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Phase 1/2a Study of BAL101553 as 48-hour Infusions in Patients With Advanced Solid Tumors or Recurrent Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02895360
Recruitment Status : Completed
First Posted : September 9, 2016
Results First Posted : October 11, 2021
Last Update Posted : December 1, 2022
Sponsor:
Information provided by (Responsible Party):
Basilea Pharmaceutica

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms
Interventions Drug: BAL101553
Drug: BAL101553 at MTD
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase 1 - 30 mg/m² Cohort Phase 1 - 45 mg/m² Cohort Phase 1 - 70 mg/m² Cohort Phase 1 - 90 mg/m² Cohort Phase 2a - Ovarian Cancer Cohort Phase 2a - Recurrent Glioblastoma Cohort
Hide Arm/Group Description BAL101553 30 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 30 mg/m². BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m². BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m². BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².

BAL101553 at 70 mg/m² (MTD)

BAL101553 as 48-hour infusion on day 1, 8, and 15 of each 28-day cycle

BAL101553 at 70 mg/m² (MTD)

BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
Period Title: Phase 1 - 30 mg/m² Cohort
Started 4 0 0 0 0 0
Completed 0 0 0 0 0 0
Not Completed 4 0 0 0 0 0
Reason Not Completed
Progressive disease             4             0             0             0             0             0
Period Title: Phase 1 - 45 mg/m² Cohort
Started 0 3 0 0 0 0
Completed 0 0 0 0 0 0
Not Completed 0 3 0 0 0 0
Reason Not Completed
Progressive disease             0             3             0             0             0             0
Period Title: Phase 1 - 70 mg/m² Cohort
Started 0 0 9 0 0 0
Completed 0 0 0 0 0 0
Not Completed 0 0 9 0 0 0
Reason Not Completed
Adverse Event             0             0             2             0             0             0
Progressive disease             0             0             7             0             0             0
Period Title: Phase 1 - 90 mg/m² Cohort
Started 0 0 0 4 0 0
Completed 0 0 0 0 0 0
Not Completed 0 0 0 4 0 0
Reason Not Completed
Progressive disease             0             0             0             4             0             0
Period Title: Phase 2a
Started 0 0 0 0 11 12
Completed 0 0 0 0 0 0
Not Completed 0 0 0 0 11 12
Reason Not Completed
Adverse Event             0             0             0             0             0             1
Progressive disease             0             0             0             0             11             11
Arm/Group Title 30 mg/m² Cohort 45 mg/m² Cohort 70 mg/m² Cohort 90 mg/m² Cohort Phase 2a - Ovarian Cancer Cohort Phase 2a - Recurrent Glioblastoma Cohort Total
Hide Arm/Group Description BAL101553 30 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 30 mg/m². BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m². BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m². BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m². BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle Total of all reporting groups
Overall Number of Baseline Participants 4 3 9 4 11 12 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 9 participants 4 participants 11 participants 12 participants 43 participants
54.3  (3.30) 61.0  (0) 59.6  (10.53) 63.0  (7.26) 64.7  (8.78) 59.3  (7.45) 60.7  (8.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 9 participants 4 participants 11 participants 12 participants 43 participants
Female
2
  50.0%
2
  66.7%
6
  66.7%
3
  75.0%
11
 100.0%
3
  25.0%
27
  62.8%
Male
2
  50.0%
1
  33.3%
3
  33.3%
1
  25.0%
0
   0.0%
9
  75.0%
16
  37.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 9 participants 4 participants 11 participants 12 participants 43 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
4
 100.0%
3
 100.0%
9
 100.0%
4
 100.0%
11
 100.0%
12
 100.0%
43
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Switzerland Number Analyzed 4 participants 3 participants 9 participants 4 participants 11 participants 12 participants 43 participants
4 3 9 4 11 12 43
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of BAL101553
Hide Description First 28-day treatment cycle dose limiting toxicities (DLT) graded according to CTCAE in the MTD-determining population in Phase 1 based on the number of participants with adverse effects as measure of tolerability at various dose levels
Time Frame 28 day cycle
Hide Outcome Measure Data
Hide Analysis Population Description

