A Phase 1/2, Open-Label Clinical Study to Evaluate Safety and Efficacy of TP-0184 to Treat Anemia When Administered to Adult Patients with IPSS-R Low or Intermediate Risk of Myelodysplastic Syndromes

  • STATUS
    Recruiting
  • sponsor
    Sumitomo Dainippon
Updated on 18 June 2021

Summary

This is a Phase 1/2, open-label clinical study to evaluate preliminary safety and efficacy of TP-0184 to treat anemia when administered to adult patients with Revised International Prognostic Scoring System (IPSS-R) low or intermediate risk MDS.

The recommended Phase 2 dose (RP2D) will be determined by the maximum tolerated dose (MTD) or maximum administered dose (MAD) in the Phase 1 portion of the study.

Description


Details
Condition Myelodysplastic Syndromes (MDS), myelodysplastic syndromes
Clinical Study IdentifierTX275675
SponsorSumitomo Dainippon
Last Modified on18 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Documented diagnosis of lower risk MDS (IPSS-R Low, Intermediate) de novo or secondary
Relapse, Relapse, refractory/resistant, intolerant, or inadequate response to ESA treatment, as defined by the following
1.) Relapse according to IWG 2006
2.) Refractory/resistant – documented non-response or response that is no longer maintained to prior ESA-containing regimen, either as single agent or combination (e.g., with G-CSF)
3.) ESA regimen must have been either: a.) Recombinant human erythropoietin (rHu EPO) ≥ 40,000 IU/wk for at least 8 doses or equivalent; OR b.) Darbepoetin alpha ≥ 300 μg Q3W for at least 4 doses or equivalent
4.) Inadequate response – in the absence of transfusions support, patients under ESA treatment for at least 12 weeks that do not show a rise in hemoglobin of greater than equal to 1 g/dl
Adequate major organ functions on the basis of laboratory data within 28 days (4 weeks) before screening
ECOG Performance Status (PS) score ≤ 2
All previous therapies with ESAs, G-CSF and GM-CSF must be discontinued > 14 days before Cycle 1 Day 1 dosing

Exclusion Criteria

Presence of concomitant severe cardiovascular disease; CHF, myocardial infarction, angina and/ or uncontrolled cardiac arrhythmia as determined by the investigator within 6 months of study onset
Corrected QT interval of > 465 msec in men and > 480 msec in women
History of stroke, DVT, pulmonary or arterial embolism within 6 months prior to enrollment
Presence of clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding
Prior allogeneic or autologous stem cell transplant due to myeloid disease
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