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Study of Anlotinib in Patients With Medullary Thyroid Carcinoma(ALTER01031)

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: NCT02586350
Recruitment Status : Completed
First Posted : October 26, 2015
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary:
To compare the effects and safety of Anlotinib with placebo in patients with Medullary Thyroid Carcinoma.

Condition or disease Intervention/treatment Phase
Medullary Thyroid Carcinoma Drug: Anlotinib Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Medullary Thyroid Carcinoma(ALTER01031)
Study Start Date : July 2015
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018


Arm Intervention/treatment
Experimental: Anlotinib
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.Subjects with confirmation of disease progression by independent imaging review, while receiving blinded study drug may request to receive open label Anlotinib and enter the Optional Open Label Anlotinib Treatment Period of the Extension Phase. Subjects who request to receive open label Anlotinib(at the time of confirmed progression) will be informed whether they received placebo or Anlotinib during the period of blinded study drug administration. Subjects who received Anlotinib will not be eligible for the open-label phase.
Drug: Anlotinib
Other Name: 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.Subjects with confirmation of disease progression by independent imaging review, while receiving blinded study drug may request to receive open label Anlotinib and enter the Optional Open Label Anlotinib Treatment Period of the Extension Phase. Subjects who request to receive open label Anlotinib(at the time of confirmed progression) will be informed whether they received placebo or Anlotinib during the period of blinded study drug administration.
Drug: Placebo
Placebo p.o. qd




Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: Date of randomization to the date of disease progression (measured every 6 weeks) or death (whichever occurs first) as determined by blinded independent imaging review(assessed up to 24 months) ]
    To compare the Progression-free Survival (PFS) of subjects with medullary thyroid carcinoma(MTC) with Anlotinib versus Placebo.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Date of randomization to the date of disease progression (measured every 6 weeks) or death (assessed up to 24 months) ]
    To compare Overall Response Rate (ORR) (Complete and Partial Responses, CR and PR) of subjects treated with Anlotinib versus Placebo.



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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:

  1. Signed and dated informed consent
  2. Histological documentation of medullary thyroid carcinoma(MTC),Unable to surgery(Stage IV) or metastasis ,With measurable disease (using RECIST1.1)
  3. ECOG PS:0-1,Life expectancy of more than 6 months
  4. main organs function is normal

Exclusion Criteria:

  1. Prior treatment with Anlotinib or VEGFR-targeted therapies(such as Vandetanib,Cabozantinib,Lenvatinib,Sunitinib,Sorafenib etc.)
  2. Subjects received radiotherapy external exposure within 3 months prior to the first dose of study drug or plan to be received any anti-cancer treatment during study
  3. Patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer [ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma invasion into lamina propria) ]
  4. CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments,excluding alopecia and Grade 2 or lower neurotoxicity induced by oxaliplatin
  5. Patients with factors that could affect oral medication (such as dysphagia etc.)
  6. Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea [Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life])
  7. Patients underwent major surgical treatment,open biopsy or significant traumatic injury within 28 days prior to assignment

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): NCT02586350


Locations
Show Show 19 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: NCT02586350    
Other Study ID Numbers: ALTN-01-IIMTC
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Carcinoma
Thyroid Neoplasms
Carcinoma, Neuroendocrine
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue