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Clinical Trial 19430

Cancer Type: Malignant Hematology
Interventions:TEW-7197

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Rami Komrokji

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Phase 1/2 Study of TEW-7197 Monotherapy in Patients with Low or Intermediate Myelodysplastic Syndromes (MDS)

Summary

The goal of this study is to evaluate the safety and efficacy of an investigational drug called TEW-7197 when it is given to people with Myelodysplastic Syndromes (MDS). TEW-7197 is also currently being tested in other clinical research studies for other malignancies. TEW-7197 is being studied as a new potential anticancer drug and as a potential treatment for myelodysplasia. It is thought that TEW-7197 exerts its anticancer effect by interfering with critical cellular signaling pathways and preventing the tumor cells from dividing and growing.

Objective

Primary Objective: The primary objectives of this phase 1/2 trial are to evaluate the safety and tolerability of TEW-7197 monotherapy in a dose -escalation phase by defining the maximum tolerable dose (MTD) and determining 2 doses to be used in the second, proof-of-concept phase of the study to determine the best hematologic improvement (HI) maintained for 8 weeks and evaluate the efficacy and safety of TEW-7197 monotherapy in subjects with Myelodysplastic Syndromes (MDS). Secondary Objective(s) The secondary objectives of the study are as follows: To characterize the PK profile of TEW-7197 in patients with MDS. To document the time to best HI. To document the duration of best HI. To assess the effect on transfusion dependency for red blood cells and platelets. To evaluate the frequency of bone marrow response (CR+PR) and cytogenetic response. To determine changes of TGF-B-associated signaling-related biomarkers (for example, pSMAD2 inhibition in bone marrow). To evaluate the relationship between mutations and response. To evaluate the relationship between various stem and progenitor alterations and response. To evaluate the quality of life parameters experienced by patients with MDS. To summarize vital signs, physical findings, adverse events, laboratory findings, and tumor imaging evaluation results.

Inclusion Criteria

  • Males or females ≥ 18 years of age.
  • Able to give written informed consent.
  • Have a documented diagnosis of myelodysplastic syndrome (MDS) according to World Health Organization (WHO) criteria.
  • Patients with del(5q) who should have failed or not be a candidate for approved therapy (Lenalidomide) prior to enrolling on this study.
  • Meet accepted standard criteria for treatment and have failed or not candidates for standard, accepted treatments.
  • Sufficient hepatic and renal function.
  • Able to swallow tablets.
  • Willing and able to comply with scheduled visits, treatment plans, laboratory tests and procedures.
  • Females of childbearing potential must have a negative serum pregnancy test within 7 days of the first administration of study drug.
  • Females of child bearing potential who are willing to avoid the pregnancy during the duration of the study and for 30 days following the last dose of study drug. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
  • Additional criteria may apply.

  • Exclusion Criteria

  • Have received treatment within the last 28 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Have moderate or severe cardiac disease.
  • Have documented iron, B12, folate deficiency as determined by the investigator.
  • Females who are breastfeeding, or intend to breastfeed during the duration of the study and for 30 days following the last dose of study drug.
  • Any other serious medical condition which in the Investigator's opinion would preclude safe participation in the study.
  • Known history of difficulty swallowing, malabsorption or other conditions that may reduce absorption of the product.
  • Active infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus.
  • Active infection requiring systemic antibiotic therapy.
  • Are currently using or planning to use drugs which are exclusively or primarily eliminated by cytochrome P-450 isozyme 3A4.
  • Additional criteria may apply.