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Study of Anlotinib in Patients With Soft Tissue Sarcoma(STS)(ALTER0203)

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.
 
ClinicalTrials.gov Identifier: NCT02449343
Recruitment Status : Unknown
Verified April 2017 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : May 20, 2015
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary:
Compare the effects and safety of Anlotinib with placebo in patients with soft tissue sarcoma.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Drug: Anlotinib Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Registered Randomized, Double-Blind, Placebo-Controlled (2:1), Multi-Centered Clinical Trial of Anlotinib as a Treatment for Soft Tissue Sarcoma
Actual Study Start Date : May 12, 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anlotinib
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: Anlotinib
Anlotinib p.o. qd

Placebo Comparator: Placebo
Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: Placebo
Placebo p.o. qd




Primary Outcome Measures :
  1. Progress free survival (PFS) [ Time Frame: up to 24 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: up to 24 months ]
  2. Objective Response Rate (ORR) [ Time Frame: up to 24 months ]
  3. Disease Control Rate (DCR) [ Time Frame: up to 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed and dated informed consent
  • Histological documentation of Soft Tissue Sarcoma,including Synovial sarcoma、Leiomyosarcoma、Alveolar soft part sarcoma、Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma、Adipocytic Tumors、Fibrosarcoma、Clear cell sarcoma、Epithelioid sarcoma,With measurable disease.
  • Within the past 6 months, using at least one failure of chemotherapy regimens (including anthracycline-based) in treating patients(except alveolar soft part sarcoma)
  • 18-70years,ECOG PS:0-1,Life expectancy of more than 3 months
  • Main organs function is normal
  • The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it

Exclusion Criteria:

  • Prior treatment with Anlotinib
  • With pleural effusion or ascites, cause respiratory syndrome
  • Accepted the vascular endothelial growth inhibitor class targeted drug treatment of patients
  • Plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping
  • Symptoms of brain metastases cannot be controlled and treated within less than 2 months
  • With severe and failed to controlled diseases
  • Occurred venous thromboembolic events within 6 months

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): NCT02449343


Locations
Show Show 25 study locations
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT02449343    
Other Study ID Numbers: ALTN-02-IIB
First Posted: May 20, 2015    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms