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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01772732
First Posted: January 21, 2013
Last Update Posted: April 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.
  Purpose
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: None (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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772732


Contacts
Contact: Yuankai Shi, MD 86-10-87788268

Locations
China
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.
Investigators
Principal Investigator: Yuankai Shi, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  More Information

Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01772732     History of Changes
Other Study ID Numbers: SIM-101-1
First Submitted: January 15, 2013
First Posted: January 21, 2013
Last Update Posted: April 9, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms