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| ID | Type | Description | Link |
|---|---|---|---|
| CO-US-979-7131 | Other Identifier | Gilead |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The goal of this clinical trial is to learn if the drug, sacituzumab govitecan, works to treat:
The main question it aims to answer is whether sacituzumab govitecan can treat the 2 conditions mentioned above in a safe and effective manner.
Participants will:
Participants will continue to receive treatment with sacituzumab govitecan until their cancer stops responding to the drug or if they decide to withdraw from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Participants with metastatic/ recurrent salivary gland cancers such as adenoid cystic carcinoma, mucoepidermoid carcinoma, adenocarcinoma NOS and salivary duct carcinoma. Each treatment cycle is 3 weeks. Treatment will be continued till disease progression, unacceptable toxicity or withdrawal of consent |
|
| Cohort B | Experimental | Participants with metastatic/ recurrent well-differentiated or poorly differentiated radioactive iodine (RAI) refractory thyroid carcinoma. Each treatment cycle is 3 weeks. Treatment will be continued till disease progression, unacceptable toxicity or withdrawal of consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab govitecan | Drug | Day 1 and Day 8: Sacituzumab Govitecan will be administered at the dose of 10 mg/kg via intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR is defined as the as the percentage of participants with a complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumours (RECIST) version 1.1. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | PFS is defined as the time from treatment assignment to disease progression or death, whichever occurs first | From date of treatment assignment until first documented progression or date of death, whichever occurs earlier, assessed up to 3 years |
| Incidence of Treatment-Related Adverse Events (TRAEs) |
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Inclusion Criteria:
Exclusion Criteria:
Has untreated brain metastases or leptomeningeal metastases.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study treatment.
Has received prior radiotherapy within 2 weeks of the start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Known severe hypersensitivity reaction to Sacituzumab govitecan.
Has an active infection requiring systemic treatment. This includes TB (Bacillus Tuberculosis).
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Recent cardiovascular thromboembolic event, such as the following:
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
A WOCBP who has a positive urine pregnancy test within 72 hours prior to first dose. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Note: In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative for subject to start receiving study medication.
Is not willing to practice contraception during the study, and for up to a period of at least 6 months after the last dose of SG:
History of having received a live virus vaccination (e.g., yellow fever, MMR, nasal flu, chicken pox or Zostavax) within 4 weeks prior to the first dose of trial treatment.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wan Qin Dr Chong, MD | Contact | +65 6908 2222 | wan_qin_chong@nuhs.edu.sg | |
| Boon Cher Prof Goh, MD | Contact | +65 6908 2222 | phcgbc@nus.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Wan Qin Dr Chong, MD | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Cancer Institute Singapore | Recruiting | Singapore | 119074 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20858281 | Background | Cubas R, Zhang S, Li M, Chen C, Yao Q. Trop2 expression contributes to tumor pathogenesis by activating the ERK MAPK pathway. Mol Cancer. 2010 Sep 21;9:253. doi: 10.1186/1476-4598-9-253. | |
| 24795243 | Background | Schlumberger M, Brose M, Elisei R, Leboulleux S, Luster M, Pitoia F, Pacini F. Definition and management of radioactive iodine-refractory differentiated thyroid cancer. Lancet Diabetes Endocrinol. 2014 May;2(5):356-8. doi: 10.1016/S2213-8587(13)70215-8. Epub 2014 Jan 30. No abstract available. |
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Explain why IPD will not or might not be shared.
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| ID | Term |
|---|---|
| D012468 | Salivary Gland Neoplasms |
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000608132 | sacituzumab govitecan |
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|
The frequency and outcome of TRAEs as assessed and graded according to the CTCAE version 5.0. |
| From date of informed consent till 90 days following the date of last dose of study treatment. |
| 6-months Disease control rate (DCR) | 6-months DCR is defined to be the percentage of participants with a complete response (CR), partial response (PR) or stable disease (SD) noted as the objective response status, according to RECIST version 1.1, at 6 months after initiating study treatment. | Up to 6 months after initiating study treatment. |
| Correlation of ORR with Trop-2 expression in tumour samples | Relationship between ORR and Trop-2 expression levels measured in tumour samples. | Up to 3 years |
| 29543059 | Background | Shulin JH, Aizhen J, Kuo SM, Tan WB, Ngiam KY, Parameswaran R. Rising incidence of thyroid cancer in Singapore not solely due to micropapillary subtype. Ann R Coll Surg Engl. 2018 Apr;100(4):295-300. doi: 10.1308/rcsann.2018.0004. Epub 2018 Mar 15. |
| 22006781 | Background | Mahmood U, Koshy M, Goloubeva O, Suntharalingam M. Adjuvant radiation therapy for high-grade and/or locally advanced major salivary gland tumors. Arch Otolaryngol Head Neck Surg. 2011 Oct;137(10):1025-30. doi: 10.1001/archoto.2011.158. |
| 8879381 | Background | Licitra L, Cavina R, Grandi C, Palma SD, Guzzo M, Demicheli R, Molinari R. Cisplatin, doxorubicin and cyclophosphamide in advanced salivary gland carcinoma. A phase II trial of 22 patients. Ann Oncol. 1996 Aug;7(6):640-2. doi: 10.1093/oxfordjournals.annonc.a010684. |
| 28709407 | Background | Guan H, Guo Z, Liang W, Li H, Wei G, Xu L, Xiao H, Li Y. Trop2 enhances invasion of thyroid cancer by inducing MMP2 through ERK and JNK pathways. BMC Cancer. 2017 Jul 14;17(1):486. doi: 10.1186/s12885-017-3475-2. |
| 37633306 | Background | Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Loirat D, Tredan O, Ciruelos E, Dalenc F, Gomez Pardo P, Jhaveri KL, Delaney R, Valdez T, Wang H, Motwani M, Yoon OK, Verret W, Tolaney SM. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 Oct 21;402(10411):1423-1433. doi: 10.1016/S0140-6736(23)01245-X. Epub 2023 Aug 23. |
| 38843511 | Background | Paz-Ares LG, Juan-Vidal O, Mountzios GS, Felip E, Reinmuth N, de Marinis F, Girard N, Patel VM, Takahama T, Owen SP, Reznick DM, Badin FB, Cicin I, Mekan S, Patel R, Zhang E, Karumanchi D, Garassino MC. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. 2024 Aug 20;42(24):2860-2872. doi: 10.1200/JCO.24.00733. Epub 2024 May 31. |
| D009059 |
| Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |