Trial · NCT00446095
Efficacy and Safety Study of Fostamatinib Tablets to Treat B-cell Lymphoma
NCT00446095, Phase 1, Phase 2, Completed, Rigel Pharmaceuticals; results first posted 2014-12-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Fostamatinib Tablets to Treat B-cell Lymphoma. Trials, record NCT00446095. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00446095
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Fostamatinib Tablets to Treat B-cell Lymphoma
- NCT number
- NCT00446095
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 81 participants, actual
- Lead sponsor
- Rigel Pharmaceuticals
- Conditions
- Lymphoma
- Interventions
- fostamatinib
- First posted
- 2007-03-12
- Last updated
- 2016-09-19
- Results first posted
- 2014-12-18
- Limitations and caveats
- This is a small, non-randomized study. Comparisons between the 3 groups cannot be reliably made and should be interpreted with caution.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate as Assessed According to the"Revised Response Criteria for Malignant Lymphoma" (Cheson 2007). | Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response . (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days) | Proportion of patients with Complete Response (CR) or Partial Response (PR). Revised Response Criteria for Malignant Lymphoma categorises the response of the treatment of a patient's tumour to; CR: the disappearance of all evidence of disease; PR: ≥ 50% decrease in the sum of the perpendicular diameters (SPD) of the six largest dominant nodes plus no increase in the size of other nodes and no new sites of disease; Stable Disease (SD): less than a PR but not progressive disease; Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. Primary efficacy is based on Phase II patients only. |
| Primary | Clinical Benefit Rate as Assessed According to the "Revised Response Criteria for Malignant Lymphoma" (Cheson 2007). | Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days) | Proportion of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) |
| Secondary | Progression Free Survival (PFS) | Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days) | PFS: Time from date of first study drug administration to the date of progressive disease as assessed according to the "Revised Response Criteria for Malignant Lymphoma"(Cheson 2007) or the date of death due to any cause, whichever occurred first. |
| Secondary | Overall Survival (OS) | Overall survival is measured from the time of first administration of study drug to death. (Maximum duration of treatment 511days, Maximum duration of follow-up 812 Days) | OS: Time from date of first study drug administration to the date of death. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate as Assessed According to theRevised Response Criteria for Malignant Lymphoma (Cheson 2007). | Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response . (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days) | Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib. | Participants | NUMBER |
| PRIMARY | Clinical Benefit Rate as Assessed According to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007). | Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days) | Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib. | Participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days) | Phase II only as was not collected in Phase I. Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib. | Days | MEDIAN |
| SECONDARY | Overall Survival (OS) | Overall survival is measured from the time of first administration of study drug to death. (Maximum duration of treatment 511days, Maximum duration of follow-up 812 Days) | Phase II only as was not collected in Phase I. Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib. | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate as Assessed According to theRevised Response Criteria for Malignant Lymphoma (Cheson 2007). | Phase II: DLBCL | 5 | Participants | ||
| Overall Response Rate as Assessed According to theRevised Response Criteria for Malignant Lymphoma (Cheson 2007). | Phase II: 250mg R788 BID | 2 | Participants | ||
| Overall Response Rate as Assessed According to theRevised Response Criteria for Malignant Lymphoma (Cheson 2007). | Phase II: Other Lymphomas | 7 | Participants | ||
| Overall Response Rate as Assessed According to theRevised Response Criteria for Malignant Lymphoma (Cheson 2007). | Phase 1: 200mg and 250mg R788 BID | 1 | Participants | ||
| Clinical Benefit Rate as Assessed According to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007). | Phase II: DLBCL | 9 | Participants | ||
| Clinical Benefit Rate as Assessed According to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007). | Phase II: 250mg R788 BID | 13 | Participants | ||
| Clinical Benefit Rate as Assessed According to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007). | Phase II: Other Lymphomas | 14 | Participants | ||
| Clinical Benefit Rate as Assessed According to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007). | Phase 1: 200mg and 250mg R788 BID | 9 | Participants | ||
| Progression Free Survival (PFS) | Phase II: DLBCL | 83.0 | 95% Confidence Interval 41.0 to 137.0 | Days | |
| Progression Free Survival (PFS) | Phase II: 250mg R788 BID | 141.0 | 95% Confidence Interval 61.0 to 253.0 | Days |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase II (8 Weeks) | STARTED | Phase II: DLBCL | 23 | |
| Phase II (8 Weeks) | STARTED | Phase II: 250mg R788 BID | 21 | |
| Phase II (8 Weeks) | STARTED | Phase II: Other Lymphomas | 24 | |
| Phase II (8 Weeks) | STARTED | Phase I: 200mg R788 BID | 0 | |
| Phase II (8 Weeks) | STARTED | Phase I: 250mg R788 BID | 0 | |
| Phase II (8 Weeks) | COMPLETED | Phase II: DLBCL | 11 | |
| Phase II (8 Weeks) | COMPLETED | Phase II: 250mg R788 BID | 18 | |
| Phase II (8 Weeks) | COMPLETED | Phase II: Other Lymphomas | 21 | |
| Phase II (8 Weeks) | COMPLETED | Phase I: 200mg R788 BID | 0 | |
| Phase II (8 Weeks) | COMPLETED | Phase I: 250mg R788 BID | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events1,015
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Phase II: DLBCL | 5 | 23 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase II: 250mg R788 BID | 7 | 21 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase II: Other Lymphomas | 9 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase I: 200mg R788 BID | 4 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase I: 250mg R788 BID | 2 | 7 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase II: DLBCL | 7 | 23 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase II: 250mg R788 BID | 5 | 21 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase II: Other Lymphomas | 8 | 24 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase I: 200mg R788 BID | 4 | 6 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase I: 250mg R788 BID | 1 | 7 |
1 to 10 of 1,015Source ClinicalTrials.gov
See all 1,015 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase II: DLBCL | ||
| Total, all-cause mortality | Phase II: 250mg R788 BID | ||
| Total, all-cause mortality | Phase II: Other Lymphomas | ||
| Total, all-cause mortality | Phase I: 200mg R788 BID | ||
| Total, all-cause mortality | Phase I: 250mg R788 BID | ||
| Total, other adverse events | Phase II: DLBCL | 22 | 23 |
| Total, other adverse events | Phase II: 250mg R788 BID | 21 | 21 |
| Total, other adverse events | Phase II: Other Lymphomas | 24 | 24 |
| Total, other adverse events | Phase I: 200mg R788 BID | 6 | 6 |
| Total, other adverse events | Phase I: 250mg R788 BID | 6 | 7 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19965662 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00446095
GET https://conductscience.org/api/trials/v1/NCT00446095/flow?page=2