Trial Outcomes & Findings for Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma (NCT NCT00131937)

NCT ID: NCT00131937

Last Updated: 2015-09-03

Results Overview

Response was assessed using the criteria from International Workshop to Standardize Criteria for NHL (Cheson, 1999). OR=complete response(CR)+complete response/uncertain(CRu)+partial response(PR) CR: 1)Disappearance of clinical/radiographic evidence of disease (dz) and all dz-related B-symptoms; normalization of biochemical abnormalities attributed to NHL; 2)Lymph nodes and nodal masses regress to normal size; 3)Spleen, if enlarged before therapy, has decreased in size and is not palpable; 4)Complete resolution of lymphoma in bone marrow biopsy CRu: Meet criteria 1 and 3 above but with ≥1 of the followings. Residual dominant nodal mass \>1.5 cm in greatest diameter that has decreased by \>75%. Indeterminate bone marrow. PR: ≥50% decrease in SPD (sum of products of diameters) of 6 largest dominant nodes or nodal masses. No increase in size of liver or spleen. No unequivocal progression in nonmeasurable or nondominant sites. Splenic/hepatic nodules regress ≥50% in SPD. No new dz sites.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 14 participants
• Primary outcome timeframe: Assessed at the end of Cycle 2 and Cycle 6 (1 cycle = 28 days). Then every 3 months beginning Cycle 9 if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years.
• Results posted on: 2015-09-03

Participant Flow

Participant milestones

Measure	Treatment (Sorafenib) Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given orally
Overall Study STARTED	14
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	Treatment (Sorafenib) Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given orally
Overall Study Adverse Event	3
Overall Study Withdrawal by Subject	2
Overall Study Physician Decision	1
Overall Study Disease Progression	7
Overall Study Alternative therapy	1

Baseline Characteristics

Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Measure	Treatment (Sorafenib) n=14 Participants Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given orally
Sex: Female, Male Male	9 Participants n=5 Participants
Age, Continuous	69.5 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed at the end of Cycle 2 and Cycle 6 (1 cycle = 28 days). Then every 3 months beginning Cycle 9 if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years.

Response was assessed using the criteria from International Workshop to Standardize Criteria for NHL (Cheson, 1999). OR=complete response(CR)+complete response/uncertain(CRu)+partial response(PR) CR: 1)Disappearance of clinical/radiographic evidence of disease (dz) and all dz-related B-symptoms; normalization of biochemical abnormalities attributed to NHL; 2)Lymph nodes and nodal masses regress to normal size; 3)Spleen, if enlarged before therapy, has decreased in size and is not palpable; 4)Complete resolution of lymphoma in bone marrow biopsy CRu: Meet criteria 1 and 3 above but with ≥1 of the followings. Residual dominant nodal mass >1.5 cm in greatest diameter that has decreased by >75%. Indeterminate bone marrow.

PR: ≥50% decrease in SPD (sum of products of diameters) of 6 largest dominant nodes or nodal masses. No increase in size of liver or spleen. No unequivocal progression in nonmeasurable or nondominant sites. Splenic/hepatic nodules regress ≥50% in SPD. No new dz sites.

Outcome measures

Measure	Treatment (Sorafenib) n=14 Participants Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given orally
Overall Response (OR) Rate	0.07 Proportion of participants Interval 0.004 to 0.3

SECONDARY outcome

Timeframe: Assessed after month 2 and month 6, then every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years

PFS is defined as the time from randomization to the first of progression, relapse or death from any cause. Per criteria from International Workshop to Standardize Criteria for NHL (Cheson, 1999), progression (for patients who have not responded) and relapse (for patients who responded) are defined as:

1. Appearances of any new lesions/sites during or after therapy

2. Increase of ≥50% in the SPD from nadir measurement of all involved dominant lymph nodes and liver/spleen nodules or unequivocal progression in any nonmeasurable disease or nondominant site

3. Increase by ≥50% in greatest diameter from nadir measurement of any previously involved dominant node >1.0 cm in its short axis

Outcome measures

Measure	Treatment (Sorafenib) n=14 Participants Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given orally
Progression-Free Survival (PFS)	2 months Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Assessed after month 2 and month 6, then every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years.

Overall survival is defined as the time from study entry until death from any cause.

Outcome measures

Measure	Treatment (Sorafenib) n=14 Participants Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given orally
Overall Survival	9 months Interval 5.0 to 16.0

Adverse Events

Treatment (Sorafenib)

Serious events: 9 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Sorafenib) n=14 participants at risk All patients who received Sorafenib treatment.
Investigations White blood cell decreased	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Investigations Neutrophil count decreased	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Investigations Platelet count decreased	14.3% 2/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Vascular disorders Hypertension	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
General disorders Fatigue	35.7% 5/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Skin and subcutaneous tissue disorders Rash maculo-papular	21.4% 3/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndro	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Metabolism and nutrition disorders Dehydration	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Diarrhea	14.3% 2/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Nausea	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Metabolism and nutrition disorders Hyponatremia	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Nervous system disorders Dizziness	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment

Other adverse events

Measure	Treatment (Sorafenib) n=14 participants at risk All patients who received Sorafenib treatment.
Immune system disorders Allergic reaction	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Blood and lymphatic system disorders Anemia	35.7% 5/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Investigations Neutrophil count decreased	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Investigations Platelet count decreased	21.4% 3/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Vascular disorders Hypertension	50.0% 7/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
General disorders Fatigue	71.4% 10/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Investigations Weight loss	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Vascular disorders Flushing	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Skin and subcutaneous tissue disorders Alopecia	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Skin and subcutaneous tissue disorders Pruritus	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Skin and subcutaneous tissue disorders Rash maculo-papular	42.9% 6/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndro	21.4% 3/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders -	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Metabolism and nutrition disorders Anorexia	21.4% 3/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Constipation	14.3% 2/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Diarrhea	57.1% 8/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Flatulence	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Dyspepsia	21.4% 3/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Mucositis oral	14.3% 2/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Nausea	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Gastrointestinal disorders Gastrointestinal disorders - Other, spec	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Infections and infestations Urinary tract infection	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Infections and infestations Upper respiratory infection	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Investigations Alanine aminotransferase increased	28.6% 4/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Investigations Aspartate aminotransferase increased	35.7% 5/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Investigations Blood bilirubin increased	21.4% 3/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue di	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Nervous system disorders Dizziness	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Nervous system disorders Peripheral sensory neuropathy	14.3% 2/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Musculoskeletal and connective tissue disorders Pain in extremity	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Nervous system disorders Headache	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 2/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Musculoskeletal and connective tissue disorders Myalgia	14.3% 2/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Respiratory, thoracic and mediastinal disorders Dyspnea	7.1% 1/14 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment

Additional Information

Study Statistician

ECOG Statistical Office

Phone: 617-632-3012

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60