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

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

Tracking Information

• First Submitted Date: October 22, 2015
• First Posted Date: October 26, 2015
• Last Update Posted Date: May 21, 2019
• Study Start Date: July 2015
• Actual Primary Completion Date: September 30, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 22, 2015)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 22, 2015)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Anlotinib in Patients With Medullary Thyroid Carcinoma(ALTER01031)
• 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)
• Brief Summary: To compare the effects and safety of Anlotinib with placebo in patients with Medullary Thyroid Carcinoma.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Medullary Thyroid Carcinoma

Intervention

• Drug: Anlotinib
  Other Name: Anlotinib p.o. qd
• Drug: Placebo
  Placebo p.o. qd

Study Arms

• 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.
  Intervention: Drug: Anlotinib
• 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.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 19, 2019): 91
• Original Estimated Enrollment (submitted: October 22, 2015): 90
• Actual Study Completion Date: September 30, 2018
• Actual Primary Completion Date: September 30, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02586350
• Other Study ID Numbers: ALTN-01-IIMTC
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Verification Date: May 2019