Trial Outcomes & Findings for Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma (NCT NCT01381692)
NCT ID: NCT01381692
Last Updated: 2021-10-04
Results Overview
Temsirolimus in combination with bortezomib, rituximab, dexamethasone were to be escalated using a standard 3+3 design. The MTD was defined as the highest dose level at which no more than 0 in 3 or 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 28-day cycle of treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Assessed during cycle 1 (28 days)
Results posted on
2021-10-04
Participant Flow
All patients were accrued between July 20, 2011 and August 15, 2014.
Participant milestones
| Measure |
Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)
Patients receive temsirolimus IV at dose level 1 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)
Patients receive temsirolimus IV at dose level 2 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm C (Phase I: Temsirolimus Dose Level 3, Rituximab, Bortezomib, Dexamethasone)
Patients receive temsirolimus IV at dose level 3 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm D (Phase I: Temsirolimus Dose Level 4, Rituximab, Bortezomib, Dexamethasone)
Patients receive temsirolimus IV at dose level 4 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm E (Phase II: Rituximab, Bortezomib, Dexamethasone)
Patients receive rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only) and bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm F (Phase II: Temsirolimus, Rituximab, Bortezomib, Dexamethasone)
Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and rituximab, bortezomib, and dexamethasone as in arm E. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
6
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)
Patients receive temsirolimus IV at dose level 1 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)
Patients receive temsirolimus IV at dose level 2 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm C (Phase I: Temsirolimus Dose Level 3, Rituximab, Bortezomib, Dexamethasone)
Patients receive temsirolimus IV at dose level 3 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm D (Phase I: Temsirolimus Dose Level 4, Rituximab, Bortezomib, Dexamethasone)
Patients receive temsirolimus IV at dose level 4 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm E (Phase II: Rituximab, Bortezomib, Dexamethasone)
Patients receive rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only) and bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm F (Phase II: Temsirolimus, Rituximab, Bortezomib, Dexamethasone)
Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and rituximab, bortezomib, and dexamethasone as in arm E. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)
n=7 Participants
Patients receive temsirolimus IV at dose level 1 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)
n=2 Participants
Patients receive temsirolimus IV at dose level 2 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
72 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed during cycle 1 (28 days)Temsirolimus in combination with bortezomib, rituximab, dexamethasone were to be escalated using a standard 3+3 design. The MTD was defined as the highest dose level at which no more than 0 in 3 or 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 28-day cycle of treatment.
Outcome measures
| Measure |
Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)
n=7 Participants
Patients receive temsirolimus IV at dose level 1 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)
n=2 Participants
Patients receive temsirolimus IV at dose level 2 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Phase I: The Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Bortezomib, Rituximab and Dexamethasone
|
NA mg
The maximum tolerated dose (MTD) of temsirolimus was not determined because the study was terminated early due to slow accrual.
|
NA mg
The maximum tolerated dose (MTD) of temsirolimus was not determined because the study was terminated early due to slow accrual.
|
PRIMARY outcome
Timeframe: Assessed every 3 months if <2 years from study entry, every 6 months if 2-5 years from study entry, and annually if 6-10 yearsPopulation: No patients were enrolled in the phase II part of this study.
Progression-free survival is defined as the time from randomization to progression or death, whichever occurred first. Progression is evaluated based on Recommended Response Criteria for Waldenstrom's Macroglobulinemia. Progression is defined as at least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed by a second measurement at any time, as well as an absolute increase of the M-spike by 0.5g/dL, or progression of clinically significant findings due to disease, (i.e. anemia, thrombocytopenia, leukopenia, bulky adenopathy/organomegaly or symptoms of disease) or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis attributable to WM.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed every 3 months if <2 years from study entry, every 6 months if 2-5 years from study entry, and annually if 6-10 yearsPopulation: No patients were enrolled in the phase II part of this study.
Time to progression is defined as the time from randomization to disease progression. Progression is evaluated based on Recommended Response Criteria for Waldenstrom's Macroglobulinemia. Progression is defined as at least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed by a second measurement at any time, as well as an absolute increase of the M-spike by 0.5g/dL, or progression of clinically significant findings due to disease, (i.e. anemia, thrombocytopenia, leukopenia, bulky adenopathy/organomegaly or symptoms of disease) or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis attributable to WM.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at cycle 6Population: No patients were enrolled in the phase II part of this study.
