmacokinetics of 3810
An Open-label Phase Ib, Study, to Determine Safety of Oral AL3810 in Patients With Locally Advanced or Metastatic Gastric, Hepatocellular or Nasopharyngeal Carcinoma
1 other identifier
interventional
60
1 country
7
Brief Summary
This project intends to make a study of personalized medicine evaluation system establishment for liver cancer, gastric cancer and nasopharynx cancer to provide strong support for the development of Precision Medicine and personalized medicine for the patients of high-incidence-rates cancer in China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2017
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2017
CompletedFirst Posted
Study publicly available on registry
August 24, 2017
CompletedStudy Start
First participant enrolled
August 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedAugust 24, 2017
August 1, 2017
1.4 years
July 20, 2017
August 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
AE
the number of patients with grade 3 and 4 AE according to CTC AE 4.03
through study completion, an average of 1 year
Secondary Outcomes (6)
ORR
through study completion, an average of 1 year
AUC
up to 3 cycles(28 days/cycle)
Cmax
up to 3 cycles(28 days/cycle)
DoR
through study completion, an average of 1 year
DCR
through study completion, an average of 1 year
- +1 more secondary outcomes
Other Outcomes (3)
CD4+/CD8+
from baseline up to six months(every 8 weeks±7 days )
Growth factor
from baseline up to six months(every 8 weeks±7 days ), C1D15
Exosomes
from baseline up to six months(every 8 weeks±7 days )
Study Arms (3)
gastric carcinoma
EXPERIMENTAL20 gastric carcinoma patients were randomly divided into two groups: 4W on or 3w on/1w off, oral AL3810
hepatocellular carcinoma
EXPERIMENTAL20 hepatocellular carcinoma patients were randomly divided into two groups: 4W on or 3w on/1w off, oral AL3810
Nasopharyngeal carcinoma
EXPERIMENTAL20 Nasopharyngeal carcinoma patients were randomly divided into two groups: 4W on or 3w on/1w off, oral AL3810
Interventions
Eligibility Criteria
You may qualify if:
- Adult male or female Chinese subject aged 18 to 70 years, inclusive, at the time of signing the informed consent form, with weight at least 40 kg when screening.
- Life expectancy ≥ 12 weeks as judged by the Investigator.
- Histologically or cytologically confirmed, locally advanced or metastatic solid tumor and be limited to:
- Gastric carcinoma (including gastro-oesophageal junction adenocarcinoma).
- Hepatocellular carcinoma (Child-Pugh Class A).
- Undifferentiated nasopharyngeal carcinoma.
- Each subject should provide at least 5 slides for the formalin fixed and paraffin embedded tumor biopsy (undyed) at the baseline, fresh biopsy or most recent primary tumor sample or metastatic sample is required.
- Patients, who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists.
- Toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade ≤ 1 as per the National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE), excluding alopecia and peripheral neuropathy. For subjects having a prior platinum-based therapy, peripheral neuropathy are required to recover to ≤ CTCAE grade 2.
- Per RECIST v1.1 guidelines for solid tumors:
- Patients with gastric carcinoma should have at least one measurable lesion beyond stomach,
- Patients with Hepatocellular carcinoma and undifferentiated nasopharyngeal carcinoma should have at least one measurable lesion.
- Adequate bone marrow and organ function as defined by the following laboratory values: (prophylactic use of myeloid growth factors (eg, G-CSF, GM-CSF) is prohibited within 2 weeks before screening)
- Absolute neutrophil count (ANC) ≥ 1.5x 109/L.
- Platelet counts ≥ 100 x 109/L.
- +47 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
The 307th Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Sun Yat-sen University
Guangzhou, Guangdong, China
The 81st Hospital of People's Liberation Army
Nanjing, Jiangsu, 210002, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
Sun Yat-sen University Cancer Center
Hangzhou, Zhejiang, China
Related Publications (1)
Zhang Y, Luo F, Ma YX, Liu QW, Yang YP, Fang WF, Huang Y, Zhou T, Li J, Pan HM, Yang L, Qin SK, Zhao HY, Zhang L. A Phase Ib Study of Lucitanib (AL3810) in a Cohort of Patients with Recurrent and Metastatic Nasopharyngeal Carcinoma. Oncologist. 2022 Jun 8;27(6):e453-e462. doi: 10.1093/oncolo/oyab076.
PMID: 35445718DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2017
First Posted
August 24, 2017
Study Start
August 31, 2017
Primary Completion
January 31, 2019
Study Completion
June 30, 2019
Last Updated
August 24, 2017
Record last verified: 2017-08