Trial Outcomes & Findings for Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT00634244)
NCT ID: NCT00634244
Last Updated: 2015-07-07
Results Overview
CR requires: 1. peripheral blood counts: neutrophil count ≥ 1.0 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, reduced hemoglobin concentration or hematocrit has no bearing on remission status, and leukemic blasts must not be present in the peripheral blood. 2. bone marrow aspirate and biopsy: maturation of all cell lines must be present, ≤ 5% blasts, auer rods must not be detectable. 3. extramedullary leukemia, such as central nervous system (CNS) or soft tissue involvement, must not be present. CRi requires that all criteria for complete remission be satisfied except patients can have residual neutropenia (\<1 x 10\^9/L) or thrombocytopenia (\<100 x 10\^9/L).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration.
Results posted on
2015-07-07
Participant Flow
This study was activated on October 16, 2008 and closed on August 2, 2013 with a total of 92 patients accrued. Duration the response evaluation after meeting the first stage accrual goal, Arm C did not meet the criteria to continue onto the second stage and was closed to accrual at that time.
Participant milestones
| Measure |
Arm A (Carboplatin and Topotecan Hydrochloride)
Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
carboplatin: Given IV
topotecan hydrochloride: Given IV
|
Arm B (Alvocidib, Mitoxantrone Hydrochloride, Cytarabine)
Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV
|
Arm C (Mitoxantrone Hydrochloride, Cytarabine, Sirolimus)
Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV
sirolimus: Given PO
etoposide: Given IV
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
37
|
20
|
|
Overall Study
Eligible and Treated
|
35
|
36
|
20
|
|
Overall Study
COMPLETED
|
34
|
24
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
13
|
0
|
Reasons for withdrawal
| Measure |
Arm A (Carboplatin and Topotecan Hydrochloride)
Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
carboplatin: Given IV
topotecan hydrochloride: Given IV
|
Arm B (Alvocidib, Mitoxantrone Hydrochloride, Cytarabine)
Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
alvocidib: Given IV
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV
|
Arm C (Mitoxantrone Hydrochloride, Cytarabine, Sirolimus)
Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
mitoxantrone hydrochloride: Given IV
cytarabine: Given IV
sirolimus: Given PO
etoposide: Given IV
|
|---|---|---|---|
|
Overall Study
Never started treatment
|
0
|
1
|
0
|
|
Overall Study
Death
|
1
|
6
|
0
|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Disease progression/relapse
|
0
|
1
|
0
|
|
Overall Study
Other complicating disease
|
0
|
1
|
0
|
Baseline Characteristics
Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Arm A (Carboplatin+Topotecan Hydrochloride)
n=35 Participants
Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
|
Arm B (Alvocidib+Cytarabine+Mitoxantrone)
n=36 Participants
Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
|
Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)
n=20 Participants
Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
62 years
n=7 Participants
|
52 years
n=5 Participants
|
57 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Disease status
< 6 months after 1st CR
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
6 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Disease status
6-12 mos after 1st CR
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
3 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Disease status
Refractory
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
10 participants
n=5 Participants
|
45 participants
n=4 Participants
|
|
Disease status
Unknown/Missing
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration.Population: Eligible and treated
CR requires: 1. peripheral blood counts: neutrophil count ≥ 1.0 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, reduced hemoglobin concentration or hematocrit has no bearing on remission status, and leukemic blasts must not be present in the peripheral blood. 2. bone marrow aspirate and biopsy: maturation of all cell lines must be present, ≤ 5% blasts, auer rods must not be detectable. 3. extramedullary leukemia, such as central nervous system (CNS) or soft tissue involvement, must not be present. CRi requires that all criteria for complete remission be satisfied except patients can have residual neutropenia (\<1 x 10\^9/L) or thrombocytopenia (\<100 x 10\^9/L).
Outcome measures
| Measure |
Arm A (Carboplatin+Topotecan Hydrochloride)
n=35 Participants
Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
|
Arm B (Alvocidib+Cytarabine+Mitoxantrone)
n=36 Participants
Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
|
Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)
n=20 Participants
Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
|
|---|---|---|---|
|
The Rate of Complete Remission (CR+CRi)
|
0.143 proportion of participants
Interval 0.071 to 0.347
|
0.278 proportion of participants
Interval 0.161 to 0.43
|
0.15 proportion of participants
Interval 0.042 to 0.344
|
SECONDARY outcome
Timeframe: Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration.Population: Eligible and treated
The definition of treatment failure will include: * ≥ 5% leukemic blasts at the time of pre-consolidation marrow * Death during/following induction chemotherapy (pre-consolidation) * Persisting marrow hypoplasia and pancytopenia for ≥ 2 months after chemotherapy * CNS or extramedullary disease at the time of pre-consolidation * Leukemia persistence after completion of induction treatment. Leukemia persistence is defined as greater than 10% residual blasts on marrow biopsy done 5-7 days after completion of induction chemotherapy
Outcome measures
| Measure |
Arm A (Carboplatin+Topotecan Hydrochloride)
n=35 Participants
Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
|
Arm B (Alvocidib+Cytarabine+Mitoxantrone)
n=36 Participants
Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
|
Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)
n=20 Participants
Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
|
|---|---|---|---|
|
The Rate of Treatment Failure
|
0.86 proportion of participants
Interval 0.72 to 0.94
|
0.72 proportion of participants
Interval 0.57 to 0.84
|
0.84 proportion of participants
Interval 0.64 to 0.96
|
Adverse Events
Arm A (Carboplatin+Topotecan Hydrochloride)
Serious events: 35 serious events
Other events: 35 other events
Deaths: 0 deaths
Arm B (Alvocidib+Cytarabine+Mitoxantrone)
Serious events: 36 serious events
Other events: 36 other events
Deaths: 0 deaths
Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)
Serious events: 20 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Carboplatin+Topotecan Hydrochloride)
n=35 participants at risk
Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
|
Arm B (Alvocidib+Cytarabine+Mitoxantrone)
n=36 participants at risk
Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
|
Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)
n=20 participants at risk
Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
62.9%
22/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
75.0%
27/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
55.0%
11/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.0%
7/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
22.2%
8/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
55.0%
11/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Atrial fibrillation
|
5.7%
2/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Death NOS
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
13.9%
5/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
10.0%
2/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Multi-organ failure
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
8.3%
3/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Pain
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
8.3%
3/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
5.7%
2/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
5.7%
2/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
22.2%
8/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dysphagia
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
11.4%
4/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
8.6%
3/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
11.1%
4/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
15.0%
3/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Typhlitis
|
5.7%
2/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
15.0%
3/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Catheter related infection
|
11.4%
4/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Enterocolitis infectious
|
5.7%
2/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Lung infection
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
22.2%
8/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Sepsis
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
19.4%
7/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Sinusitis
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Skin infection
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infections and infestations - Other
|
5.7%
2/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
25.0%
9/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Activated PTT prolonged
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
5.7%
2/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
11.1%
4/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
GGT increased
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphocyte count decreased
|
28.6%
10/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
44.4%
16/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
35.0%
7/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
97.1%
34/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
88.9%
32/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
95.0%
19/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
100.0%
35/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
100.0%
36/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
100.0%
20/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
100.0%
