A Phase I, Open-Label, Dose-Escalation Study of CC-11006 In Subjects With Low- or Intermediate-1 Risk Myelodysplastic Syndromes

NCT00458159 | Terminated Phase 1

• 1 other identifier: CC-11006-MDS-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 7

Brief Summary

A Phase I, Open-Label, Dose-Escalation Study of CC-11006 In Subjects With Low- or Intermediate-1 Risk Myelodysplastic Syndromes.

Conditions

Myelodysplastic Syndrome

Keywords

CC-11006; RA; MDS; Celgene; RCMD-RS; RARS; RAEB-1; Low-or Intermediate-1-Risk Myelodysplastic Syndrome (MDS)

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose of CC-11006

  2 cohorts

Secondary Outcomes (1)

• Safety of CC-11006-MDS-001

  Ongoing basis

Study Arms (1)

1

EXPERIMENTAL

Drug: CC-11006

Interventions

CC-11006 DRUG

Doses: 10mg, 15mg, 25mg, 35mg, \& 50mg, taken once daily, orally.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years.
• Able to understand and voluntarily sign an informed consent form.
• A diagnosis of de novo myelodysplastic syndrome (MDS) of at least 12 weeks duration, with one of the following subtypes (See WHO Classification and Criteria for Myelodysplastic Syndromes).
• Refractory anemia (RA)
• Refractory cytopenia with multilineage dysplasia (RCMD)
• Refractory anemia with ring sideroblasts (RARS)
• Refractory cytopenia with multilineage dysplasia and ringed sideroblasts (RCMD-RS)
• Refractory anemia with excess blasts (RAEB-1 \[5-9% blasts\])
• RAEB-2 (10%-19% blasts)
• MDS-Unclassified (MDS-U)
• MDS with chromosome 5q deletion (MDS 5q-)
• At least two hemoglobins \< 9 g/dL (untransfused) or transfusion-dependence defined as requiring at least 4 units of RBCs in the 56 days prior to Study Day 1 (start of CC-11006 treatment).
• Tried and failed one or more conventional first-line treatments for MDS with anemia including Revlimid®, recombinant erythropoietins, 5-azacitidine, decitibine or other associated therapies.
• More than 28 days (from Study Day 1) must have elapsed since any previous treatment (including Revlimid®) for MDS with anemia, other than transfusion(s).
• An ECOG Performance status of 0, 1 or 2 • Able to adhere to the study visit schedule and other protocol requirements.

You may not qualify if:

• Myelosclerosis (or myelofibrosis) occupying more than 30% of marrow space.
• Bone marrow blast ≥ 20 %.
• The following laboratory abnormalities:
• Absolute neutrophil count (ANC) \< 500 cells/L (0.5 x 109/L)
• Platelet count \< 50,000/L (50 x 109/L)
• Serum creatinine \> 2.0 mg/dL (177 mol/L)
• Serum SGOT/AST or SGPT/ALT \> 3.0 x upper limit of normal (ULN)
• Serum total bilirubin \> 2 x the ULN secondary to hemolysis in the absence of any known intrinsic liver disease
• A history of active tuberculosis requiring treatment within the previous 3 years (of Study Day 1) or opportunistic infections, including but not limited to evidence of active cytomegalovirus, active Pneumocystis carinii, or atypical mycobacterium infection, etc., or documented HIV infection, within the previous 6 months (of Study Day 1). Subjects with evidence of an old tuberculosis infection without documented adequate therapy are also excluded.
• A history of active non-hematopoietic malignancy, or a similar diagnosis within 3 years of Study Day 1 (except basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ).
• A history of venous thromboembolism.
• Clinically significant anemia due to factors such as iron, B12 or folate deficiencies, autoimmune or hereditary hemolysis or gastrointestinal bleeding (if a marrow aspirate is not evaluable for storage iron, transferrin saturation must be \> 20 % and serum ferritin not less than 50 ng/mL).
• Any clinically significant pulmonary, cardiac, vascular, endocrine, hepatic, neurological, gastrointestinal or genitourinary disease unrelated to underlying hematological disorder.
• Any life-threatening or active infection requiring parenteral antibiotic therapy.
• Chromosome abnormalities common to de novo acute myelogenous leukemia (AML), i.e., t(8:21), t(15;17), and inv (16).

Sponsors & Collaborators

• Celgene: lead

Study Sites (7)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202-5149, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

New York Presbyterian Hospital-Weill Cornell Medical College

New York, New York, 10021, United States

Location

Wake Forest University School of Medicine Bowman Gray Campus, Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1082, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Brandenburg N, et al. Venous thromboembolism in patients with myelodysplastic syndrome treated with lenalidomide: Incidence and risk factors. Presented at 2008 ASCO Annual Meeting, May 30-June 3, 2008, Chicago, IL. Abstract No. 7084.

  BACKGROUND

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Alan List, MD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2007
• First Posted: April 9, 2007
• Study Start: May 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

US (7)