A Study to Investigate Nicotinic Acid on VEGFR Inhibitor-Associated Hand-Foot Skin Reactions

NCT04242927 | Unknown Phase 2

• 1 other identifier: NAVI
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Hand-Foot Skin Reaction (HFSR) is a common adverse event induced by Vascular Endothelial Growth Receptor Inhibitor (VEGFRi) in cancer patients. The main purpose of this study is to evaluate the efficacy and safety of nicotinic acid in solid tumor patients with grade II/III VEGFRi-associated HFSR.

Conditions

Hand-Foot Skin Reaction (HFSR)

Outcome Measures

Primary Outcomes (2)

• Response rate of VEGFR inhibitor-associated hand-foot skin reaction

  Proportion of patients who achieve NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE) grade 0/1 (enrolled grade 2 patients) or grade 0-2 (enrolled grade 3 patients).

  2 year

• Complete response rate of VEGFR inhibitor-associated hand-foot skin reaction

  Proportion of patients who achieve NCI CTCAE v5.0 - PPE grade 0.

  2 year

Secondary Outcomes (2)

• Dose adjustment/withdrawal ratio

  2 year

• Hand-Foot Reaction Quality of Life (HF-QoL)

  2 year

Study Arms (2)

Nicotinic acid + Routine care

EXPERIMENTAL

Nicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care.

Drug: Nicotinic acid +Routine care

Routine care

ACTIVE COMPARATOR

Routinely apply urea ointment and provide best supportive care.

Drug: Routine care

Interventions

Nicotinic acid +Routine care DRUG

Nicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care.

Also known as: Nicotinic Acid 50 MG Oral Tablet

Nicotinic acid + Routine care

Routine care DRUG

Routinely apply urea ointment and provide best supportive care.

Also known as: Urea ointment

Routine care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained prior to performing any protocol-related procedures, including blood serum collecting
• HFSR grade 2 or higher after treatment with VEGFR inhibitors (such as sorafenib, regorafenib, anlotinib, and apatinib), according to NCI CTCAE V5.0 - PPE
• Age from 18 to 75 years.
• Life expectancy of at least 3 months at Day 1

You may not qualify if:

• History of allergy to B vitamins
• Major surgery or severe traumatic injury, fracture within 4 weeks prior to first dose of nicotinic acid or ulceration and any factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction
• Patient who takes isoniazid in combination with sorafenib and other VEGFR inhibitors.
• History of psychiatric drugs substance abuse and fails to quit it or has amental disorder
• Pregnant or nursing women, fertile patient who is unwilling or unable to use effective contraception

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead
• Zhejiang University: collaborator

Study Sites (1)

First People's Hospital of Hangzhou

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Interventions

Niacin; Tablets

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Shenglin Ma, MD

  First People's Hospital of Hangzhou

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xueqin Chen, MD

CONTACT

+8613735430109; chenlucy1437@aliyun.com

Shenglin Ma, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: March 9, 2020
• Primary Completion: March 9, 2021
• Study Completion: March 9, 2022
• Last Updated: April 1, 2020

Record last verified: 2020-03

Locations

CN (1)