Sutetinib for Non-Small Cell Lung Cancer
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Teligene US
Must not be taking: EGFR-TKIs, Chemotherapy
Disqualifiers: Active CNS metastases, Uncontrolled infection, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The main objective of the study will be to evaluate the efficacy of sutetinib maleate capsules in participants with locally advanced or metastatic non-small cell lung cancer NSCLC (uncommon EGFR mutations only).
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before joining. You must not have used any systemic anti-tumor therapy, including chemotherapy or radiation, within 3 weeks before enrolling. Additionally, you should avoid drugs or foods that affect the enzyme CYP3A4 within 14 days before starting the trial.
What data supports the effectiveness of the drug Sutetinib for non-small cell lung cancer?
Research shows that sunitinib malate, a component of Sutetinib, has shown promising activity in treating advanced non-small cell lung cancer (NSCLC) with a 10% response rate in patients who had previously undergone chemotherapy. This suggests that Sutetinib may have potential benefits for NSCLC patients.
12345Is sunitinib safe for humans?
Sunitinib, also known as Sutent, has been studied for safety in various conditions and has shown a good safety profile in healthy subjects and patients with different types of cancer, including gastrointestinal stromal tumors and renal cell carcinoma.
15678How is the drug Sutetinib different from other treatments for non-small cell lung cancer?
Sutetinib (Sunitinib Malate) is unique because it is a multi-targeted drug that inhibits several key pathways involved in tumor growth, such as VEGF and PDGF receptors, and is given on a specific schedule of 4 weeks on treatment followed by 2 weeks off. This approach is different from many standard treatments for non-small cell lung cancer, which may not target multiple pathways or follow this specific dosing schedule.
158910Eligibility Criteria
Adults with advanced or metastatic non-small cell lung cancer (NSCLC) that have uncommon EGFR mutations can join. They should have at least one measurable tumor, good organ function, an ECOG score of 0-2, and a life expectancy over 3 months. People who've had certain treatments recently or have active infections, brain metastases, trouble swallowing pills, or use drugs affecting CYP3A4 can't participate.Inclusion Criteria
My lung cancer is confirmed to be advanced or has spread.
My tumor has a rare EGFR mutation.
My blood, liver, kidney, and clotting tests are within normal ranges.
+4 more
Exclusion Criteria
I cannot swallow pills or have chronic stomach issues affecting food absorption.
I do not have any uncontrolled infections.
I have no side effects from previous treatments above mild, except for hair loss.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive sutetinib maleate capsules orally for 28-day cycles
12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Participant Groups
The trial is testing Sutetinib Maleate Capsules to see how effective they are for NSCLC patients with specific genetic changes in their tumors. It's focused on those who haven't used certain other cancer drugs before.
1Treatment groups
Experimental Treatment
Group I: Single arm, Open labelExperimental Treatment1 Intervention
Participants will receive sutetinib maleate capsule taken orally with (preferred) or without food, at the dose directed by the Investigators, 28 days for a cycle.
Sutetinib Maleate Capsule is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Sutent for:
- Gastrointestinal Stromal Tumor (GIST)
- Renal Cell Carcinoma (RCC)
- Pancreatic Neuroendocrine Tumors (pNET)
🇪🇺 Approved in European Union as Sutent for:
- Gastrointestinal Stromal Tumors (GIST)
- Renal Cell Carcinoma (RCC)
- Pancreatic Neuroendocrine Tumors (pNET)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwell HealthNew Hyde Park, NY
University of Texas MD Anderson Cancer CenterHouston, TX
University of California San Diego Moores Cancer CenterLa Jolla, CA
Moffitt Cancer CenterTampa, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Teligene USLead Sponsor
References
Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer. [2021]Sunitinib malate (SUTENT) has promising single-agent activity given on Schedule 4/2 (4 weeks on treatment followed by 2 weeks off treatment) in advanced non-small cell lung cancer (NSCLC).
A randomized, phase II study of vandetanib maintenance for advanced or metastatic non-small-cell lung cancer following first-line platinum-doublet chemotherapy. [2022]This randomized, phase II study investigated whether benefit could be obtained by giving vandetanib, an oral inhibitor of vascular endothelial and epithelial growth factor receptor, as a maintenance treatment in non-small cell lung cancer (NSCLC).
Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer. [2022]Aberrant vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) signaling have been shown to play a role in non-small-cell lung cancer (NSCLC) pathogenesis and are associated with decreased survival. We evaluated the clinical activity and tolerability of sunitinib malate (SU11248), an oral, multitargeted tyrosine kinase inhibitor that blocks the activity of receptors for VEGF and PDGF, as well as related tyrosine kinases in patients with previously treated, advanced NSCLC.
Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma and various other solid tumors. [2018]SU11248 sunitinib malate sutent is a selective inhibitor of certain protein tyrosine kinases including VEGF-R types 1-3 PDGF-R-a and -b, c-kit, and RET. Its antitumor activity may result from both inhibition of angiogenesis and direct antiproliferative effects on certain tumor types. In several phase I/II/III studies, sutent was found to be effective as second and first line treatment in metastatic renal cell carcinoma (RCC). In fact, with a 37% response rate and an additional 48% stable disease sutent became the drug of choice for first line treatment in RCC. Sutent was also effective as second line treatment in patients with gastrointestinal stromal tumors (GIST) with 8% response rate, 70% stable disease and a 20-month median survival. Prolonged stable disease was also documented in neuroendocrine tumors. In addition, a phase II study in multitreated women with breast cancer, sutent demonstrated a moderate activity with 16% clinical benefit. Finally, in non-small cell lung cancer (NSCLC) in patients' progressing on chemotherapy sutent was able to achieve a 10% response rate, a level of activity similar to those documented by other agents approved for lung cancer. The agent is being tested in other tumors with a modified schedule of dosage.
Sunitinib inhibits MEK/ERK and SAPK/JNK pathways and increases sodium/iodide symporter expression in papillary thyroid cancer. [2018]Sunitinib malate (Sutent, Pfizer, Inc.; SU11248) is a selective, multitargeted inhibitor of receptor tyrosine kinases and has been shown to inhibit receptors for VEGF, PDGF, KIT, FLT3, and RET. The objective of this study was to determine the effects of sunitinib on signal transduction pathways and on gene expression of iodide-metabolizing proteins in papillary cancer cells with the RET/PTC1 rearrangement.
Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma. [2022]To describe the Food and Drug Administration (FDA) review and approval of sunitinib malate (Sutent). Sunitinib received regular approval for the treatment of gastrointestinal stromal tumor (GIST) after disease progression or intolerance to imatinib mesylate (Gleevec). Additionally, sunitinib received accelerated approval for the treatment of advanced renal cell carcinoma.
Pharmacokinetics and bioequivalence of sunitinib and Sutent® in Chinese healthy subjects: an open-label, randomized, crossover study. [2023]Purpose: The purpose of this study was to examine the pharmacokinetics (PK), bioequivalence and safety of generic sunitinib and its original product Sutent® in healthy Chinese subjects through a phase-I clinical trial. Methods: The study selected two groups of 24 healthy Chinese subjects in a 1:1 ratio through random allocation. Each participant received either 12.5 mg of sunitinib or Sutent® per cycle. A total of 15 different time points were employed for blood sample collection during each cycle. Furthermore, a comprehensive assessment of the drugs' safety was consistently maintained throughout the trial. Results: The average adjusted geometric mean ratios (GMR) (90% CI) for the primary PK parameters Cmax, AUC0-t and AUC0-∞ were 97.04% (93.06%-101.19%), 98.45% (93.27%-103.91%) and 98.22% (93.15%-103.56%), respectively. The adjusted GMRs for essential pharmacokinetic (PK) parameters all met the requirements for bioequivalence, with values within the acceptable range of 80%-125%. In addition, the two drugs showed comparable results for the other PK parameters. These results indicate that the two drugs were bioequivalent. Furthermore, both drugs showed well safety. Conclusion: The research results proved that the PK and safety profiles of sunitinib in healthy Chinese subjects were comparable to those of Sutent®. These results advocate the clinical application of generic sunitinib as a potential alternative to original product Sutent® in the treatment of certain medical conditions.
The potential of sunitinib as a therapy in ovarian cancer. [2018]Sunitinib malate (SU11248; Sutent®; Pfizer, Inc., New York) is a multi-kinase inhibitor currently approved for use in advanced renal cell carcinoma (RCC), imatinib-resistant/-intolerant gastrointestinal stromal tumours and progressive, well-differentiated pancreatic neuroendocrine tumours in patients with unresectable, locally advanced or metastatic disease.
Sunitinib malate synergistically potentiates anti-tumor effect of gemcitabine in human bladder cancer cells. [2021]Sunitinib malate (Sutent; Pfizer, New York, NY, USA) is a highly selective multi-targeted agent and has been reported to have potent anti-tumor effects against various tumors, including renal cell carcinoma and gastrointestinal stromal tumors. In this study, we explored in vitro the anti-tumor effect and related molecular mechanisms of sunitinib malate against human bladder cancer cell lines. We also determined the synergistic anti-tumor effect between sunitinib and conventional cytotoxic drugs, cisplatin and gemcitabine, in bladder cancer cells.
Targeting VEGF-VEGFR Pathway by Sunitinib in Peripheral Primitive Neuroectodermal Tumor, Paraganglioma and Epithelioid Hemangioendothelioma: Three Case Reports. [2022]Sunitinib malate (Sutent(TM); Pfizer Inc., New York, N.Y., USA) is a small molecule kinase inhibitor with activity against a number of tyrosine kinase receptors, including vascular endothelial growth factor receptors, stem-cell factor receptor, and platelet-derived growth factor receptors alpha and beta. Sunitinib, registered for the treatment of renal cell carcinoma and gastrointestinal stromal tumors, has recently been approved for the treatment of patients with advanced pancreatic neuroendocrine tumors. Peripheral primitive neuroectodermal tumor (pPNET), paraganglioma (PGL) and epithelioid hemangioendothelioma (EHE) are rare tumors in which there is an overexpression of pro-angiogenic factors and in which a high intratumoral microvessel density is a significant poor prognostic factor. On the basis of this preclinical rationale and the lack of effective treatments in pre-treated advanced stages of these rare diseases, we report our interesting experience of pPNET, PGL and EHE treatment with sunitinib.