A Study of Apatinib in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer

NCT01270386 | Completed Phase 2 DMC

• 1 other identifier: HENGRUI 20101219
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. Phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival compared with placebo in patients with advanced non-squamous and non-small cell lung cancer who failed two lines of chemotherapy.

Conditions

Non-Small-Cell Lung Cancer

Keywords

NSCLC; apatinib; phase II; lung; cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  8 weeks

Secondary Outcomes (5)

• Overall Survival safety

  8 weeks

• DCR(Disease control rate)

  8 weeks

• ORR(objective response rate)

  8 weeks

• QoL(quality of life)

  8 weeks

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  8 weeks

Study Arms (2)

Apatinib

EXPERIMENTAL

Apatinib 750 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Drug: apatinib

Placebo

PLACEBO COMPARATOR

Placebo qd p.o., and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Drug: placebo

Interventions

apatinib DRUG

Apatinib 750 mg p.o. once daily

Apatinib

placebo DRUG

placebo p.o. once daily

Placebo

Eligibility Criteria

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

You may qualify if:

• ≥ 18 and ≤ 70 years of age
• Histologically or cytologic confirmed advanced non-squamous and non-small cell lung cancer.
• At least one measurable lesion which has not received radiotherapy (larger than 10 mm in diameter by spiral CT scan)
• Have failed for 2 lines of chemotherapy including EGFR-TKI.
• ECOG performance scale 0 - 1.
• Life expectancy of more than 3 months.
• Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
• More than 4 weeks after operation or radiotherapy
• More than 4 weeks for cytotoxic agents or tyrosine kinase inhibitors inhibitors
• Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10\^9/L, neutrophils ≥ 1.5×10\^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min,
• signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

You may not qualify if:

• Squamous cell carcinoma (including adenosquamous carcinoma, undifferentiated carcinoma); small cell lung cancer (including small cell and non-small cell mixed lung cancer)
• Pregnant or breastfeeding women
• Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
• Any factors that influence the usage of oral administration
• PT, APTT, TT, Fbg abnormal, Receiving the therapy of thrombolysis or anticoagulation.
• Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3).
• Long-term untreated wounds or fractures.
• Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.
• Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues; If the prothrombin time international normalized ratio (INR) ≤ 1.5, with the purpose of prevention, the use of small doses of warfarin (1mg orally, once daily) or low-dose aspirin (between 80mg to 100mg daily) is allowed.
• Abuse of alcohol or drugs
• Less than 4 weeks from the last clinical trial
• Treatment with VEGFR, PDGFR, sSRC-TKI before.
• History of any second malignancies within 3 years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead
• Sun Yat-sen University: collaborator

Study Sites (1)

Department of Medical Oncology, Cancer Center, Sun Yet-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Li Zhang, Dr

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: January 5, 2011
• Study Start: March 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 10, 2012

Record last verified: 2012-02

Locations

CN (1)