Trial Outcomes & Findings for Gleevec in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma (NCT NCT00684411)

Last Updated: 2017-01-05

Results Overview

Overall response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on International Workshop Criteria (IWC) \[Cheson, et al. JCO 2007\]. Per the International Working Group response criteria in lymphoma (Cheson 2007) for target lesions assessed by CT: Complete response (CR): nodes that were greater than 15 mm in greatest transverse diameter at baseline shrank to less than 15 mm in greatest transverse diameter and those that were 11-15 mm in greatest transverse diameter but had a short axis diameter greater than 10 mm had a short axis diameter less than 10mm and a transverse diameter that remained less than 15 mm; partial response (PR) was defined as a decrease in the sum of the product of the diameter of target lesions by more than 50% but not fulfilling criteria for CR. Overall response was defined as CR+PR. .

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Disease was evaluated radiologically at baseline, weeks 8, 16, 24 and every 12 weeks thereafter on treatment. Treatment duration was a median of 56 days (range 5-253 days).

Results posted on

2017-01-05

Participant Flow

12 participants were enrolled between August 2008 and December 2011.

Participant milestones

Participant milestones
Measure	Imatinib Mesylate The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
Overall Study STARTED	12
Overall Study Disease Evaluable	11
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Imatinib Mesylate The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
Overall Study New Primary Cancer	1
Overall Study Disease Progression	10
Overall Study Adverse Event	1

Baseline Characteristics

Gleevec in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imatinib Mesylate n=12 Participants The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
Age, Continuous	70.7 years n=5 Participants
Gender Female	6 Participants n=5 Participants
Gender Male	6 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
International Prognostic Index (IPI) Low	3 participants n=5 Participants
International Prognostic Index (IPI) Low-Intermediate	5 participants n=5 Participants
International Prognostic Index (IPI) High-Intermediate	3 participants n=5 Participants
International Prognostic Index (IPI) High	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Disease was evaluated radiologically at baseline, weeks 8, 16, 24 and every 12 weeks thereafter on treatment. Treatment duration was a median of 56 days (range 5-253 days).

Population: The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=11 Participants The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
Overall Response Rate	0.0 proportion of participants Interval 0.0 to 0.238

SECONDARY outcome

Timeframe: Disease was evaluated radiologically at baseline, on treatment at weeks 8, 16, 24 and every 12 weeks thereafter, off treatment for 6 weeks or until death, whichever occurs first. Treatment duration was a median of 56 days (range 5-253 days).

Population: The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.

Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Disease progression was assessed per International Workshop Criteria (IWC) \[Cheson, et al. JCO 2007\]. Per International Working Group response criteria in lymphoma progressive disease (PD) was defined as the appearance of new lesions; the sum of the product of the diameter (SPD) increasing ≥50% from nadir (smallest value seen during trial) in nodal target lesions overall; or, in any single nodal target lesion, a node with a short axis \> 10 mm must increase \> 50% in greatest transverse diameter or a node with short axis \<10mm must increase by at least 50% to at least 15 mm x 15 mm or have a greatest transverse diameter greater than 15 mm.

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=11 Participants The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
Progression-Free Survival	21 days Interval 15.0 to 28.0

SECONDARY outcome

Timeframe: Participants were followed long-term for survival for the earlier of 6 weeks from the end of treatment or death. Maximum follow-up was 288 days in this study cohort.

Population: The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.

Overall survival is defined as the time from study entry to death or date last known alive.

Outcome measures

Outcome measures
Measure	Imatinib Mesylate n=11 Participants The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
Overall Survival	154 days Interval 35.0 to 242.0

Adverse Events

Imatinib Mesylate

Serious events: 5 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Imatinib Mesylate n=12 participants at risk The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
Blood and lymphatic system disorders Hemoglobin	16.7% 2/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Investigations Leukocytes	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Investigations Lymphophenia	33.3% 4/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Investigations Neutrophils	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypophosphatemia	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypokalemia	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Rash/Desquamation	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.

Other adverse events

Other adverse events
Measure	Imatinib Mesylate n=12 participants at risk The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
Blood and lymphatic system disorders Hemoglobin	25.0% 3/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Cardiac disorders Cardiac	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Eye disorders Vision-blurred	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Eye disorders Vision-flashing lights/floaters	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Eye disorders Ocular	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Diarrhea w/o prior colostomy	16.7% 2/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Dyspepsia	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Nausea	33.3% 4/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Vomiting	16.7% 2/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
General disorders Fatigue	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
General disorders Fever w/o neutropenia	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
General disorders Edema head and neck	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
General disorders Edema limb	16.7% 2/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Infections and infestations Infection Gr0-2 neut, urinary tract	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Investigations Leukocytes	16.7% 2/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Investigations Lymphopenia	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Investigations Neutrophils	16.7% 2/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Investigations Platelets	33.3% 4/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Investigations Alkaline phosphatase	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Investigations AST, SGOT	16.7% 2/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Investigations Bilirubin	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypoalbuminemia	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Bicarbonate	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypocalcemia	25.0% 3/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypophosphatemia	25.0% 3/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hyponatremia	16.7% 2/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Musculoskeletal and connective tissue disorders Extremity-limb, pain	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 2/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Alopecia	8.3% 1/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Rash/desquamation	16.7% 2/12 • Toxicity was evaluated on treatment at weeks 1, 2, every 4 weeks from week 4 until week 28 and then every 12 weeks thereafter starting with week 36. 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 per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.

Additional Information

Eric Jacobsen, MD

Dana-Farber Cancer Institute

Phone: 617.632.6633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place