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Carcinoma, Basal Cell

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Neoplasms, Basal Cell

CX-4945 capsules at 1000mg BID, on Days 1 through 28 of each treatment cycle

CX-4945 capsules at 1000mg BID, on Days 1 through 21 of each treatment cycle

CX-4945 capsules at 1000mg BID, on the dosing schedule identified during the Phase I treatment duration increment part of the study

CX-4945

Jin-Ding Huang, PhD

This study is to determine the recommended phase II dose (RP2D) and schedule of CX-4945 when administered orally twice daily for 28 consecutive days, in a 4-week (28 days) cycle, in patients with locally advanced or metastatic basal cell carcinoma (BCC). The safety and tolerability of CX-4945, preliminary evidence of antitumor effect, and the effect of CX-4945 treatment on the Hh signaling pathway will also be evaluated in this study.

Basal cell carcinomas require the hedgehog (Hh) pathway for growth. Hh binding relieves the inhibitory effect of PTCH1 on Smoothened (SMO). Signal transduction by SMO then leads to the activation and nuclear localization of GLI1 transcription factors and induction of Hh target genes, many of which are involved in proliferation, survival, and angiogenesis. Hedgehog pathway inhibitors, such as vismodegib6 and sonidegib phosphate, target the G-protein-coupled receptor Smoothened (SMO) and are recommended as first-line treatment for advanced BCC or mBCC by the National Comprehensive Cancer Network. CK2 affects the terminal-most Hh signaling components. Given the roles of CK2 on the terminal step of the hedgehog signaling pathway, CK2 inhibition is unlikely to be overcome by downstream mutations within this pathway. These data thus suggest an immediately practical application of CX-4945 in Hh-driven tumors and possibly tumors resistant to SMO inhibitors.

Treatment Duration Increment and Pharmacodynamic Study of CX-4945 in Patients With Basal Cell Carcinoma (BCC)

A Phase I, Multi-Center, Open-Label, Treatment Duration Increment, Expansion, Safety, and Pharmacodynamic Study of CX-4945 Administered Orally Twice Daily to Patients With Advanced Basal Cell Carcinoma

Determination of RP2D for the expansion cohorts

The number and attribution of all adverse events (including vital signs, physical findings, and clinical laboratory results) in patients who received any amount of study drug.

The objective response will be assessed separately for patients with mBCC and locally advanced BCC.

Absence of residual BCC in patients with locally advanced BCC achieving a clinical response to CX-4945, as measured by pathological review.

The changes in GLI1 expression in fresh-frozen tissue as measured by qRT-PCR.

Senhwa Biosciences, Inc.

Patients with laBCC undergoing sonidegib treatment in routine clinical practice

Sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)

sonidegib

Ralf Gutzmer

Collect real world safety data on the use of sonidegib in adult patients with laBCC. Document major safety parameters such as on treatment deaths, adverse events (AEs)/ serious adverse events (SAEs) and discontinuation secondary to AEs.

This is a non-interventional, multinational, multi-center post-authorization safety study (PASS), to assess the safety of sonidegib administered in routine clinical practice in patients with laBCC who are not amendable to curative surgery or radiation therapy. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a specific visit schedule. For this study, each enrolled patient will be followed up for 3 years after enrollment.

Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma

A Non-interventional, Multi-national, Multi-center Post-authorization Safety Study (PASS) to Assess the Long Term Safety and Tolerability of Odomzo (Sonidegib) Administered in Patients With Locally Advanced Cell Carcinoma (laBCC)

including on-treatment deaths and discontinuation due to AEs/SAEs

in patients with: relevant polymorphism, ≥65 yrs, hepatic or renal impairment, female patients with child bearing potential using anticonceptives, anemia (hemoglobin \<9 g/dL), recent myocardial ischemia or cardiac failure, concomitant medications with known risk of creatine kinase elevation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment Duration Increment and Pharmacodynamic Study of CX-4945 in Patients With Basal Cell Carcinoma (BCC)	NCT03897036	Carcinoma, Basa...	CX-4945	18 Years -	Senhwa Biosciences, Inc.
Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma	NCT04066504	Basal Cell Carc...	sonidegib	18 Years -	Sun Pharmaceutical Industries Limited
Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma	NCT04066504	Basal Cell Carc...	sonidegib	18 Years -	Sun Pharmaceutical Industries Limited
Treatment Duration Increment and Pharmacodynamic Study of CX-4945 in Patients With Basal Cell Carcinoma (BCC)	NCT03897036	Carcinoma, Basa...	CX-4945	18 Years -	Senhwa Biosciences, Inc.
Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma	NCT04066504	Basal Cell Carc...	sonidegib	18 Years -	Sun Pharmaceutical Industries Limited

Spots Global Cancer Trial Database for labcc

Every month we try and update this database with for labcc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for labcc

Every month we try and update this database with for labcc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for labcc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.