There are 2 clinical trials
This study employs a 1:1 randomization of patients to receive romidepsin alone verses romidepsin plus pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The primary objectives will be to identify a 75% improvement in progression free survival (PFS) among patients receiving the combination compared to single agent romidepsin.
There were 3 dose-limiting toxicities (DLTs) in cohort 4 (pralatrexate 20mg/m2 & romidepsin 12mg/m2given weekly x 2 Q21D) consisting of 2 Grade 3 oral mucositis and 1 Grade 4 sepsis. --- Q21D ---
Description: Compare the progression free survival (PFS) in patients with R/R PTCL treated with romidepsin versus the combination of romidepsin plus pralatrexate.
Measure: Progression Free Survival Time: up to 3 yearsDescription: Contrast the complete response rate (CR) for patients treated with romidepsin or romidepsin plus pralatrexate.
Measure: Complete Response (CR) Time: up to 3 yearsDescription: Contrast the duration of response (DOR) for patients treated with romidepsin or romidepsin plus pralatrexate.
Measure: Duration of response (DOR) Time: up to 3 yearsDescription: Contrast the overall survival (OS)for patients treated with romidepsin or romidepsin plus pralatrexate.
Measure: Overall survival (OS) Time: up to 3 yearsDescription: Contrast the overall response rate (ORR) for patients treated with romidepsin or romidepsin plus pralatrexate.
Measure: Overall response rate (ORR) Time: up to 3 yearsDescription: TTP measured for patients with relapsed or refractory PTCL treated with romidepsin or romidepsin plus pralatrexate.
Measure: Time to Treatment Progression (TTP) Time: up to 3 yearsDescription: TTR measured for patients with relapsed or refractory PTCL treated with romidepsin or romidepsin plus pralatrexate.
Measure: Time to Relapse (TTR) Time: up to 3 yearsDescription: Describe the maximum number of cycles and planned dose intensity of all drugs in both arms in patients with R/R PTCL treated with romidepsin or romidepsin plus pralatrexate.
Measure: Maximum Number of Treatment Cycles Time: Up to 6 monthsST1968 is a novel camptothecin derivative which interacts with topoisomerase I-DNA complex, inducing S-Phase specific cytotoxicity. It is endowed with a potent antitumor activity and an increased Therapeutic Index with respect to the clinically used analogues (i.e.irinotecan and topotecan) in some xenograft models (ovary, colon, head & neck, cervix). Anti-tumor activity has been also noted in platinum resistant ovarian cell xenografts and in topoisomerase I mutant prostate cell lines. The acceptable toxicity profile in animals and the activity in camptothecin-resistant cell lines make ST1968 a good candidate for clinical trials.
A starting dose of 1.5mg/m2 given as a flat dose of 2.5mg is defined, given once on Day 1, Day 8 every 21 Days (D1, D8 Q21D schedule), over 2 h. --- Q21D ---
Starting dose for the Day 1 every 21 Days (D1 Q21D schedule) has to be determined from the MTD of D1, D8 Q21D schedule. --- Q21D ---
Starting dose for the Day 1 every 21 Days (D1 Q21D schedule) has to be determined from the MTD of D1, D8 Q21D schedule. --- Q21D --- --- Q21D ---
Description: 2/6 patients with a Dose Limiting Toxicity (DLT) at the first cycle (21 days)
Measure: Maximum Tolerated Dose (MTD) of ST1968 given I.V. once every week for 2 consecutive weeks every 3 weeks and MTD of ST1968 given I.V. once every 3 weeks Time: 21 daysDescription: safety assessments (routine physical examinations and laboratory evaluations) and severity of adverse events based on the NCI-Common Terminology Criteria for Adverse Events V. 3.0 (NCI-CTCAE)
Measure: Adverse events, physical examination and laboratory tests (hematology and biochemistry) as a measure of safety and tolerability Time: 21 days of each cycle of therapyDescription: objective tumor response based on RECIST criteria
Measure: Tumor response Time: 4 weeksDescription: full blood and urine PK
Measure: Tmax, Cmax, AUC0-24, AUC-last, T1/2,CL Time: 21 days