A Phase I Dose Escalation With Two Disease Specific Expansions, Multicenter, Open-label, Safety, Pharmacokinetic and Pharmacodynamic Study of LOR-253 in Patients With Relapsed or Refractory Hematologic Malignancies
Phase of Trial: Phase I
Latest Information Update: 08 Aug 2017
At a glance
- Drugs APTO 253 (Primary)
- Indications Acute myeloid leukaemia; Haematological malignancies; Lymphoma; Multiple myeloma; Myelodysplastic syndromes
- Focus Adverse reactions
- Sponsors Aptose Biosciences
- 08 Aug 2017 According to an Aptose Biosciences media release, the company is planning to submit findings from Preliminary root cause analyses studies to the FDA to reintroduced APTO-253 into the clinical trial.
- 14 Nov 2016 According to an Aptose Biosciences media release, the company's clinical team has identified and prepared multiple new clinical sites for the Phase 1b trial of APTO-253. The clinical sites, at major cancer research and treatment centers in the U.S., will be prepared to start the study as soon as the company resumes trial activities and re-initiates dosing and enrollment after the approval by FDA to do so.
- 13 Oct 2016 According to Aptose Biosciences media release, the company has received a response from the U.S. Food and Drug Administration (FDA) regarding the clinical hold of Phase 1b clinical trial of APTO-253 in patients with hematologic cancers requesting additional information and informing Aptose that the hold would not be removed until this information is submitted and reviewed.