An Open-Label, Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PTX-100 Monotherapy in Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma.

Conditions

Cutaneous T-Cell Lymphoma

Brief summary

Objective response rate (ORR)

Detailed description

Further Efficacy: - Skin response as per Modified Severity-Weighted Assessment Tool (mSWAT) - Progression-free survival (PFS) - Duration of response (DOR) - Time to response (TTR) - Complete response rate (CRR) - Overall survival (OS) - Time to next (systemic) treatment (TTNT), Safety and Tolerability - Incidence, severity and nature of adverse events (AEs) - Changes from Baseline in vital signs, electrocardiogram (ECG), clinical laboratory values and Eastern Cooperative Oncology Group (ECOG) performance status (PS), PK: - PK parameters including: Cmax Tmax, Cmin, AUCtau, AUClast, AUCinf, kel, half-life (t1/2), total body CLss, Vzss, Cmax ratio (Rac-Cmax), and AUC Ratio (Rac-AUC) - Population PK model development (NCM) from data of Phase 2a and Phase 2b data - Population and individual patient PK parameters estimation

Related papers

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Interventions

DRUGPTX-100

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR)	—

Secondary

Measure	Time frame
Further Efficacy: - Skin response as per Modified Severity-Weighted Assessment Tool (mSWAT) - Progression-free survival (PFS) - Duration of response (DOR) - Time to response (TTR) - Complete response rate (CRR) - Overall survival (OS) - Time to next (systemic) treatment (TTNT), Safety and Tolerability - Incidence, severity and nature of adverse events (AEs) - Changes from Baseline in vital signs, electrocardiogram (ECG), clinical laboratory values and Eastern Cooperative Oncology Group (ECOG) performance status (PS), PK: - PK parameters including: Cmax Tmax, Cmin, AUCtau, AUClast, AUCinf, kel, half-life (t1/2), total body CLss, Vzss, Cmax ratio (Rac-Cmax), and AUC Ratio (Rac-AUC) - Population PK model development (NCM) from data of Phase 2a and Phase 2b data - Population and individual patient PK parameters estimation	—

Measure

Time frame

Further Efficacy: - Skin response as per Modified Severity-Weighted Assessment Tool (mSWAT) - Progression-free survival (PFS) - Duration of response (DOR) - Time to response (TTR) - Complete response rate (CRR) - Overall survival (OS) - Time to next (systemic) treatment (TTNT), Safety and Tolerability - Incidence, severity and nature of adverse events (AEs) - Changes from Baseline in vital signs, electrocardiogram (ECG), clinical laboratory values and Eastern Cooperative Oncology Group (ECOG) performance status (PS), PK: - PK parameters including: Cmax Tmax, Cmin, AUCtau, AUClast, AUCinf, kel, half-life (t1/2), total body CLss, Vzss, Cmax ratio (Rac-Cmax), and AUC Ratio (Rac-AUC) - Population PK model development (NCM) from data of Phase 2a and Phase 2b data - Population and individual patient PK parameters estimation

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Countries

France, Italy

Outcome results

None listed