Safety and Efficacy of Anlotinib in Combination With Irinotecan in Patients With Pretreated Advanced Colorectal Cancer

NCT03545711 | Unknown Phase 1

• 1 other identifier: NCC201803012
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with pretreated advanced colorectal cancer are recruited to the phase I portion of this prospective non-randomised study in an escalated dose cohort. The primary endpoint of the dose-escalation phase is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of anlotinib when given in combination with irinotecan. The phase II (dose-expansion) portion is designed to characterize the safety and potential efficacy of the combination therapy in pretreated advanced colorectal cancer patients.

Conditions

Colo-rectal Cancer

Outcome Measures

Primary Outcomes (2)

• MTD

  the maximum tolerated dose (MTD) of Anlotinib when administered in combination with fixed dose of irinotecan in advanced colorectal cancer patients.

  6 months

• ORR

  the overall response rate (ORR) of Anlotinib when administered in combination with fixed dose of irinotecan in advanced colorectal cancer patients.

  18 months

Secondary Outcomes (2)

• DCR

  18 months

• PFS

  18 months

Study Arms (1)

Anlotinib plus Irinotecan

EXPERIMENTAL

Drug: Anlotinib Hydrochloride with Irinotecan

Interventions

Anlotinib Hydrochloride with Irinotecan DRUG

Dose escalation of anlotinib starts from 8mg qd d1-14/q21d in combination with fixed dose of irinotecan at 180mg/m2 d1/q14d.

Anlotinib plus Irinotecan

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• willing and able to provide written informed consent and comply with the requirements of the study
• histologically- or cytologically-confirmed advanced colorectal cancer
• failed or intolerable to at least one prior therapy
• have evidence of measurable disease per RECIST v1.1
• Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1
• weight ≥40kg
• life expectancy \>12 weeks

You may not qualify if:

• Subjects meeting any of the following criteria are ineligible for participation in the study:
• history of any anti-cancer therapy (including investigational agents) within 28 days prior to study entry
• presence of toxicity of prior anti-cancer therapy that has not resolved to Grade 1, as determined by National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
• symptomatic brain metastasis requiring active treatment
• any previous malignancy, except for non squamous-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix within 5 years prior to study entry
• active or clinically unstable infection requiring systemic therapy
• unable to swallow oral medications or with gastrointestinal disorders that might interfere with proper absorption of oral drugs
• active digestive ulcer disease, inflammatory bowel disease, intestinal obstruction or any other condition that, in the clinical judgment of the Principal Investigator, may cause severe gastrointestinal bleeding or perforation
• unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic event ≤2 months prior to study entry
• history of stroke or transient ischemic attack (TIA) within 12 months prior to study entry
• any of the following abnormal findings in organ or marrow function 1 week prior to study entry:
• Leukocytes \< 1.5\*10\^9/L, or Platelets \< 100\*10\^9/L, or Hb\< 90g/L
• Total bilirubin \> 1.5 × institutional upper limit of normal (ULN), or AST (aspartate amino transferase)/ALT (alanine amino transferase)\> 3 × institutional ULN for liver metastases, \> 1.5 × institutional ULN in case of no liver metastases
• any electrolyte imbalance of clinical significance
• creatinine \> institutional ULN and creatinine clearance \< 60 mL/min

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Jing Huang

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Jing Huang, MD

  Cancer Hospital,CAMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Huang, MD

CONTACT

86-10-87788102; huangjingwg@163.com

Yan Song, M.D

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 4, 2018
• Study Start: May 26, 2018
• Primary Completion: November 24, 2019
• Study Completion: November 24, 2020
• Last Updated: August 6, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)