Clinical trial NCT03276988: Tolerability, Safety and Pharmacokinetics Study of GX-30 in Total Thyroidectomy or Near Total Thyroidectomy Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Total Thyroidectomy
Near-total Thyroidectomy
Keywords: Thyroid cancer
Thyroidectomy
rhTSH
GX-30
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Symyoo
First posted: 2017-09-08
Enrollment: 8
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: DIAGNOSTIC

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®.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy (Part B)
timeFrame: at each Day 4, period 1 and period 2.
Secondary outcomes:
measure: TSH concentration (Part B)
timeFrame: Baseline, Day 1 to Day 8.
measure: ADA (Part B)
timeFrame: Baseline, Day 1 and 15 of Period 2
measure: Tg concentration (Part B)
timeFrame: Baseline, Day 1 to Day 5
measure: T3, free T4 concentration (Part B)
timeFrame: Baseline, Day 1, 2, 5 of each period and Day 15 of period 2.
measure: Adverse events (Part B)
timeFrame: through study completion, average of 6 weeks.
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Mu Il Kang, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.