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

• Sponsor: Genexine, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03276988
• Collaborator: Symyoo (Industry)
• Enrollment: 8
• Locations: 5
• Arms: 2
• Actual Duration (Months): 28.4
• Patients Per Site: 1.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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®.

Condition or Disease	Intervention/Treatment	Phase
Total Thyroidectomy; Near-total Thyroidectomy	Drug: Period 1 GX-30, Period 2 THYROGEN®; Drug: Period 1 THYROGEN®, Period 2 GX-30	Phase 1/Phase 2

Detailed Description

Recombinant human TSH was developed to provide TSH stimulation without withdrawal of thyroid hormone. Radioiodine ablation and diagnosis with rhTSH became the standard of care treatment for patients with differentiated thyroid cancer. Stably supplying rhTSH has been the unmet need for management and follow-up procedure for thyroid remnant. GX-30 is an investigational product, developed to provide inexpensive rhTSH to patients in order to ensure stable supply of rhTSH.

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: 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.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.
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: At Part B, Both independent central efficacy assessors and participants will be masked. Investigators will be unmasked. (The Part A was open-label.)
• Primary Purpose: Diagnostic
• Official Title: A Prospective, Open-label, Dose Escalation,(Phase 1); Prospective, Randomized, Evaluator Blinded, Active-controlled, 2-sequence, 2-period, 2-treatment, Crossover(Phase 2); Phase 1/2 Clinical Trial to Evaluate the Tolerability, Pharmacokinetics, Safety and Efficacy of GX-30 Administered Intramuscularly in Patients Underwent Total Thyroidectomy or Near Total Thyroidectomy
• Actual Study Start Date: Sep 7, 2017
• Actual Primary Completion Date: Jan 20, 2020
• Actual Study Completion Date: Jan 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Part B - Sequence A 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 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.; Other Names: Thyrotropin alpha
Other: Part B - Sequence B 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; 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.; Other Names: Thyrotropin alpha

Outcome Measures

Primary Outcome Measures

1. Efficacy (Part B) [at each Day 4, period 1 and period 2.]

   I-123 Whole body scan image classification

Secondary Outcome Measures

1. TSH concentration (Part B) [Baseline, Day 1 to Day 8.]

   TSH concentration for Pharmacokinetics assessment

2. ADA (Part B) [Baseline, Day 1 and 15 of Period 2]

   Anti-Drug Antibody detection

3. Tg concentration (Part B) [Baseline, Day 1 to Day 5]

   Thyroglobulin concentration for secondary efficacy assessment

4. T3, free T4 concentration (Part B) [Baseline, Day 1, 2, 5 of each period and Day 15 of period 2.]

   Thyroid hormones concentration for pharmacodynamic assessment

5. Adverse events (Part B) [through study completion, average of 6 weeks.]

   Safety assessment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pusan National University Hospital	Busan		Korea, Republic of	49241
2	Korea University Anam Hospital	Seoul		Korea, Republic of	02841
3	Seoul Asan Medical Center	Seoul		Korea, Republic of	05505
4	Seoul St. Mary's Hospital	Seoul		Korea, Republic of	06591
5	Ajou University Hospital	Suwon		Korea, Republic of	16499

Sponsors and Collaborators

• Genexine, Inc.
• Symyoo

Investigators

• Principal Investigator: Mu Il Kang, M.D., Ph. D., Seoul St. Mary's Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

• 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. doi: 10.4172/jpb.1000195.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Genexine, Inc.
• ClinicalTrials.gov Identifier: NCT03276988
• Other Study ID Numbers: GX30_P1/2
• First Posted: Sep 8, 2017
• Last Update Posted: Sep 9, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Genexine, Inc.: Thyroid cancer; Thyroidectomy; rhTSH; GX-30

Study Results

No Results Posted as of Sep 9, 2020