MTD-determining population in Phase 1: All patients who meet the following minimum criteria during the first 28-day treatment cycle (Cycle 1)

  • received at least one partial or complete dose of BAL101553 and has experienced a DLT;
  • received all three doses of BAL101553 without experiencing a DLT (including the ability to initiate treatment Cycle 2), have been observed for ≥ 28 days following the first dose, and have been evaluated for safety.
Arm/Group Title MTD-determining Population in Phase 1
Hide Arm/Group Description:
All patients meeting the criteria of the MTD-determining population in Phase 1 during the first 28-day treatment cycle with intravenous BAL101553 at doses of 30, 45, 70 and 90 mg/m²
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: mg/m²
70
2.Secondary Outcome
Title Safety and Tolerability of BAL101553 Treatment Based on Number of Patients With Related Treatment-emergent Adverse Events (TEAEs) in the Phase 1 and Phase 2a Safety Population at Various Dose Levels and Indication
Hide Description TEAEs are defined as all events occurring after BAL101553 treatment begins, up to 28 days after last study drug administration according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time Frame TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who receive at least one full or partial dose of BAL101553 and had at least one post-baseline safety assessment is included in the safety analysis population.
Arm/Group Title Phase 1 - 30 mg/m² Cohort Phase 1 - 45 mg/m² Cohort Phase 1 - 70 mg/m² Cohort Phase 1 - 90 mg/m² Cohort Phase 2a - Ovarian Cancer Cohort Phase 2a - Recurrent Glioblastoma Cohort
Hide Arm/Group Description:
BAL101553 30 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 30 mg/m².
BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².
BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².
BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².

BAL101553 at 70 mg/m² (MTD)

BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle

BAL101553 at 70 mg/m² (MTD)

BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
Overall Number of Participants Analyzed 4 3 9 4 11 12
Measure Type: Count of Participants
Unit of Measure: Participants
Patients with ≥1 related AE
2
  50.0%
2
  66.7%
8
  88.9%
3
  75.0%
9
  81.8%
4
  33.3%
Patients with CTCAE Grade 3/4 or severe related AE
0
   0.0%
0
   0.0%
2
  22.2%
2
  50.0%
3
  27.3%
1
   8.3%
Patients with ≥1 related serious AE
0
   0.0%
0
   0.0%
2
  22.2%
1
  25.0%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title AUC of BAL101553 and BAL27862
Hide Description

Pharmacokinetic parameter "Area under the plasma concentration versus time curve" AUC0-last (of BAL101553 and BAL27862 has been assessed after a 48-hour IV infusion.

Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862).
Time Frame 0 to 168 hours post-dose at Day 1 of Cycle 1 and Cycle 2 in each cohort in Phase 1, 28-day cycles
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set includes all patients who received at least one partial or complete dose of study drug and had at least one post-baseline PK assessment.
Arm/Group Title 30 mg/m² Cycle 1 Day 1 30 mg/m² Cycle 2 Day 1 45 mg/m² Cycle 1 Day 1 45 mg/m² Cycle 2 Day 1 70 mg/m² Cycle 1 Day 1 70 mg/m² Cycle 2 Day 1 90 mg/m² Cycle 1 Day 1 90 mg/m² Cycle 2 Day 1
Hide Arm/Group Description:
BAL101553 30 mg/m² Cohort Cycle 1 Day 1
BAL101553 30 mg/m² Cohort Cycle 2 Day 1
BAL101553 45 mg/m² Cohort Cycle 1 Day 1
BAL101553 45 mg/m² Cohort Cycle 2 Day 1
BAL101553 70 mg/m² Cohort Cycle 1 Day 1
BAL101553 70 mg/m² Cohort Cycle 2 Day 1
BAL101553 90 mg/m² Cohort Cycle 1 Day 1
BAL101553 90 mg/m² Cohort Cycle 2 Day 1
Overall Number of Participants Analyzed 4 3 3 2 9 6 4 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*ng/mL
BAL101553
1430
(43.9%)
1310
(47.6%)
2260
(43.9%)
1890
(13.3%)
3560
(45.9%)
3550
(43.1%)
4810
(74.0%)
4150
(67.5%)
BAL27862
1730
(37.8%)
2250
(58.2%)
3440
(45.1%)
3920
(57.7%)
7720
(44.6%)
6640
(49.3%)
10400
(37.2%)
10700
(39.3%)
4.Secondary Outcome
Title Cmax of BAL101553 and BAL27862
Hide Description

Pharmacokinetic parameter "Peak Plasma Concentration" Cmax of BAL101553 and BAL27862.

Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862).
Time Frame Pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 52, 54, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 1 and pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 2.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set includes all patients who received at least one partial or complete dose of study drug and had at least one post-baseline PK assessment.
Arm/Group Title 30 mg/m² Cycle 1 Day 1 30 mg/m² Cycle 2 Day 1 45 mg/m² Cycle 1 Day 1 45 mg/m² Cycle 2 Day 1 70 mg/m² Cycle 1 Day 1 70 mg/m² Cycle 2 Day 1 90 mg/m² Cycle 1 Day 1 90 mg/m² Cycle 2 Day 1
Hide Arm/Group Description:
BAL101553 30 mg/m² Cohort Cycle 1 Day 1
BAL101553 30 mg/m² Cohort Cycle 2 Day 1
BAL101553 45 mg/m² Cohort Cycle 1 Day 1
BAL101553 45 mg/m² Cohort Cycle 2 Day 1
BAL101553 70 mg/m² Cohort Cycle 1 Day 1
BAL101553 70 mg/m² Cohort Cycle 2 Day 1
BAL101553 90 mg/m² Cohort Cycle 1 Day 1
BAL101553 90 mg/m² Cohort Cycle 2 Day 1
Overall Number of Participants Analyzed 4 3 3 2 9 6 4 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
BAL101553
43.0
(22.9%)
44.2
(15.8%)
69.3
(19.3%)
60.9
(4.3%)
119
(34.5%)
111
(34.9%)
174
(63.6%)
198
(76.8%)
BAL27862
45.7
(30.2%)
52.7
(45.8%)
76.8
(18.6%)
76.2
(43.1%)
144
(25.7%)
120
(41.2%)
223
(44.7%)
199
(40.4%)
5.Secondary Outcome
Title Tmax of BAL101553 and BAL27862
Hide Description Pharmacokinetic parameter "Time to Peak Plasma Concentration" Tmax of BAL101553 and BAL27862
Time Frame Pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 52, 54, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 1 and pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 2.
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set includes all patients who received at least one partial or complete dose of study drug and had at least one post-baseline PK assessment.
Arm/Group Title 30 mg/m² Cycle 1 Day 1 30 mg/m² Cycle 2 Day 1 45 mg/m² Cycle 1 Day 1 45 mg/m² Cycle 2 Day 1 70 mg/m² Cycle 1 Day 1 70 mg/m² Cycle 2 Day 1 90 mg/m² Cycle 1 Day 1 90 mg/m² Cycle 2 Day 1
Hide Arm/Group Description:
BAL101553 30 mg/m² Cohort Cycle 1 Day 1
BAL101553 30 mg/m² Cohort Cycle 2 Day 1
BAL101553 45 mg/m² Cohort Cycle 1 Day 1
BAL101553 45 mg/m² Cohort Cycle 2 Day 1
BAL101553 70 mg/m² Cohort Cycle 1 Day 1
BAL101553 70 mg/m² Cohort Cycle 2 Day 1
BAL101553 90 mg/m² Cohort Cycle 1 Day 1
BAL101553 90 mg/m² Cohort Cycle 2 Day 1
Overall Number of Participants Analyzed 4 3 3 2 9 6 4 3
Median (Full Range)
Unit of Measure: hours
BAL101553
39.0
(24.0 to 48.0)
30.0
(24.0 to 48.0)
29.0
(4.03 to 30.0)
27.1
(24.2 to 30.0)
4.00
(1.00 to 24.1)
1.56
(1.00 to 4.05)
2.53
(1.03 to 46.5)
1.17
(1.00 to 3.95)
BAL27862
48.0
(30.1 to 48.0)
48.0
(24.0 to 52.9)
48.0
(29.0 to 48.1)
47.5
(47.2 to 47.9)
47.6
(29.1 to 52.1)
46.6
(7.5 to 54.7)
46.2
(23.8 to 47.5)
47.4
(46.7 to 47.4)
6.Secondary Outcome
Title Bioavailability of Daily Oral BAL101553 Measured by BAL27862 in Phase 1
Hide Description Ratio of AUCs of avanbulin after oral and IV administration (relative bioavailability) of BAL101553 (lisavanbulin) which is the prodrug of avanbulin (BAL27862)
Time Frame Relative oral bioavailability, calculated as dose-normalized AUC0-τ following oral administration on Cycle 2 Day 21 divided by dose normalized AUC0-∞ following IV administration on Cycle 1 Day 1 for each cohort.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with both Cycle 1 Day 1 AUC0-∞ and Cycle 2 Day 1 AUC0-τ evaluations
Arm/Group Title 30 mg/m² 45 mg/m² 70 mg/m² 90 mg/m²
Hide Arm/Group Description:
Patients with both Cycle 1 Day 1 AUC0-∞ and Cycle 2 Day 1 AUC0-τ evaluations
Patients with both Cycle 1 Day 1 AUC0-∞ and Cycle 2 Day 1 AUC0-τ evaluations
Patients with both Cycle 1 Day 1 AUC0-∞ and Cycle 2 Day 1 AUC0-τ evaluations
Patients with both Cycle 1 Day 1 AUC0-∞ and Cycle 2 Day 1 AUC0-τ evaluations
Overall Number of Participants Analyzed 1 1 3 1
Mean (Standard Deviation)
Unit of Measure: Ratio
1.11  (0) 1.32  (0) 0.796  (18.9) 0.893  (0)
7.Secondary Outcome
Title Anti-tumor Activity of BAL101553 by Best Response Rate Per RECIST / RANO Criteria
Hide Description

