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Completed

NCT Number: NCT00741234

A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine

This is an open label, dose escalation study with 3 arms (Arms A, B, and C). Arm A will assess the safety and tolerability of escalating doses of SB939 in cohorts of patients with advanced solid tumors. Arm B will assess the safety and tolerability of escalating doses in cohorts of patients with advanced hematologic malignancies. Arm C will assess the safety and tolerability of SB939 in combination with standard azacitidine therapy.

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Key information

Conditions

Solid Tumors Bone Marrow Diseases Hematologic Diseases Hematologic Malignancies Hematologic Neoplasms Hemic and Lymphatic Diseases Myelodysplastic Syndrome Myelodysplastic Syndromes Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center, Singapore

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB939

Drug

SB939 taken orally in a 4-week cycle.

Azacitidine

Drug

Azacitidine taken orally with SB939 in a 4-week cycle

Other names: Vidaza

Primary outcomes

  1. 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).

    Time frame: Throughout the study

Secondary outcomes

  1. To establish the maximum tolerated dose and a recommended phase II dose of SB939 as a single agent when administered every other day 3 times a week for 3 consecutive weeks, repeated every 4 weeks

    Time frame: Throughout the study

  2. To determine the dose limiting toxicities of SB939

    Time frame: Throughout the study

  3. To determine the pharmacokinetic profile of SB939

    Time frame: Throughout the study

  4. To assess histone acetylation in PBMC and other biomarkers

    Time frame: Throughout the study

  5. To document anti-tumor activity

    Time frame: Throughout the study

Sponsors and collaborators

Lead sponsor

S*BIO

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Aug 26, 2008
Registry last updated
Apr 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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