Tolerability, Safety and Pharmacokinetics Study of GX-30 in Total Thyroidectomy or Near Total Thyroidectomy Patients

NCT03276988 | Completed Phase 1 DMC

• 1 other identifier: GX30_P1/2
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 5

Brief Summary

This study is designed as a combination of phase 1 (Part A) and phase 2 (Part B). The purpose of Part A was to determine the safety, tolerability, and pharmacokinetics in patients with total thyroidectomy or near total thyroidectomy of GX-30 and it has been completed. The Part B is currently recruiting and will investigate the efficacy and safety of GX-30 compared with THYROGEN®.

Conditions

Total Thyroidectomy; Near-total Thyroidectomy

Keywords

Thyroid cancer; Thyroidectomy; rhTSH; GX-30

Outcome Measures

Primary Outcomes (1)

• Efficacy (Part B)

  I-123 Whole body scan image classification

  at each Day 4, period 1 and period 2.

Secondary Outcomes (5)

• TSH concentration (Part B)

  Baseline, Day 1 to Day 8.

• ADA (Part B)

  Baseline, Day 1 and 15 of Period 2

• Tg concentration (Part B)

  Baseline, Day 1 to Day 5

• T3, free T4 concentration (Part B)

  Baseline, Day 1, 2, 5 of each period and Day 15 of period 2.

• Adverse events (Part B)

  through study completion, average of 6 weeks.

Study Arms (2)

Part B - Sequence A

OTHER

Period 1 GX-30 0.9mg x 2 (Day 1 and Day 2), IM injection. Period 2 THYROGEN® 0.9mg x 2 (Day 1 and Day 2), IM injection

Drug: Period 1 GX-30, Period 2 THYROGEN®

Part B - Sequence B

OTHER

Period 1 THYROGEN® 0.9mg x 2 (Day 1 and Day 2), IM injection. Period 2 GX-30 0.9mg x 2 (Day 1 and Day 2), IM injection

Drug: Period 1 THYROGEN®, Period 2 GX-30

Interventions

Period 1 GX-30, Period 2 THYROGEN® DRUG

Part B - Sequence A. GX-30 0.9mg will be administered at Day 1 and Day 2 in Period 1. After wash-out period of 2 to 3 weeks, THYROGEN® 0.9mg will be administered in Period 2.

Also known as: Thyrotropin alpha

Part B - Sequence A

Period 1 THYROGEN®, Period 2 GX-30 DRUG

Part B - Sequence B. THYROGEN® 0.9mg will be administered at Day 1 and Day 2 in Period 1. After wash-out period of 2 to 3 weeks, GX-30 0.9mg will be administered in Period 2.

Also known as: Thyrotropin alpha

Part B - Sequence B

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Pregnant or lactating women will be excluded. Women of childbearing potential who agreed to use a medically appropriate conceptional method till 6 months after study completion may be enrolled.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who voluntarily consented, after listing enough explanation for this study and investigational product.
• Minimum 19 years old.
• Minimum 50kg of body weight.
• Patients who had undergone total thyroidectomy or near total thyroidectomy due to differentiated thyroid carcinoma.
• Patient undergoing thyroid hormone administration.

You may not qualify if:

• Thyroid cancer excluding differentiated thyroid carcinoma.
• Thyroidectomy excluding total thyroidectomy and near total thyroidectomy.
• Patients with heart, renal, or liver failure.
• Patients with ischemic stroke or the history of ischemic stroke.
• Smoker or Ex-smoker with less than 3 months of stopping
• Patients with migraine or the history of migraine.
• Patients that the researchers do not think fit into the group, including patients failed in compliance assessment

Sponsors & Collaborators

• Genexine, Inc.: lead
• Symyoo: collaborator

Study Sites (5)

Pusan National University Hospital

Busan, 49241, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul Asan Medical Center

Seoul, 05505, South Korea

Location

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Related Publications (5)

• Goel R, Raju R, Maharudraiah J, Sameer Kumar GS, Ghosh K, Kumar A, Lakshmi TP, Sharma J, Sharma R, Balakrishnan L, Pan A, Kandasamy K, Christopher R, Krishna V, Mohan SS, Harsha HC, Mathur PP, Pandey A, Keshava Prasad TS. A Signaling Network of Thyroid-Stimulating Hormone. J Proteomics Bioinform. 2011 Oct 29;4:10.4172/jpb.1000195. doi: 10.4172/jpb.1000195.

  PMID: 24255551 BACKGROUND

• Meier CA, Braverman LE, Ebner SA, Veronikis I, Daniels GH, Ross DS, Deraska DJ, Davies TF, Valentine M, DeGroot LJ, et al. Diagnostic use of recombinant human thyrotropin in patients with thyroid carcinoma (phase I/II study). J Clin Endocrinol Metab. 1994 Jan;78(1):188-96. doi: 10.1210/jcem.78.1.8288703.

  PMID: 8288703 BACKGROUND

• Torres MS, Ramirez L, Simkin PH, Braverman LE, Emerson CH. Effect of various doses of recombinant human thyrotropin on the thyroid radioactive iodine uptake and serum levels of thyroid hormones and thyroglobulin in normal subjects. J Clin Endocrinol Metab. 2001 Apr;86(4):1660-4. doi: 10.1210/jcem.86.4.7405.

  PMID: 11297600 BACKGROUND

• Ladenson PW, Braverman LE, Mazzaferri EL, Brucker-Davis F, Cooper DS, Garber JR, Wondisford FE, Davies TF, DeGroot LJ, Daniels GH, Ross DS, Weintraub BD. Comparison of administration of recombinant human thyrotropin with withdrawal of thyroid hormone for radioactive iodine scanning in patients with thyroid carcinoma. N Engl J Med. 1997 Sep 25;337(13):888-96. doi: 10.1056/NEJM199709253371304.

  PMID: 9302303 BACKGROUND

• Haugen BR, Pacini F, Reiners C, Schlumberger M, Ladenson PW, Sherman SI, Cooper DS, Graham KE, Braverman LE, Skarulis MC, Davies TF, DeGroot LJ, Mazzaferri EL, Daniels GH, Ross DS, Luster M, Samuels MH, Becker DV, Maxon HR 3rd, Cavalieri RR, Spencer CA, McEllin K, Weintraub BD, Ridgway EC. A comparison of recombinant human thyrotropin and thyroid hormone withdrawal for the detection of thyroid remnant or cancer. J Clin Endocrinol Metab. 1999 Nov;84(11):3877-85. doi: 10.1210/jcem.84.11.6094.

  PMID: 10566623 BACKGROUND

Related Links

• Park DJ. Thyroid and Hydrogen Peroxide. Hanyang Med Rev 2012;32:187-91

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Thyrotropin Alfa

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Thyrotropin; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Mu Il Kang, M.D., Ph. D.

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: At Part B, Both independent central efficacy assessors and participants will be masked. Investigators will be unmasked. (The Part A was open-label.)
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The Part A (Phase 1) of study has been completed in which 3 single or multiple sequentially assenting doses of GX-30 were investigated. The Part B (Phase 2) is recruiting in current in which each study participant will receive the same multiple doses of GX-30 and THYROGEN® but at different period.

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 8, 2017
• Study Start: September 7, 2017
• Primary Completion: January 20, 2020
• Study Completion: January 20, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)