The objective response rate (ORR) was calculated using the efficacy evaluable populations (EEPs in Phase 2a) and the full analysis population (FAP in Phase 1 and Phase 2a) based on RECIST v1.1 guidelines (defines criteria for the radiological assessment in tumor response) for patients with solid tumors (excluding GBM (glioblastoma)) and RANO criteria (assessment Incorporating MRI and clinical factors) for patients with GBM.

ORR = Rate of complete and partial responses
Time Frame 28 day cycles
Hide Outcome Measure Data
Hide Analysis Population Description

FAP:

Patients who receive at least one partial or complete dose of BAL101553.

EEP:

Patients with progressive disease who completed at least Cycle 1 dosing and at least one on-study tumor assessment (clinical or radiological by RECIST v1.1 or RANO criteria) Patients with stable disease, partial or complete response, based on a radiological assessment by RECIST v1.1 or RANO criteria at the end of Cycle 2, with at least 4 doses of study drug in the first two cycles.
Arm/Group Title Phase 1- in the FAP Phase 2a - Patients With Ovarian Cancer in the FAP Phase 2a - Patients With Ovarian Cancer in the EEP Phase 2a - Patients With Recurrent Glioblastoma in the FAP Phase 2a - Patients With Recurrent Glioblastoma in the EEP
Hide Arm/Group Description:

All dose cohorts (30 mg/m², 45 mg/m², 70 mg/m² and 90 mg/m²) of BAL101553 in patients with advanced solid tumors

BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle; oral capsule daily for one week during Cycle 2

BAL101553 at 70 mg/m² (MTD)

BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle

BAL101553 at 70 mg/m² (MTD)

BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle

BAL101553 at 70 mg/m² (MTD)

BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle

BAL101553 at 70 mg/m² (MTD)

BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
Overall Number of Participants Analyzed 20 11 8 12 8
Measure Type: Count of Participants
Unit of Measure: Participants
Complete response
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Partial response
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
1
  12.5%
Stable disease
3
  15.0%
4
  36.4%
3
  37.5%
2
  16.7%
1
  12.5%
Progressive disease
15
  75.0%
7
  63.6%
5
  62.5%
9
  75.0%
6
  75.0%
Missing
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame First dose of study drug through 28 days after the administration of the last dose
Adverse Event Reporting Description TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
 