35/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
100.0%
36/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
100.0%
20/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
19.4%
7/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
4/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
19.4%
7/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.9%
8/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
25.0%
9/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.4%
4/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.6%
3/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
25.0%
9/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
10.0%
2/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
8.3%
3/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Metabolism and nutrition - Other
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Headache
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Syncope
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Blurred vision
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Cataract
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
10.0%
2/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
8.3%
3/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
13.9%
5/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Arm A (Carboplatin+Topotecan Hydrochloride)
n=35 participants at risk
Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
|
Arm B (Alvocidib+Cytarabine+Mitoxantrone)
n=36 participants at risk
Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
|
Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)
n=20 participants at risk
Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
97.1%
34/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
88.9%
32/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
100.0%
20/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
11.1%
4/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
10.0%
2/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Chills
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
27.8%
10/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
4/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema limbs
|
14.3%
5/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
22.2%
8/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
4/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
45.7%
16/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
33.3%
12/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
45.0%
9/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever
|
14.3%
5/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Pain
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.4%
4/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
16.7%
6/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
10.0%
2/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.7%
2/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
8.3%
3/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
8.3%
3/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
15.0%
3/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.4%
4/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
25.0%
9/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
4/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
8.6%
3/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
8.3%
3/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
8.6%
3/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
16.7%
6/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
10.0%
2/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
21/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
63.9%
23/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
65.0%
13/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dry mouth
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
8.3%
3/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
2/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
7/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
30.6%
11/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
35.0%
7/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
51.4%
18/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
50.0%
18/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
45.0%
9/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Oral pain
|
5.7%
2/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
10/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
27.8%
10/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
4/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
8.3%
3/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
14/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
33.3%
12/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
4/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
34.3%
12/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
38.9%
14/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
40.0%
8/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
42.9%
15/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
44.4%
16/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
25.0%
5/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
5.7%
2/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
38.9%
14/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
4/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
11.4%
4/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
25.0%
9/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
10.0%
2/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
ECG QT corrected interval prolonged
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
INR increased
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphocyte count decreased
|
8.6%
3/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
51.4%
18/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
36.1%
13/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
60.0%
12/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
74.3%
26/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
66.7%
24/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
85.0%
17/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
8.6%
3/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
8.3%
3/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
10.0%
2/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
68.6%
24/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
50.0%
18/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
80.0%
16/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Investigations - Other, specify
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
34.3%
12/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
22.2%
8/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
30.0%
6/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.6%
10/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
38.9%
14/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
40.0%
8/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.7%
2/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.7%
2/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
8.3%
3/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
8.3%
3/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.7%
9/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
30.6%
11/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
15.0%
3/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.7%
9/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
27.8%
10/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
25.0%
5/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.4%
4/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
25.0%
9/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
25.0%
5/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.7%
2/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
19.4%
7/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
4/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.1%
6/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
16.7%
6/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
10.0%
2/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.4%
4/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
13.9%
5/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
4/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Metabolism and nutrition - Other
|
11.4%
4/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
8.3%
3/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
10.0%
2/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
10.0%
2/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
8.3%
3/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dysgeusia
|
8.6%
3/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
11.1%
4/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
15.0%
3/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Headache
|
14.3%
5/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
13.9%
5/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
15.0%
3/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.6%
3/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
2.8%
1/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
8.6%
3/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
11.1%
4/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
10.0%
2/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.6%
3/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
8.3%
3/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
10.0%
2/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
16.7%
6/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.6%
3/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
8.3%
3/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.0%
1/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Urinary frequency
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hematoma
|
2.9%
1/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
5.6%
2/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
5.7%
2/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/20 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
25.7%
9/35 • Assessed every while on treatment and for 30 days after the end of treatment
|
16.7%
6/36 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
4/20 • Assessed every 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