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A Phase I Dose Escalation Study of Oral SB939 When Administered Thrice Weekly (Every Other Day) for 3 Weeks in a 4-week Cycle in Patients With Advanced Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors, Hematologic Malignancies, Myelodysplastic Syndrome

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Trial Information

A Phase I Dose Escalation Study of Oral SB939 When Administered Thrice Weekly (Every Other Day) for 3 Weeks in a 4-week Cycle in Patients With Advanced Malignancies

Inclusion Criteria


Inclusion criteria:

Arms A & B:

- Patients with solid tumors in Arm A and hematologic malignancies in Arm B that is
classified as intermediate 1 or greater according to the International Prognostic
Scoring System (IPSS) risk category for whom therapy is indicated;

- ECOG performance status (PS) 0-2;

- Patients must have adequate non-hematologic organ system function.

Arm C:

- Patients with MDS that is classified as intermediate 1 or greater according to the
International Prognostic Scoring System (IPSS) risk category for whom therapy is
indicated;

- Have not been treated with azacitidine and are a candidate for treatment with
azacitidine;

- ECOG performance status (PS) 0-2;

- Patients must have adequate non-hematologic organ system function.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the safety and tolerability of SB939, administered orally every other day 3 times a week for 3 consecutive weeks, repeated every 4 weeks, either alone (Arms A and B), or in combination with azacitidine therapy in (Arm C).

Outcome Time Frame:

Throughout the study

Safety Issue:

Yes

Principal Investigator

George Wilding, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

SB939-2006-001

NCT ID:

NCT00741234

Start Date:

April 2007

Completion Date:

March 2012

Related Keywords:

  • Solid Tumors
  • Hematologic Malignancies
  • Myelodysplastic Syndrome
  • SB939
  • Myelodysplastic Syndrome
  • Combination with azacitidine
  • Solid malignancies
  • Hematologic malignancies
  • HDAC inhibitor
  • Refractory to standard therapy
  • Neoplasms
  • Myelodysplastic Syndromes
  • Preleukemia
  • Hematologic Neoplasms

Name

Location
MD Anderson Cancer Center Houston, Texas  77030-4096
University of Wisconsin-Madison Madison, Wisconsin  53792