Arm/Group Title Phase 1 - 30 mg/m² Cohort Phase 1 - 45 mg/m² Cohort Phase 1 - 70 mg/m² Cohort Phase 1 - 90 mg/m² Cohort Phase 2a - Ovarian Cancer Cohort Phase 2a - Recurrent Glioblastoma Cohort
Hide Arm/Group Description BAL101553 30 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 30 mg/m². BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m². BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m². BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m². BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
All-Cause Mortality
Phase 1 - 30 mg/m² Cohort Phase 1 - 45 mg/m² Cohort Phase 1 - 70 mg/m² Cohort Phase 1 - 90 mg/m² Cohort Phase 2a - Ovarian Cancer Cohort Phase 2a - Recurrent Glioblastoma Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/3 (0.00%)      3/9 (33.33%)      0/4 (0.00%)      3/11 (27.27%)      2/12 (16.67%)    
Hide Serious Adverse Events
Phase 1 - 30 mg/m² Cohort Phase 1 - 45 mg/m² Cohort Phase 1 - 70 mg/m² Cohort Phase 1 - 90 mg/m² Cohort Phase 2a - Ovarian Cancer Cohort Phase 2a - Recurrent Glioblastoma Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      1/3 (33.33%)      7/9 (77.78%)      1/4 (25.00%)      4/11 (36.36%)      5/12 (41.67%)    
Gastrointestinal disorders             
Abdominal pain † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Anal haemorrhage † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Ascites † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Nausea † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Vomiting † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
General disorders             
Asthenia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
General physical health deterioration † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Pyrexia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  1 0/11 (0.00%)  0 0/12 (0.00%)  0
Infections and infestations             
Device related infection † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Pneumonia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Injury, poisoning and procedural complications             
Fall † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 2/12 (16.67%)  2
Femoral neck fracture † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Metastases to peritoneum † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Neoplasm progression † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Nervous system disorders             
Brain oedema † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Nervous system disorder † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Neuropathy peripheral † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Partial seizures † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Seizure † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Somnolence † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Product Issues             
Thrombosis in device † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  3
Surgical and medical procedures             
Bladder neoplasm surgery † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Vascular disorders             
Haematoma † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Hypotension † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Vena cava thrombosis † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
1
Term from vocabulary, MedDRA 19.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase 1 - 30 mg/m² Cohort Phase 1 - 45 mg/m² Cohort Phase 1 - 70 mg/m² Cohort Phase 1 - 90 mg/m² Cohort Phase 2a - Ovarian Cancer Cohort Phase 2a - Recurrent Glioblastoma Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      3/3 (100.00%)      9/9 (100.00%)      4/4 (100.00%)      11/11 (100.00%)      11/12 (91.67%)    
Blood and lymphatic system disorders             
Anaemia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 3/11 (27.27%)  4 1/12 (8.33%)  1
Lymph node pain † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Cardiac disorders             
Palpitations † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Tachycardia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Ear and labyrinth disorders             
Ear pain † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Eye disorders             
Dry eye † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Vision blurred † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 1/12 (8.33%)  1
Gastrointestinal disorders             
Abdominal distension † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Abdominal pain † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 4/9 (44.44%)  4 2/4 (50.00%)  4 6/11 (54.55%)  9 0/12 (0.00%)  0
Abdominal pain upper † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 2/9 (22.22%)  2 0/4 (0.00%)  0 2/11 (18.18%)  4 1/12 (8.33%)  1
Anal haemorrhage † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Anal incontinence † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Ascites † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 2/9 (22.22%)  2 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Constipation † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 4/9 (44.44%)  5 2/4 (50.00%)  2 6/11 (54.55%)  7 2/12 (16.67%)  2
Diarrhoea † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 2/9 (22.22%)  3 1/4 (25.00%)  1 3/11 (27.27%)  6 0/12 (0.00%)  0
Dry mouth † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Dysphagia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Flatulence † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Gastrooesophageal reflux disease † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Haemorrhoidal haemorrhage † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 1/12 (8.33%)  1
