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Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of Simotinib Hydrochloride in Patients With Advanced NSCLC

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Jiangsu Simcere Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd. Identifier:
First received: January 15, 2013
Last updated: April 7, 2015
Last verified: April 2015
The primary objective is to assess the safety and tolerability of multiple doses of Simotinib Hydrochloride in NSCLC patients. The secondary objective is to determine the pharmacokinetic (PK) profile and explore the preliminary anti-tumor activity.

Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Simotinib Hydrochloride
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of Simotinib Hydrochloride in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

Further study details as provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • The maximum plasma concentration (Cmax) [ Time Frame: d1,d8,d9,d10,d15 ]
  • The time to Cmax (tmax) [ Time Frame: d1,d8,d9,d10,d15 ]
  • Area under the plasma concentration-time curve (AUC) [ Time Frame: d1,d8,d9,d10,d15 ]
  • Overall Response Rate (ORR) [ Time Frame: 1 year ]
  • Progression-free Survival (PFS) [ Time Frame: 1 year ]

Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simotinib Treatment
"3+3" design, ascending multiple doses. Simotinib Hydrochloride: 100mg, 200mg, 300mg, 400mg, 500mg, bid, for 28 days
Drug: Simotinib Hydrochloride


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 study.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01772732

Contact: Yuankai Shi, MD 86-10-87788268

Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China
Contact: Yuankai Shi, MD    86-10-87788268      
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Principal Investigator: Yuankai Shi, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  More Information

Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd. Identifier: NCT01772732     History of Changes
Other Study ID Numbers: SIM-101-1
Study First Received: January 15, 2013
Last Updated: April 7, 2015

Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:
Non-small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms processed this record on May 25, 2017