Response is evaluated based on Recommended Response Criteria for Waldenstrom's Macroglobulinemia (WM). Major response is defined as complete response (CR), near CR (nCR), very good partial remission (VGPR), or partial response (PR). CR: Disappearance of monoclonal protein by immmunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly, or signs or symptoms attributable to WM Near CR (nCR): As for CR except that immunofixation is still positive VGPR: At least 90% reduction of serum monoclonal protein using serum protein electrophoresis (SPEP) PR: At least 50% reduction of serum monoclonal concentration on protein electrophoresis and at least a decrease in adenopathy/organomegaly (confirmed by original mode of imaging). No new signs or symptoms of active disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at cycle 6Population: No patients were enrolled in the phase II part of this study.
Response is evaluated based on Recommended Response Criteria for Waldenstrom's Macroglobulinemia (WM). Minor response is defined as achieving minor response (MR) or better (including complete response \[CR\], near CR (nCR), very good partial remission \[VGPR\], partial response \[PR\] and MR). CR: Disappearance of monoclonal protein by immmunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly, or signs or symptoms attributable to WM nCR: As CR except that immunofixation is still positive VGPR: At least 90% reduction of serum monoclonal protein using serum protein electrophoresis PR: At least 50% reduction of serum monoclonal concentration on protein electrophoresis and at least a decrease in adenopathy/organomegaly (confirmed by original mode of imaging). No new signs or symptoms of active disease. MR: At least 25% but less than 50% reduction of serum monoclonal protein and no new signs or symptoms of active disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed every 3 months if <2 years of study entry, every 6 months if 2-5 years of study entry, and annually if 6-10 yearsPopulation: No patients were enrolled in the phase II part of this study.
Time to response is defined as the time from randomization to documentation of response. Response is evaluated based on Recommended Response Criteria for Waldenstrom's Macroglobulinemia (WM). Response is defined as complete response (CR), near CR (nCR), very good partial remission (VGPR), partial response (PR) or minor response (MR). CR: Disappearance of monoclonal protein by immmunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly, or signs or symptoms attributable to WM nCR: As CR except that immunofixation is still positive VGPR: \>=90% reduction of serum monoclonal protein using serum protein electrophoresis PR: \>=50% reduction of serum monoclonal concentration on protein electrophoresis and at least a decrease in adenopathy/organomegaly (confirmed by original mode of imaging). No new signs or symptoms of active disease. MR: \>=25% but \<50% reduction of serum monoclonal protein. No new signs or symptoms of active disease
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed every 3 months if <2 years of study entry, every 6 months if 2-5 years of study entry, and annually if 6-10 yearsPopulation: No patients were enrolled in the phase II part of this study.
Duration of response is defined as the time from documentation of response to disease progression. Response evaluation will be based on the Recommended Response Criteria for Waldenstrom's Macroglobulinemia (WM). Response is defined as complete response (CR), near CR (nCR), very good partial remission (VGPR), partial response (PR) or minor response (MR). Progression is defined as at least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed by a second measurement at any time, as well as an absolute increase of the M-spike by 0.5g/dL, or progression of clinically significant findings due to disease, or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis attributable to WM.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed every 3 months if <2 years of study entry, every 6 months if 2-5 years of study entry, and annually if 6-10 yearsPopulation: No patients were enrolled in the phase II part of this study.
Time to next therapy is defined as duration from the end of protocol treatment to the initiation of next therapy, censored at date last known alive without initiation of next therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed every 3 months if <2 years of study entry, every 6 months if 2-5 years of study entry, and annually if 6-10 yearsPopulation: No patients were enrolled in the phase II part of this study.
Overall survival is defined as the time from randomization to date of death or date last known alive.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)
Serious events: 7 serious events
Other events: 7 other events
Deaths: 1 deaths
Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)
n=7 participants at risk
Patients receive temsirolimus IV at dose level 1 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)
n=2 participants at risk
Patients receive temsirolimus IV at dose level 2 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
3/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphocyte count decreased
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
42.9%
3/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
42.9%
3/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
28.6%
2/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
28.6%
2/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)
n=7 participants at risk
Patients receive temsirolimus IV at dose level 1 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)
n=2 participants at risk
Patients receive temsirolimus IV at dose level 2 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
71.4%
5/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema limbs
|
42.9%
3/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
71.4%
5/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Localized edema
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Pain
|
28.6%
2/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.6%
2/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
28.6%
2/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
71.4%
5/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
42.9%
3/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Lung infection
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Nail infection
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Sinusitis
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Skin infection
|
0.00%
0/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Upper respiratory infection
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Injury, poisoning and procedural complications
Bruising
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
42.9%
3/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
42.9%
3/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Cholesterol high
|
57.1%
4/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphocyte count decreased
|
42.9%
3/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
100.0%
7/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
85.7%
6/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
100.0%
7/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Investigations - Other, specify
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
2/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
57.1%
4/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
2/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
71.4%
5/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Flushing
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hot flashes
|
14.3%
1/7 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60