Trial Outcomes & Findings for A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL (NCT NCT02135133)
NCT ID: NCT02135133
Last Updated: 2024-10-16
Results Overview
The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on IWCLL 2008 criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Disease evaluated on Cycle 2 day 22 (Restage end of cycle 2), Cycle 10 day 1 (Final Restage 2 months after end of ofa therapy) and off treatment prior to cycle 10. Treatment duration is median 243 days with range of 9-620 days.
Results posted on
2024-10-16
Participant Flow
Patients screened between 16 June 2014, and 14 March 2016, and 27 patients ultimately received at least 1 dose of study therapy
Participant milestones
| Measure |
Idelalisib & Ofatumumab
Idelalisib will be given orally continuously at 150 mg BID. On day 57, ofatumumab will begin with the 300 mg dose, given after idelalisib is taken. Ofatumumab will then be administered at 1000 mg weekly to complete 8 weeks (days 64, 71, 78, 85, 92, 99, 106) throughout Cycles 3 and 4. This will be followed by monthly ofatumumab on weeks 20, 24, 28, 32 to complete 4 additional cycles (5-8). The overall induction treatment period will then be 8 months, comprised of two months of single agent idelalisib followed by 6 months of ofatumumab with idelalisib. After the completion of the induction treatment, idelalisib will continue indefinitely in arbitrarily defined 28 day cycles in all participants who have not had excessive toxicity and do not have progressive disease.
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|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Idelalisib & Ofatumumab
Idelalisib will be given orally continuously at 150 mg BID. On day 57, ofatumumab will begin with the 300 mg dose, given after idelalisib is taken. Ofatumumab will then be administered at 1000 mg weekly to complete 8 weeks (days 64, 71, 78, 85, 92, 99, 106) throughout Cycles 3 and 4. This will be followed by monthly ofatumumab on weeks 20, 24, 28, 32 to complete 4 additional cycles (5-8). The overall induction treatment period will then be 8 months, comprised of two months of single agent idelalisib followed by 6 months of ofatumumab with idelalisib. After the completion of the induction treatment, idelalisib will continue indefinitely in arbitrarily defined 28 day cycles in all participants who have not had excessive toxicity and do not have progressive disease.
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|---|---|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
regulatory mandate
|
5
|
Baseline Characteristics
A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL
Baseline characteristics by cohort
| Measure |
Idelalisib & Ofatumumab
n=27 Participants
Idelalisib will be given orally continuously at 150 mg BID. On day 57, ofatumumab will begin with the 300 mg dose, given after idelalisib is taken. Ofatumumab will then be administered at 1000 mg weekly to complete 8 weeks (days 64, 71, 78, 85, 92, 99, 106) throughout Cycles 3 and 4. This will be followed by monthly ofatumumab on weeks 20, 24, 28, 32 to complete 4 additional cycles (5-8). The overall induction treatment period will then be 8 months, comprised of two months of single agent idelalisib followed by 6 months of ofatumumab with idelalisib. After the completion of the induction treatment, idelalisib will continue indefinitely in arbitrarily defined 28 day cycles in all participants who have not had excessive toxicity and do not have progressive disease.
|
|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Not of Hispanic Origin
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American, not of Hispanic Origin
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Disease evaluated on Cycle 2 day 22 (Restage end of cycle 2), Cycle 10 day 1 (Final Restage 2 months after end of ofa therapy) and off treatment prior to cycle 10. Treatment duration is median 243 days with range of 9-620 days.The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on IWCLL 2008 criteria.
Outcome measures
| Measure |
Idelalisib & Ofatumumab
n=27 Participants
Idelalisib will be given orally continuously at 150 mg BID. On day 57, ofatumumab will begin with the 300 mg dose, given after idelalisib is taken. Ofatumumab will then be administered at 1000 mg weekly to complete 8 weeks (days 64, 71, 78, 85, 92, 99, 106) throughout Cycles 3 and 4. This will be followed by monthly ofatumumab on weeks 20, 24, 28, 32 to complete 4 additional cycles (5-8). The overall induction treatment period will then be 8 months, comprised of two months of single agent idelalisib followed by 6 months of ofatumumab with idelalisib. After the completion of the induction treatment, idelalisib will continue indefinitely in arbitrarily defined 28 day cycles in all participants who have not had excessive toxicity and do not have progressive disease.
|
|---|---|
|
Overall Response Rate (ORR)
|
0.89 proportion of participants
Interval 0.77 to 1.0
|
SECONDARY outcome
Timeframe: Disease evaluated on Cycle 2 day 22 (Restage end of cycle 2), Cycle 10 day 1 (Final Restage 2 months after end of ofa therapy) and off treatment prior to cycle 10. Treatment duration is median 243 days with range of 9-620 days.The overall response rate (ORR) was defined as the proportion of participants achieving CR based on IWCLL 2008 criteria.
