Safety of the Combination of SH003 and Docetaxel in Patients With Solid Cancer

Phase I Study to Evaluate the Maximum Tolerated Dose of the Combination of SH003 and Docetaxel in Patients With Solid Cancer

The study is designed as a single Group, Dose Elevating trial which evaluates safety to confirm the final maximum tolerated dose by the combination of oral administration of SH003 to docetaxel administered patients.

Firstly, 3 subjects is recruited and administered for 21 days for the starting dose of 2,400 mg / day. If no DLT occurs, raise the dose to a secondary dose of 3,600 mg / day. If DLT occurs, additional 3 subjects are recruited and administered for 2,400mg / day. After, If two or more of the six subjects shows DLT, stop the capacity increase, whereas if DLT occurs in less than 1 person, increase the dose to 3,600 mg / day. Next, 3 subjects is recruited and administered for 21 days for a dose of 3,600 mg / day. If no DLT occurs, raise the dose to 4,800 mg / day. If DLT occurs, 3 subjects are additionally recruited and administered for 3,600 mg / day. After, If two or more of the six subjects shows DLT, stop the capacity increase, whereas if DLT occurs in less than 1 person, increase the dose to 4,800 mg / day. Finally, 3 subjects is recruited and administered for a dose of 4,800 mg / day. If no DLT occurs, complete the study. If DLT occurs, additional 3 subjects are recruited and administered for 4,800mg / day and complete the study after observation.

Study Overview

• Status: Unknown
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Combination of SH003 and Docetaxel

• Study Type: Interventional
• Enrollment (Anticipated): 9
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients aged above 19 years
2. Patients with histologically or cytologically confirmed lung cancer or breast cancer for which standard curative measures do not exist or are no longer effective
3. Patients who have not received chemotherapy, radiotherapy or surgery within the last 4 weeks and no residual toxicity associated with the previous treatment (Grade 1 or higher adverse event according to Common Terminology Criteria for Adverse Events (CTCAE) ver 5.0 from the National Cancer Institute (NCI)
4. ECOG Performance Status ≤ 2
5. Life expectancy estimated to be at least 12 weeks
6. Patients with the ability to swallow tablets
7. Patients with measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
8. Patients with proper organ function as follows i. Bone marrow function: haemoglobin ≥8 g/dL, absolute neutrophil count ≥1,500/uL, and platelets ≥ 100,000/uL ii. Liver function: total bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN) (if patients with liver metastasis, ≤ 5 times the ULN) iii. Renal function: Serum creatinine ≤ 1.5 times the ULN or creatinine clearance according to the Cockroft-Gault equation ≥ 60 ml/min
9. No possibility of pregnancy if the participant is female (over 60 years of age, without menstruation for more than one year, or underwent hysterectomy or bilateral oophorectomy). If there is a possibility of pregnancy, pregnancy test should be conducted prior to participation in the study to prove that it is not pregnancy
10. Patients who agree to use effective means of contraception during the trial and up to 8 weeks after final administration
11. Patients with the ability to understand the study and who are willing to sign a written informed consent document

Exclusion Criteria:

1. Patients undergoing any systemic therapy or regional therapy including radiotherapy, for the purpose of treating cancer
2. Participants with known hypersensitivity to any study drug component, including Astragalus membranaceus, Angelica gigas, Trichosanthes Kirilowii Maximowicz, and polysorbate 80
3. Patients with active infections requiring treatment (active hepatitis A, B, and C viruses, human immunodeficiency virus, tuberculosis)
4. Patients with history of human immunodeficiency virus infection
5. Patients with uncontrolled cardiovascular diseases (unstable angina, heart failure, myocardial infarction, hypertension that remains uncontrolled: 140/90 mm Hg or higher)
6. Patients with active cytomegalovirus infection within the past 4 weeks
7. Patients who have experienced major surgery on cerebrovascular disease such as acute coronary syndrome, stroke, etc., within the past year
8. pregnant or lactating females
9. Patient with metastatic encephalopathy with symptoms
10. Patients who have donated blood or participated in other clinical trials of medicine or medical devices within the past month
11. Patient underwent organ transplantation including allogenic stem cell transplantation
12. Patients with complications of infectious diseases
13. Patients with suspected fever caused by infection
14. Patients with substance abuse or any neurological, medical, psychological, or sociological conditions that could potentially interfere with their compliance to the study protocol or interpretation of study results
15. Patients who are judged inappropriate for the study by investigator
16. Patients who are judged to have lost their ability to consent due to accompanying disease such as dementia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Drug: Combination of SH003 and Docetaxel; Combination of SH003 and Docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose limiting toxicity	adverse event according to CTCAE	up to 4 weeks

Collaborators and Investigators

• Sponsor: Kyunghee University Medical Center

Publications and helpful links

General Publications

• Cheon C, Ko SG. Phase I study to evaluate the maximum tolerated dose of the combination of SH003 and docetaxel in patients with solid cancer: A study protocol. Medicine (Baltimore). 2020 Sep 18;99(38):e22228. doi: 10.1097/MD.0000000000022228.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: ISEE_2018_SH003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No