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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 in Solid Tumors in Japan

NCT00503477

Advanced Solid Tumor

COMPLETED PHASE1

Azacitidine Plus Phenylbutyrate in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Treatment

NCT00005639

Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Phase I, Open-Label, Dose-Escalation Study of AZD4877 in Solid Tumors

NCT00389389

Neoplasms

COMPLETED PHASE1

An Open-Label, Dose-Escalation Study of AZD2461

NCT01247168

Refractory Solid Tumors Cancer Tumor

COMPLETED PHASE1

AZD5153 in Patients With Relapsed or Refractory Solid Tumors, Including Lymphomas

NCT03205176

Malignant Solid Tumors Lymphoma Ovarian Cancer +3 more

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Tumors Hematologic Malignancies Myelodysplastic Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Advanced solid tumors

Group Type EXPERIMENTAL

SB939

Intervention Type DRUG

SB939 taken orally in a 4-week cycle.

B

Advanced hematologic malignancies

Group Type EXPERIMENTAL

SB939

Intervention Type DRUG

SB939 taken orally in a 4-week cycle.

C

Myelodysplastic Syndrome

Group Type EXPERIMENTAL

SB939

Intervention Type DRUG

SB939 taken orally in a 4-week cycle.

Azacitidine

Intervention Type DRUG

Azacitidine taken orally with SB939 in a 4-week cycle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SB939

SB939 taken orally in a 4-week cycle.

Intervention Type DRUG

Azacitidine

Azacitidine taken orally with SB939 in a 4-week cycle

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vidaza

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No