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Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of Simotinib Hydrochloride in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 1
18 Years
65 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of Simotinib Hydrochloride in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

- Patients with histologically or cytologically confirmed diagnosis of advanced NSCLC,
who were previously treated with at least one platinum-based chemotherapy regimen,
but had disease relapse;

- Patients have ended their chemotherapy or radiotherapy at least 4 weeks prior to
study entry and have recovered from any previous toxicity;

- EGFR mutation positive (such as E19del、L858R、L861Q、G719X, etc.);

- Patients with at least one measurable lesion meeting RECIST;

- ECOG performance status 0-2;

- Life expectancy ≥12 weeks;

- Adequate bone marrow function: ANC ≥1.5 × 109/L, PLT≥80 ×109/L, HB ≥90 g/L;

- Adequate hepatic function: serum bilirubin ≤ 2 × ULN, AST and ALT ≤ 2.5 × ULN, and ≤
5 × ULN are acceptable if the liver has tumor involvement;

- Adequate renal function: endogenous creatinine clearance rate (CrCl) ≥ 60 mL/min or
serum creatinine ≤ 1.5 × ULN;

- Females with childbearing potential must have a negative pregnancy test within 7 days
prior to treatment and use an approved contraceptive method during the study;

- Males must be surgically sterile or use an approved contraceptive method during the

Exclusion Criteria:

- Patients who were previously treated by EGFR inhibitor or other molecular targeting
drugs (micromolecular drugs or monoclonal antibodies) such as Iressa, Tarceva,
Sutent, Nexavar, Sprycel, Erbitux, Nimotuzumab, Icotinib, Herceptin, etc.;

- The known hypersensitivity to Simotinib or any of the excipients;

- Concurrent treatment with rifampin, rifabutin, rifapentine, dexamethasone, phenytoin
sodium, carbamazepine, phenobarbital, Hypericum perforatum, atazanavir,
clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir,
ritonavir, saquinavir, and telithromycin;

- CNS metastasis diagnosed recently which has not received surgery or radiotherapy;

- Evidence of interstitial lung disease;

- Pre-existing idiopathic pulmonary fibrosis as evidenced by CT scan at baseline;

- Any serious or uncontrollable systemic disease (such as unstable respiratory
disorders, cardiovascular, hepatic or kidney disorders);

- Any unstable systemic disorders (including active infection, uncontrollable
hypertension, unstable angina pectoris, congestive heart failure, liver and kidney
disorders or metabolism disease);

- Other malignancies diagnosed within the last 5 years with the exception of completely
cured cervical cancer in situ, or basal and squamous cell skin cancer;

- Any remarkable eye disorders, especially severe dry eye syndrome,
keratoconjunctivitis sicca, herpes keratitis;

- History of nerve or psychiatric disorders, including epilepsy or dementia.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD)

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Yuankai Shi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute and Hospital, Chinese Academy of Medical Sciences


China: Food and Drug Administration

Study ID:




Start Date:

December 2012

Completion Date:

October 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Simotinib
  • Non-small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms