Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma

NCT00798096 | Completed Phase 2 Results DMC

• 2 other identifiers: D4300C00024C-935788-017
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 10

Brief Summary

Patients meeting specific inclusion and exclusion criteria will be enrolled in two stages, 19 patients in Stage 1 and 36 patients in Stage 2. Stage 2 will enroll if 4 or more patients exhibit a response at Week 8 or later in the study. All enrolled patients will be treated with Fostamatinib Disodium until disease progression. Efficacy will be assessed by tumor measurements using CT and PET (when indicated) scans and physical exam at baseline, and scans and physical exam of all disease-involved areas every 8 weeks until progression. Safety will be assessed by periodic physical exams, clinical laboratory studies, and adverse events. All patients will have a follow-up visit 30 days following last study drug treatment. Blood samples for PK assessment will be obtained from all patients enrolled in Stage 1 at protocol defined intervals.

Conditions

T Cell Lymphoma

Keywords

T Cell Lymphoma; Lymphoma

Outcome Measures

Primary Outcomes (1)

• The Primary Efficacy Endpoint for This Study is Overall Regressive Response Rate (ORRR): Proportion of Patients With a Best Response of Complete Response (CR), Partial Response (PR), or Regressive Stable Disease (RSD).

  Overall regressive response rate (ORRR) is the proportion of patients with a best response of Complete Response (CR), Partial Response (PR) (per Cheson 2007), or Regressive Stable Disease (RSD) defined as regressive disease that does not meet the criteria for partial response.

  Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)

Secondary Outcomes (3)

• Clinical Benefit Rate is the Proportion of Patients With Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).

  Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)

• Overall Response Rate (ORR) is the Proportion of Patients With a Best Response of Complete Response (CR) or Partial Response (PR).

  Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)

• Duration of Overall Response is the Time From First Documentation of Complete or Partial Response, Whichever Occurs Earlier, to Discontinuation of Study Drug.

  Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)

Study Arms (1)

1

EXPERIMENTAL

Drug: Fostamatinib Disodium

Interventions

Fostamatinib Disodium DRUG

200 mg PO BID

Also known as: Code Designation: R935788 Sodium Hexahydrate, USAN Name: Fostamatinib Disodium, CAS No.: 914295-16-2

1

Eligibility Criteria

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

You may qualify if:

• Patients must give written informed consent to participate in this study by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study.
• Males and females, 18 years of age or older.
• Patients must have histologically proven T-cell lymphoma (TCL).
• Patients must have documented disease progression after receiving at least one prior therapeutic regimen and must be patients for whom no known curative therapy exists.

You may not qualify if:

• Patient has a history of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study.
• Has a B-cell lymphoma, primary CNS lymphoma, or known lymphomatous involvement of the CNS, or any other NK/T-cell leukemia/lymphoma.
• Has uncontrolled or poorly controlled hypertension.
• Has had recent (within 1 month prior to Day 1) serious surgery or uncontrolled infectious disease.
• Has any concurrent malignancy requiring treatment.
• Has a known positive test for Hepatitis B surface Ag, Hepatitis C, or HIV.
• Has laboratory abnormalities.
• Has difficulty swallowing or malabsorption.
• Has an ECOG performance status \> 2.
• Has not recovered from adverse effects related to last prior therapy for lymphoma.
• Has had an allotransplantation within 90 days prior to Day 1 of treatment.
• Has been treated with a CYP3A4 inducer/inhibitor within 3 days prior to Day 1 of treatment or is expected to require treatment with CYP3A4 inducer/inhibitor during the course of the study.
• Has received systemic steroids at a dose greater than the equivalent of 10 mg/day of prednisone within 7 days prior to Day 1 of treatment.
• Has received any other investigational therapy within 5 half-lives of the agent or 2 weeks of Day 1 of treatment, whichever is longer.
• Is a female of childbearing potential unless menopausal, surgically sterile, or willing to use an effective method of birth control, (oral contraceptive, mechanical barrier, long-acting hormonal agent), during the study and for 30 days thereafter.

Sponsors & Collaborators

• Rigel Pharmaceuticals: lead

Study Sites (10)

Research Site

San Francisco, California, 94143, United States

Location

Research Site

Stanford, California, 94305, United States

Location

Research Site

Atlanta, Georgia, 30322, United States

Location

Research Site

Boston, Massachusetts, 02115, United States

Location

Research Site

Rochester, Minnesota, 55905, United States

Location

Research Site

Omaha, Nebraska, 68198, United States

Location

Research Site

New York, New York, 10021, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Research Site

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Research Site

Toronto, Ontario, M5G 2M9, Canada

Location

Related Links

• D4300C00024 Clinical Study Report

MeSH Terms

Conditions

Lymphoma, T-Cell; Lymphoma

Interventions

fostamatinib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

This is a small, non-randomized study.

Results Point of Contact

• Title: Anne-Marie Duliege, MD
• Organization: Rigel

clinicaltrials@rigel.com

650-624-1100

Study Officials

• Jeffrey Skolnik, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 25, 2008
• Study Start: March 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: September 19, 2016
• Results First Posted: June 12, 2014

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); CA (2)