Outcome measures
| Measure |
Idelalisib & Ofatumumab
n=27 Participants
Idelalisib will be given orally continuously at 150 mg BID. On day 57, ofatumumab will begin with the 300 mg dose, given after idelalisib is taken. Ofatumumab will then be administered at 1000 mg weekly to complete 8 weeks (days 64, 71, 78, 85, 92, 99, 106) throughout Cycles 3 and 4. This will be followed by monthly ofatumumab on weeks 20, 24, 28, 32 to complete 4 additional cycles (5-8). The overall induction treatment period will then be 8 months, comprised of two months of single agent idelalisib followed by 6 months of ofatumumab with idelalisib. After the completion of the induction treatment, idelalisib will continue indefinitely in arbitrarily defined 28 day cycles in all participants who have not had excessive toxicity and do not have progressive disease.
|
|---|---|
|
Complete Response Rate (CRR)
|
0.037 proportion of participants
Interval -0.03 to 0.11
|
SECONDARY outcome
Timeframe: Disease evaluated on Cycle 2 day 22, Cycle 10 day 1 and off treatment prior to cycle 10. In long term, survival follow-up yearly. The median follow up time among survivors was 32.2 months (range 13, 35).Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) or death, or is censored at time of last dsease assessment.
Outcome measures
| Measure |
Idelalisib & Ofatumumab
n=27 Participants
Idelalisib will be given orally continuously at 150 mg BID. On day 57, ofatumumab will begin with the 300 mg dose, given after idelalisib is taken. Ofatumumab will then be administered at 1000 mg weekly to complete 8 weeks (days 64, 71, 78, 85, 92, 99, 106) throughout Cycles 3 and 4. This will be followed by monthly ofatumumab on weeks 20, 24, 28, 32 to complete 4 additional cycles (5-8). The overall induction treatment period will then be 8 months, comprised of two months of single agent idelalisib followed by 6 months of ofatumumab with idelalisib. After the completion of the induction treatment, idelalisib will continue indefinitely in arbitrarily defined 28 day cycles in all participants who have not had excessive toxicity and do not have progressive disease.
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|---|---|
|
Median Progression-Free Survival (PFS)
|
NA months
Median and range not statistically reachable by Kaplan-Meier method because no enough events
|
Adverse Events
Idelalisib & Ofatumumab
Serious events: 6 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Idelalisib & Ofatumumab
n=27 participants at risk
Idelalisib will be given orally continuously at 150 mg BID. On day 57, ofatumumab will begin with the 300 mg dose, given after idelalisib is taken. Ofatumumab will then be administered at 1000 mg weekly to complete 8 weeks (days 64, 71, 78, 85, 92, 99, 106) throughout Cycles 3 and 4. This will be followed by monthly ofatumumab on weeks 20, 24, 28, 32 to complete 4 additional cycles (5-8). The overall induction treatment period will then be 8 months, comprised of two months of single agent idelalisib followed by 6 months of ofatumumab with idelalisib. After the completion of the induction treatment, idelalisib will continue indefinitely in arbitrarily defined 28 day cycles in all participants who have not had excessive toxicity and do not have progressive disease.
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|---|---|
|
Investigations
Alanine aminotransferase increased
|
14.8%
4/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Aspartate aminotransferase increased
|
14.8%
4/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Neutrophil count decreased
|
7.4%
2/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
Other adverse events
| Measure |
Idelalisib & Ofatumumab
n=27 participants at risk
Idelalisib will be given orally continuously at 150 mg BID. On day 57, ofatumumab will begin with the 300 mg dose, given after idelalisib is taken. Ofatumumab will then be administered at 1000 mg weekly to complete 8 weeks (days 64, 71, 78, 85, 92, 99, 106) throughout Cycles 3 and 4. This will be followed by monthly ofatumumab on weeks 20, 24, 28, 32 to complete 4 additional cycles (5-8). The overall induction treatment period will then be 8 months, comprised of two months of single agent idelalisib followed by 6 months of ofatumumab with idelalisib. After the completion of the induction treatment, idelalisib will continue indefinitely in arbitrarily defined 28 day cycles in all participants who have not had excessive toxicity and do not have progressive disease.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
48.1%
13/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Aspartate aminotransferase increased
|
48.1%
13/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Neutrophil count decreased
|
40.7%
11/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fever
|
40.7%
11/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Diarrhea
|
37.0%
10/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fatigue
|
29.6%
8/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
29.6%
8/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Nausea
|
25.9%
7/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
22.2%
6/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.5%
5/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.8%
4/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Chills
|
14.8%
4/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
14.8%
4/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
14.8%
4/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
3/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Colitis
|
11.1%
3/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
3/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
3/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Dysgeusia
|
11.1%
3/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Edema limbs
|
11.1%
3/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Infections and infestations - Other, specify
|
11.1%
3/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.1%
3/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
3/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Alkaline phosphatase increased
|
7.4%
2/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.4%
2/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Blood bilirubin increased
|
7.4%
2/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Bronchial infection
|
7.4%
2/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.4%
2/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.4%
2/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.4%
2/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Lung infection
|
7.4%
2/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Malaise
|
7.4%
2/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
7.4%
2/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.4%
2/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Weight loss
|
7.4%
2/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
White blood cell decreased
|
7.4%
2/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Immune system disorders
Allergic reaction
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Dizziness
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Esophageal pain
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Esophagitis
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Flatulence
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Flu like symptoms
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Headache
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypertension
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Lip infection
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Mucositis oral
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Platelet count decreased
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Skin infection
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Stomach pain
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Thromboembolic event
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Upper respiratory infection
|
3.7%
1/27 • AEs were evaluated on treatment cycle 1-8 weekly, restage cycle 4 day 2, cycle 10 day 1, and off treatment prior to cycle 10. AE evaluation period is median 243 days with range of 9-620 days. Same with mortality.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 4 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
Additional Information
Jennifer R. Brown, MD, PhD
Dana-Farber Cancer Institute
Phone: (877) 442-3324
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place