Ileus † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Nausea † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 2/9 (22.22%)  2 2/4 (50.00%)  2 1/11 (9.09%)  4 4/12 (33.33%)  4
Proctalgia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 2/11 (18.18%)  2 0/12 (0.00%)  0
Proctitis † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Stomatitis † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Subileus † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Vomiting † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 2/9 (22.22%)  4 1/4 (25.00%)  1 2/11 (18.18%)  2 1/12 (8.33%)  1
General disorders             
Chest discomfort † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Chest pain † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Device related thrombosis † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Fatigue † 1  1/4 (25.00%)  1 2/3 (66.67%)  2 8/9 (88.89%)  9 3/4 (75.00%)  5 6/11 (54.55%)  14 4/12 (33.33%)  4
Gait disturbance † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 1/12 (8.33%)  1
General physical health deterioration † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Influenza like illness † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Localised oedema † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Non-cardiac chest pain † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Oedema peripheral † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 1/9 (11.11%)  1 0/4 (0.00%)  0 2/11 (18.18%)  2 1/12 (8.33%)  1
Pain † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  2 1/11 (9.09%)  2 0/12 (0.00%)  0
Pyrexia † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 1/9 (11.11%)  1 1/4 (25.00%)  3 1/11 (9.09%)  1 1/12 (8.33%)  1
Infections and infestations             
Cystitis † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  2 0/11 (0.00%)  0 1/12 (8.33%)  1
Lip infection † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Localised infection † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Nasopharyngitis † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Oral herpes † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  1 0/11 (0.00%)  0 1/12 (8.33%)  2
Pneumonia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Rhinitis † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Skin infection † 1  0/4 (0.00%)  0 1/3 (33.33%)  2 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Urinary tract infection † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 1/12 (8.33%)  1
Injury, poisoning and procedural complications             
Fall † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 1/12 (8.33%)  1
Vascular access complication † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Wound † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Investigations             
Alanine aminotransferase increased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Aspartate aminotransferase increased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Blood creatine phosphokinase increased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Blood creatinine increased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 2/9 (22.22%)  2 1/4 (25.00%)  1 1/11 (9.09%)  1 1/12 (8.33%)  1
Blood lactate dehydrogenase increased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Creatinine renal clearance decreased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Lymphocyte count decreased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  3
Neutrophil count decreased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  1 0/11 (0.00%)  0 0/12 (0.00%)  0
Platelet count decreased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  1 0/11 (0.00%)  0 1/12 (8.33%)  1
Troponin T increased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 2/12 (16.67%)  2
Weight decreased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 2/9 (22.22%)  2 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Weight increased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
White blood cell count decreased † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  1 0/11 (0.00%)  0 0/12 (0.00%)  0
Metabolism and nutrition disorders             
Decreased appetite † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 4/9 (44.44%)  7 3/4 (75.00%)  3 6/11 (54.55%)  6 1/12 (8.33%)  1
Dehydration † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 1/4 (25.00%)  1 1/11 (9.09%)  1 0/12 (0.00%)  0
Hyperglycaemia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  2
Hyperkalaemia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Hyperuricaemia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Hypoglycaemia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  2 0/12 (0.00%)  0
Hypokalaemia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 2/4 (50.00%)  4 3/11 (27.27%)  4 1/12 (8.33%)  1
Hyponatraemia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 2/9 (22.22%)  2 1/4 (25.00%)  1 1/11 (9.09%)  1 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 1/12 (8.33%)  1
Back pain † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  2 0/4 (0.00%)  0 4/11 (36.36%)  5 0/12 (0.00%)  0
Bone pain † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  1 0/11 (0.00%)  0 0/12 (0.00%)  0
Muscle spasms † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 3/11 (27.27%)  3 2/12 (16.67%)  3
Muscle tightness † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Muscular weakness † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 2/12 (16.67%)  4
