Clinical Trials Logo

Clinical Trial Summary

This is a global, multicenter, open-label, repeat-dose, Phase 1/2 study consisting of a Dose Escalation Phase (Phase 1) and a Cohort Expansion Phase (Phase 2). In both phases, KB004 will be administered by IV infusion once weekly as part of a 21-day dosing cycle.


Clinical Trial Description

The purpose of Phase 1 is to determine a maximum tolerated dose (MTD) for KB004 when administered to subjects with hematologic malignancies who meet the entry criteria. Phase 1 has completed enrollment July of 2014, the recommended Phase 2 dose is 250 mg. AML 20 mg Cohort completed enrollment Dec 2014.

The purpose of Phase 2 is to characterize preliminary clinical activity. The Phase 2 portion of the study consists of two parts:

- Part A: Subjects with AML or MDS who meet the entry criteria

- Part B: Subjects with MF who meet the entry criteria ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01211691
Study type Interventional
Source KaloBios Pharmaceuticals
Contact
Status Suspended
Phase Phase 1/Phase 2
Start date September 2010
Completion date December 2016

See also
  Status Clinical Trial Phase
Completed NCT02626715 - Reduced-Intensity Conditioning (RIC) and Myeloablative Conditioning (MAC) for HSCT in AML/MDS Phase 2
Recruiting NCT02905552 - Myelodysplasic Syndromes and Risk Factors for Infection N/A
Completed NCT01772953 - Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT Phase 2
Active, not recruiting NCT06294275 - A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects Phase 1
Completed NCT00533416 - Safety of ON 01910.Na in Patients With Myelodysplasia Phase 1
Active, not recruiting NCT04401748 - Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome Phase 3
Recruiting NCT04608110 - A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome Phase 1
Recruiting NCT03613532 - Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN Phase 1
Withdrawn NCT03486353 - A Study of FF-10501-01 in Combination With Azacitidine in Patients With Myelodysplastic Syndrome Phase 2
Terminated NCT02259348 - Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation Phase 2
Terminated NCT01459159 - Study of (Telintra®) in Non-Del(5q) Myelodysplastic Syndrome Phase 2
Terminated NCT01422486 - Phase 2 Study of Telintra® in Deletion 5q Myelodysplastic Syndrome Phase 2
Terminated NCT00542828 - Rabbit Anti-thymocyte Globulin in the Treatment of Patients With Low to Intermediate-1 Risk Myelodysplastic Syndrome Phase 2
Completed NCT01685619 - AML-MDS Novel Prognostic Tests Clinical Study
Recruiting NCT01861093 - Safety Study of Cord Blood Units for Stem Cell Transplants Phase 2
Unknown status NCT01983761 - Study of ASC-101 in Patients With Hematologic Malignancies Who Receive Dual-cord Umbilical Cord Blood Transplantation Phase 1/Phase 2
Recruiting NCT01758042 - Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders N/A
Completed NCT01221857 - Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies Phase 1/Phase 2
Completed NCT01338337 - Study of Vidaza (Azacitidine) Versus Support Treatment in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 IPSS) Without the 5q Deletion and Transfusion Dependent Anaemia Phase 2
Terminated NCT01034657 - LBH589 Alone or in Combination With Erythropoietin Stimulating Agents (ESA) in Patients With Low or Int-1 Risk Myelodysplastic Syndromes (MDS) Phase 2