Trial Outcomes & Findings for Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer (NCT NCT00953576)
NCT ID: NCT00953576
Last Updated: 2018-09-04
Results Overview
The MTD of lapatinib in combination with KHAD is determined by the number of participants who experience a dose limiting toxicity (DLT) at the various dose levels of lapatinib under evaluation. See subsequent primary outcome measure for the DLT definition. The MTD is defined as the lapatinib dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached and the Recommended Phase II Dose (RP2D) will be based on safety and pharmacokinetic results.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
The evaluation for MTD occurred continuously through one cycle of KHLAD treatment (28 days).
Results posted on
2018-09-04
Participant Flow
Participants enrolled from September 2009 until December 2011.
Participant milestones
| Measure |
Phase I Dose Level 1: KHAD+L (250 mg)
For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 250 mg orally 1x day
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
Phase I Dose Level 2: KHAD+L (500 mg)
For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
DLT Evaluable
|
3
|
5
|
|
Overall Study
Treated
|
4
|
5
|
|
Overall Study
Pharmacokinetic (PK) Evaluable
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Phase I Dose Level 1: KHAD+L (250 mg)
For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 250 mg orally 1x day
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
Phase I Dose Level 2: KHAD+L (500 mg)
For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Ineligible after Consent
|
2
|
0
|
Baseline Characteristics
Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer
Baseline characteristics by cohort
| Measure |
Phase I Dose Level 1: KHAD+L (250 mg)
n=6 Participants
For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 250 mg orally 1x day
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
Phase I Dose Level 2: KHAD+L (500 mg)
n=5 Participants
For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
67 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The evaluation for MTD occurred continuously through one cycle of KHLAD treatment (28 days).Population: The analysis dataset is comprised of all DLT evaluable participants.
The MTD of lapatinib in combination with KHAD is determined by the number of participants who experience a dose limiting toxicity (DLT) at the various dose levels of lapatinib under evaluation. See subsequent primary outcome measure for the DLT definition. The MTD is defined as the lapatinib dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached and the Recommended Phase II Dose (RP2D) will be based on safety and pharmacokinetic results.
Outcome measures
| Measure |
All Phase I Participants KHAD+L
n=8 Participants
For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: orally 1x day according to the established dose escalation schedule
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
Phase I Dose Level 2: KHAD+L (500 mg)
For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
|---|---|---|
|
Lapatinib Maximum Tolerated Dose (MTD) [Phase I]
|
NA mg 1x daily
While 2 DLTs occurred at DL2, the MTD was not established as DL1 because based on PK analysis, the observed level of lapatinib was well above therapeutic levels which raised sufficient concern to terminate the study.
|
—
|
PRIMARY outcome
Timeframe: The evaluation for DLT occurred continuously through one cycle of treatment (28 days).Population: The analysis dataset is comprised of all DLT evaluable participants.
A DLT is defined as an adverse event (AE) occurring during the first cycle of KHLAD treatment that are determined to related to the Lapatinib or the combination as follows: 1. Any Grade 3 or greater non-hematological treatment related (possible, probable, or definite attribution) including diarrhea 2. Grade 4 or greater for hematological toxicities, regardless of attribution. 3. Grade 3 skin reactions, pulmonary reactions, regardless of attribution.
Outcome measures
| Measure |
All Phase I Participants KHAD+L
n=3 Participants
For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: orally 1x day according to the established dose escalation schedule
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
Phase I Dose Level 2: KHAD+L (500 mg)
n=5 Participants
For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
|---|---|---|
|
Lapatinib Dose Limiting Toxicity (DLT) [Phase I]
|
0 participants with DLT
|
2 participants with DLT
|
PRIMARY outcome
Timeframe: After first 28 days of KHLAD treatmentPopulation: The analysis dataset is comprised of participants who received KHLAD and had an evaluable plasma sample after the first cycle (day 28).
Plasma lapatinib levels were measured after day 28 of KHLAD treatment. Participants were instructed to fast prior to samples being taken.
Outcome measures
| Measure |
All Phase I Participants KHAD+L
n=4 Participants
For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: orally 1x day according to the established dose escalation schedule
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
Phase I Dose Level 2: KHAD+L (500 mg)
n=3 Participants
For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
|---|---|---|
|
Plasma Lapatinib Levels [Phase I]
|
731 ng/mL
Interval 416.0 to 1424.0
|
1506 ng/mL
Interval 680.0 to 2186.0
|
SECONDARY outcome
Timeframe: Assessed each cycle throughout treatment. Treatment duration in months was a median (range) of 5.4 months (range 1 day-8.3 months). Thus, AEs were evaluated up to 8.3 months.Population: The analysis dataset is comprised of all participants who ever started treatment.
All grade 3-4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted to calculate the proportion of participants experiencing at least one treatment-related grade 3 or 4 AE of any type on treatment.
Outcome measures
| Measure |
All Phase I Participants KHAD+L
n=4 Participants
For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: orally 1x day according to the established dose escalation schedule
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
Phase I Dose Level 2: KHAD+L (500 mg)
n=5 Participants
For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
|---|---|---|
|
Grade 3-4 Treatment-Related Adverse Events Rate
|
0 proportion of participants
Interval 0.0 to 0.451
|
0.40 proportion of participants
Interval 0.076 to 0.811
|
Adverse Events
Phase I Dose Level 1: KHAD+L (250 mg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase I Dose Level 2: KHAD+L (500 mg)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I Dose Level 1: KHAD+L (250 mg)
n=4 participants at risk
For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 250 mg orally 1x day
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
Phase I Dose Level 2: KHAD+L (500 mg)
n=5 participants at risk
For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
|---|---|---|
|
Cardiac disorders
Cardiac-other
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
Other adverse events
| Measure |
Phase I Dose Level 1: KHAD+L (250 mg)
n=4 participants at risk
For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 250 mg orally 1x day
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
Phase I Dose Level 2: KHAD+L (500 mg)
n=5 participants at risk
For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day
Participants are treated until unacceptable toxicity, disease progression or withdrawal.
|
|---|---|---|
|
Investigations
ALT, SGPT
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Amylase
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
AST, SGOT
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
75.0%
3/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Cardiac-other
|
50.0%
2/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Chest wall, pain
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Creatinine
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Edema limb
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Endocrine disorders
Endocrine-other
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fatigue
|
75.0%
3/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
100.0%
5/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fever w/o neutropenia
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
GI-other
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Incontinence, anal
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, urinary tract
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ gr3-4 neut, urinary tract
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ unk ANC ungual (nails)
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
50.0%
2/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Lip, pain
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Lipase
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Lymphatics-other
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reaction
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Neuropathy-motor
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic lower extr muscle weak
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Pain-other
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
QTc interval
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Rectum, hemorrhage
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Renal failure
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Renal/GU-other
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Rigors/chills
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
50.0%
2/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Stoma, GI hemorrhage
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Reproductive system and breast disorders
Testicle, pain
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Urine color
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
40.0%
2/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Weight gain
|
0.00%
0/4 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
20.0%
1/5 • Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months.
The analysis dataset is comprised of all participants who ever started treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place