Trial Outcomes & Findings for Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma (NCT NCT00117156)
NCT ID: NCT00117156
Last Updated: 2016-08-01
Results Overview
Objective response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on Cheson criteria (1999).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Assessed after three- and six-cycles of therapy.
Results posted on
2016-08-01
Participant Flow
Participant milestones
| Measure |
Fludarabine and Rituximab
Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts \> 10x10\^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Fludarabine and Rituximab
Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts \> 10x10\^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab
|
|---|---|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Trt for Pre-Exist Second Primary
|
1
|
Baseline Characteristics
Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Fludarabine and Rituximab
n=26 Participants
Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts \> 10x10\^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab
|
|---|---|
|
Age, Continuous
|
63.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
|
Histology
Nodal MZL
|
14 participants
n=5 Participants
|
|
Histology
MALT
|
8 participants
n=5 Participants
|
|
Histology
Splenic MZL
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed after three- and six-cycles of therapy.Population: The analysis dataset is comprised of all treated patients.
Objective response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on Cheson criteria (1999).
Outcome measures
| Measure |
Fludarabine and Rituximab
n=26 Participants
Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts \> 10x10\^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab
|
|---|---|
|
Objective Response Rate
|
.85 proportion of patients
Interval 0.65 to 0.96
|
SECONDARY outcome
Timeframe: Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 yearsPopulation: The analysis dataset is comprised of all treated patients.
3.1-year progression-free survival is the probability of patients remaining alive and progression-free at 3.1 years from study entry estimated using Kaplan-Meier methods. Disease progression was assessed per Cheson criteria (1999).
Outcome measures
| Measure |
Fludarabine and Rituximab
n=26 Participants
Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts \> 10x10\^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab
|
|---|---|
|
3.1-Year Progression-Free Survival
|
0.795 probability
Interval 0.634 to 0.956
|
SECONDARY outcome
Timeframe: Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 yearsPopulation: The analysis dataset is comprised of all treated patients.
3.1-year overall survival is the probability of patients remaining alive 3.1 years from study entry.
Outcome measures
| Measure |
Fludarabine and Rituximab
n=26 Participants
Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts \> 10x10\^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab
|
|---|---|
|
3.1-Year Overall Survival
|
0.874 probability
Interval 0.74 to 0.99
|
POST_HOC outcome
Timeframe: Assessed after therapy completion incidentally or at a minimum every 6 months for 2 years and then annually up to 4 years.Population: The analysis dataset is comprised of all treated patients.
Delayed bone marrow toxicity rate is the proportion of patients who experienced significant bone marrow toxicity defined as aplastic anemia or myelodysplastic syndromes (MDS) after completing therapy.
Outcome measures
| Measure |
Fludarabine and Rituximab
n=26 Participants
Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts \> 10x10\^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab
|
|---|---|
|
Delayed Bone Marrow Toxicity Rate
|
0.154 proportion of patients
Interval 0.043 to 0.349
|
POST_HOC outcome
Timeframe: Assessed after therapy completion incidentally or at a minimum every 6 months for 2 years and then annually up to 4 years.Population: The analysis dataset is comprised of all treated patients.
Delayed pneumonia toxicity rate is the proportion of patients who experienced significant pneumonia toxicity defined as nocardia or pneumocystis jiroveci after completing therapy.
Outcome measures
| Measure |
Fludarabine and Rituximab
n=26 Participants
Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts \> 10x10\^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab
|
|---|---|
|
Delayed Pneumonia Toxicity Rate
|
0.115 proportion of patients
Interval 0.024 to 0.301
|
Adverse Events
Fludarabine and Rituximab
Serious events: 20 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fludarabine and Rituximab
n=26 participants at risk
Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts \> 10x10\^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
2/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Fever w/o neutropenia
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Immune system disorders
Allergic reaction
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Leukocytes
|
42.3%
11/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Neutrophils
|
57.7%
15/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Platelets
|
19.2%
5/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Psychiatric disorders
Confusion
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
7.7%
2/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
Other adverse events
| Measure |
Fludarabine and Rituximab
n=26 participants at risk
Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts \> 10x10\^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Fludarabine
Rituximab
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
57.7%
15/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Cardiac disorders
Sinus tachycardia
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
2/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
19.2%
5/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Dysphagia
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Nausea
|
34.6%
9/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Fatigue
|
61.5%
16/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Fever w/o neutropenia
|
19.2%
5/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Rigors/chills
|
11.5%
3/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Constitutional, other
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Edema limb
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Immune system disorders
Allergic reaction
|
19.2%
5/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Infections and infestations
Infection Gr0-2 neut, upper airway
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Leukocytes
|
34.6%
9/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Neutrophils
|
15.4%
4/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Platelets
|
23.1%
6/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Alkaline phosphatase
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
ALT, SGPT
|
7.7%
2/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
AST, SGOT
|
7.7%
2/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Bilirubin
|
7.7%
2/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Creatinine
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Anorexia
|
11.5%
3/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic upper extr muscle weak
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Chest wall, pain
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
11.5%
3/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Dizziness
|
7.7%
2/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Neuropathy-sensory
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Neurologic-other
|
7.7%
2/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Head/headache
|
11.5%
3/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Psychiatric disorders
Insomnia
|
7.7%
2/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Psychiatric disorders
Anxiety
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
7.7%
2/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
11.5%
3/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Vascular disorders
Hypertension
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Vascular disorders
Hypotension
|
11.5%
3/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Vascular disorders
Flushing
|
3.8%
1/26 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
Additional Information
Jennifer R. Brown, MD, PhD
Dana-Farber Cancer Institute
Phone: (617) 632-3316
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place