Study of Anlotinib in Patients With Medullary Thyroid Carcinoma(ALTER01031)
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ClinicalTrials.gov Identifier: NCT02586350 |
Recruitment Status :
Completed
First Posted : October 26, 2015
Last Update Posted : May 21, 2019
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Condition or disease | Intervention/treatment | Phase |
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Medullary Thyroid Carcinoma | Drug: Anlotinib Drug: Placebo | Phase 2 Phase 3 |
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 |
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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.
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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.
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Drug: Placebo
Placebo p.o. qd |
- 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.
- 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 |
Inclusion Criteria:
- Signed and dated informed consent
- Histological documentation of medullary thyroid carcinoma(MTC),Unable to surgery(Stage IV) or metastasis ,With measurable disease (using RECIST1.1)
- ECOG PS:0-1,Life expectancy of more than 6 months
- main organs function is normal
Exclusion Criteria:
- Prior treatment with Anlotinib or VEGFR-targeted therapies(such as Vandetanib,Cabozantinib,Lenvatinib,Sunitinib,Sorafenib etc.)
- 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
- 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) ]
- 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
- Patients with factors that could affect oral medication (such as dysphagia etc.)
- 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])
- Patients underwent major surgical treatment,open biopsy or significant traumatic injury within 28 days prior to assignment
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
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 |
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 |