Clinical Study of Apatinib as the Second-line Therapy in Malignant Melanoma

NCT03383237 | Unknown Phase 2

• 1 other identifier: AHEAD-HNP051
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to confirm the safety and efficacy of Apatinib as the Second-line Therapy in Malignant Melanoma.

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  From date of randomization until the date of first documented progression or date of death from any cause

  up to 2 year

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  up to 1 year

• Disease Control Rate (DCR)

  up to 1 year

• Overall survival(OS)

  up to 2 year

Study Arms (1)

Apatinib

EXPERIMENTAL

Apatinib 500mg/d,q.d.,p.o.

Drug: Apatinib

Interventions

Apatinib DRUG

500mg/d,q.d.,p.o.

Apatinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed the informed consent form prior to patient entry.
• Pathologically confirmed first-line treatment of advanced malignant melanoma patients with at least one measurable lesion.
• ≥ 18 and ≤ 70 years of age.
• Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
• Life expectancy of more than 3 months.
• Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 100×109/L, HB ≥ 90 g/L, TBIL ≤ 1.5×ULN, ALT or AST ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1.5×ULN, Cr clearance ≥ 60 mL/min;Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%).
• Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 6 months after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 6 months after last dose of study drug.

You may not qualify if:

• uncontrollable hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal medical therapy), grade II The above myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc interval male ≥ 450 ms, female ≥ 470 ms).
• Patients previously treated with anticancer therapies also have a Toxicity Level\> 1 in NCI CTCAE.
• A variety of factors that affect oral absorption (such as inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).
• Patients with gastrointestinal bleeding risk may not be included, including the following: (1) active peptic ulcer lesions and fecal occult blood (++); (2) history of melena and vomiting within 3 months; (3) ) For fecal occult blood (+) must be gastroscopy, clear whether the existence of gastrointestinal organic diseases.
• Coagulation dysfunction (INR\> 1.5, PT\> ULN + 4s or APTT\> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment.
• Long-term, unhealed wounds or fractures.
• Active bleeding, within 30 days after major surgery.
• Intracranial metastasis.
• Pregnant or lactating women.
• Cytotoxic drug treatment, radiotherapy within 3 weeks after treatment; had taken two or more targeted drugs, or into the group before the other three months have been taking other targeted drugs.
• Other malignant tumors in the past 3 years.
• The investigators believe there is any condition that may harm the subject or result in the subject's inability to meet or perform the research requirements.
• Huge metastasis / recurrence (tumor diameter\> 5 cm)。
• Malignant pleural effusion or ascites, causing NCI CTCAE grading 2 or more people with dyspnea.
• Any allergy to apatinib should be excluded.

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

Related Publications (1)

• Yuan S, Fu Q, Zhao L, Fu X, Li T, Han L, Qin P, Ren Y, Huo M, Li Z, Lu C, Yuan L, Gao Q, Wang Z. Efficacy and Safety of Apatinib in Patients with Recurrent or Refractory Melanoma. Oncologist. 2022 Jun 8;27(6):e463-e470. doi: 10.1093/oncolo/oyab068. Erratum In: Oncologist. 2022 Aug 5;27(8):e684. doi: 10.1093/oncolo/oyac103.

  PMID: 35348754 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

apatinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zibing Wang

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zibing Wang

CONTACT

18937621301; bingziwang@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 26, 2017
• Study Start: November 29, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: December 27, 2017

Record last verified: 2017-11

Locations

CN (1)