Study to Evaluate the Efficacy of Afatinib in Skull Base Chordoma
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05519917 |
Recruitment Status :
Not yet recruiting
First Posted : August 29, 2022
Last Update Posted : September 30, 2022
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Condition or disease | Intervention/treatment | Phase |
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Chordoma of Clivus | Drug: Afatinib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label, Single-arm, Interventional Clinical Study to Evaluate the Efficacy of Afatinib in Skull Base Chordoma |
Estimated Study Start Date : | October 1, 2022 |
Estimated Primary Completion Date : | June 30, 2025 |
Estimated Study Completion Date : | December 30, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Afatinib
Subject meeting the inclusion criteria will take afatinib (40 mg daily) orally, 4 weeks for a cycle.
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Drug: Afatinib
Subjects will receive evaluations at the beginning of treatment, after every three cycles and at the end of the whole study. |
- Objective response rate [ Time Frame: 12 months after enrollment ]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.
- Progression-free survival [ Time Frame: 12 months after enrollment ]duration from the date of inclusion until the date of objective tumor progression or death.
- Overall survival [ Time Frame: 12 months after enrollment ]duration from the date of inclusion until the date of death.
- Duration of response [ Time Frame: 12 months after enrollment ]duration of partial response and complete response, that is, duration from effective date to the date of proved tumor progression.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- History or presence of serious cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of ≥ 3, unstable angina or poorly controlled arrhythmia, and myocardial infarction within 6 months prior to inclusion;
- 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);
- Any history of or concomitant condition that, in the opinion of the Investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05519917
Contact: Qilin Zhang, MD | 86-21-52889999 | zhangqlhuashan@163.com |
China, Shanghai | |
Huashan Hospital | |
Shanghai, Shanghai, China, 200000 |
Responsible Party: | Zhaoyun Zhang, Professor, Huashan Hospital |
ClinicalTrials.gov Identifier: | NCT05519917 |
Other Study ID Numbers: |
KY2019-610 |
First Posted: | August 29, 2022 Key Record Dates |
Last Update Posted: | September 30, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Chordoma Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Afatinib |
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