Musculoskeletal pain † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 1/11 (9.09%)  1 1/12 (8.33%)  1
Myalgia † 1  1/4 (25.00%)  1 1/3 (33.33%)  1 0/9 (0.00%)  0 1/4 (25.00%)  1 0/11 (0.00%)  0 0/12 (0.00%)  0
Pain in extremity † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  2 0/4 (0.00%)  0 2/11 (18.18%)  2 0/12 (0.00%)  0
Nervous system disorders             
Amnesia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Aphasia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Ataxia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  1 0/11 (0.00%)  0 0/12 (0.00%)  0
Autonomic nervous system imbalance † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Balance disorder † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Brain oedema † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Cognitive disorder † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Disturbance in attention † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Dizziness † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 1/11 (9.09%)  1 1/12 (8.33%)  1
Dysaesthesia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Dysarthria † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  1 0/11 (0.00%)  0 1/12 (8.33%)  1
Dysgeusia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Headache † 1  0/4 (0.00%)  0 1/3 (33.33%)  2 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 3/12 (25.00%)  5
Hemianaesthesia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Hemianopia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Hemiplegia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Memory impairment † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 1/12 (8.33%)  1
Monoparesis † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Neuralgia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Neurologic neglect syndrome † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Paraesthesia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 3/11 (27.27%)  5 2/12 (16.67%)  2
Peripheral sensory neuropathy † 1  1/4 (25.00%)  1 1/3 (33.33%)  1 1/9 (11.11%)  1 0/4 (0.00%)  0 1/11 (9.09%)  7 0/12 (0.00%)  0
Presyncope † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Seizure † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Somnolence † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Psychiatric disorders             
Agitation † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Confusional state † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 1/11 (9.09%)  2 1/12 (8.33%)  1
Depression † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 1/12 (8.33%)  1
Disorientation † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Hallucination † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 2/4 (50.00%)  2 1/11 (9.09%)  1 1/12 (8.33%)  1
Insomnia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 2/4 (50.00%)  3 4/11 (36.36%)  7 0/12 (0.00%)  0
Mental disorder † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Restlessness † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  3 0/11 (0.00%)  0 0/12 (0.00%)  0
Renal and urinary disorders             
Haematuria † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Urinary incontinence † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Urinary retention † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Reproductive system and breast disorders             
Breast pain † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 2/9 (22.22%)  2 1/4 (25.00%)  1 1/11 (9.09%)  1 0/12 (0.00%)  0
Dyspnoea † 1  1/4 (25.00%)  1 0/3 (0.00%)  0 3/9 (33.33%)  4 0/4 (0.00%)  0 4/11 (36.36%)  4 1/12 (8.33%)  1
Epistaxis † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  1 0/11 (0.00%)  0 0/12 (0.00%)  0
Hiccups † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Hypoxia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Pulmonary embolism † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders             
Alopecia † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  1 0/11 (0.00%)  0 1/12 (8.33%)  1
Dry skin † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Eczema † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Hyperhidrosis † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Pruritus † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Rash † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  1 0/11 (0.00%)  0 0/12 (0.00%)  0
Vascular disorders             
Embolism † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Haematoma † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 2/12 (16.67%)  2
Hot flush † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/4 (0.00%)  0 0/11 (0.00%)  0 0/12 (0.00%)  0
Hypertension † 1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/9 (0.00%)  0 0/4 (0.00%)  0 3/11 (27.27%)  6 0/12 (0.00%)  0
Hypotension † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  1 0/11 (0.00%)  0 0/12 (0.00%)  0
Peripheral coldness † 1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
1
Term from vocabulary, MedDRA 19.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Kaindl, MD, Global Medical Director, Oncology
Organization: Basilea Pharmaceutica International Ltd.
Phone: +41615671505
EMail: Thomas.Kaindl@basilea.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Basilea Pharmaceutica
ClinicalTrials.gov Identifier: NCT02895360    
Other Study ID Numbers: CDI-CS-003
First Submitted: September 5, 2016
First Posted: September 9, 2016
Results First Submitted: August 5, 2021
Results First Posted: October 11, 2021
Last Update Posted: December 1, 2022