Study to Evaluate the Efficacy of Afatinib in Skull Base Chordoma

NCT05519917 | Unknown Phase 2

• 1 other identifier: KY2019-610
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm, open label, single center, and prospective, interventional study to explore clinical efficacy of afatinib in patients with chordoma of skull base. Subject meeting the inclusion criteria will take afatinib (40 mg daily) orally, 4 weeks for a cycle. The primary objective is to assess the efficacy of afatinib in chordoma of skull base by objective response rate (ORR). The Secondary objectives is to assess progression free survival (PFS), overall survival (OS), tumor response duration and tumor shrinkage degree in patients with chordoma of skull base after using afatinib; to evaluate the safety and tolerability of afatinib in patients with chordoma of skull base.

Conditions

Chordoma of Clivus

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Proportion of patients with reduction in tumor volume to a predefined value for a minimum period. Generally, ORR is defined as the sum of complete response and partial response. The best response, that is, the best response throughout the study, will be evaluated.

  12 months after enrollment

Secondary Outcomes (3)

• Progression-free survival

  12 months after enrollment

• Overall survival

  12 months after enrollment

• Duration of response

  12 months after enrollment

Study Arms (1)

Afatinib

EXPERIMENTAL

Subject meeting the inclusion criteria will take afatinib (40 mg daily) orally, 4 weeks for a cycle.

Drug: Afatinib

Interventions

Afatinib DRUG

Subjects will receive evaluations at the beginning of treatment, after every three cycles and at the end of the whole study.

Afatinib

Eligibility Criteria

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

You may qualify if:

• Patients of 18 years and above;
• Patients with pathologically proven EGFR and/or HER2 expressing relapsed or residual chordoma of skull base, inappropriate or unwilling to receive surgery or radiotherapy;
• Adequate bone marrow function (Hb ≥ 6.0 mmol/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 75 x 109/L);
• An adequate renal function with GFR ≥ 45 ml/min calculated by Cockroft-Gault formula;
• Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≤ 3 times ULN;
• Ability to swallow medication;
• Able to understand and provide written informed consent prior to any study procedures.

You may not qualify if:

• Life expectancy of less than 3 months;
• Known hypersensitivity to afatinib;
• Major surgery less than 4 weeks prior to start of the study;
• Patients who once participated in other clinical trials within 14 days before the initiation of the study;
• Systemic anti-cancer therapy within 28 days prior to start of the study;
• No tumor progression after radiation therapy prior to start of the study;
• Known pre-existing interstitial lung disease;
• No response after 2-week active treatment for known CTCAE Grade 3 or Grade 2 rash/acne;
• Any history or presence of poorly controlled gastrointestinal disorders that may worsen after administration and could affect the absorption of the study drug (e.g. diarrhea, Crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption);
• Active hepatitis B infection (HepB sAg and/ or Hep B DNA positive), active hepatitis C infection (Hep C RNA positive), active tuberculosis and/or known HIV carrier;
• Using other drugs that may influence afatinib and cannot be discontinued during the study, including but not limited to:
• Potent P-gp inhibitors: including but not limited to ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir and amiodarone);
• Potent P-gp inducers: including but not limited to rifampin, carbamazepine, phenytoin, phenobarbital or St. John's wort).
• Pregnant or lactating women;
• Other invasive malignancies diagnosed within the last 5 years (except non-melanoma skin cancer and localized cured prostate and cervical cancer);

Sponsors & Collaborators

• Huashan Hospital: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Interventions

Afatinib

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Qilin Zhang, MD

CONTACT

86-21-52889999; zhangqlhuashan@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 29, 2022
• Study Start: October 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)