Study of PTC299 (Emvododstat) in Relapsed/Refractory Acute Leukemias

Status Terminated

Clinical Trial Summary

This is an open-label, non-randomized, Phase 1b study to evaluate the safety, pharmacokinetics (PK) profiles, and preliminary evidence of antitumor activity of PTC299 and the metabolite, O-desmethyl PTC299, in participants with relapsed/refractory acute myeloid leukemia (AML) who have exhausted standard available therapies known to provide clinical benefit. The study is designed as a series of cohort-based dose escalations. For each cohort, a minimum of 3 evaluable participants with PK and safety data will be assessed. Additional participants will be recruited if additional PK data are needed to assess mean exposure based on the observed variability.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03761069
Study type	Interventional
Source	PTC Therapeutics
Contact
Status	Terminated
Phase	Phase 1
Start date	October 29, 2018
Completion date	December 28, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05319587` - Study of Liposomal Annamycin in Combination With Cytarabine for the Treatment of Subjects With Acute Myeloid Leukemia (AML)	Phase 1/Phase 2
Active, not recruiting	`NCT04090736` - Study to Compare Azacitidine Plus Pevonedistat Versus Azacitidine in Patients With Acute Myeloid Leukemia Not Eligible for Standard Chemotherapy	Phase 3
Completed	`NCT01617226` - Randomised Study of Azacitidine Versus Azacitidine With Vorinostat in Patients With AML or High Risk MDS	Phase 2
Terminated	`NCT00916045` - Pilot Study of Unrelated Cord Blood Transplantation	Phase 2
Terminated	`NCT00957580` - Trial of Pimasertib in Hematological Malignancies	Phase 2
Completed	`NCT00640796` - Pilot Study of Expanded, Donor Natural Killer Cell Infusions for Refractory Non-B Lineage Hematologic Malignancies and Solid Tumors	Phase 1
Completed	`NCT00458250` - Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H	Phase 1
Active, not recruiting	`NCT05424380` - A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS	Phase 1
Completed	`NCT01690624` - BI 836858 Dose Escalation in Patients With Refractory or Relapsed Acute Myeloid Leukemia and in Patients in Complete Remission With High Risk to Relapse	Phase 1
Recruiting	`NCT05471700` - Single Arm Study of Azacitidine and Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients	Phase 1/Phase 2
Not yet recruiting	`NCT05016063` - Dual CD33-CLL1-CAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia	Early Phase 1
Not yet recruiting	`NCT04450784` - ObServatory Children Acute RElated Therapy Leukemia
Recruiting	`NCT04265963` - CD123-Targeted CAR-T Cell Therapy for Relapsed/Refractory Acute Myeloid Leukemia	Phase 1/Phase 2
Terminated	`NCT04968860` - Oral Health Condition and Quality of Life in Children With Leukemia
Recruiting	`NCT03793517` - Decitabine Plus mBU/CY for High Risk Acute Leukemia With MRD Pre-HSCT	Phase 2/Phase 3
Terminated	`NCT02841540` - A Study of H3B-8800 (RVT-2001) in Participants With Lower Risk Myelodysplastic Syndromes	Phase 1
Recruiting	`NCT05453903` - A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies	Phase 1
Completed	`NCT03720366` - A Study of Perpetrator Drug Interactions of Enasidenib in AML Patients	Phase 1
Withdrawn	`NCT04230564` - Acute Myeloid Leukemia Real World Treatment Patterns
Completed	`NCT01835587` - Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).	Phase 1/Phase 2