Trial Outcomes & Findings for Brentuximab Vedotin, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma (NCT NCT02227199)

Last Updated: 2025-11-18

Results Overview

Will be defined as the dose at which =\< 1 of 6 patients experience a dose-limiting toxicity. Dose-limiting toxicity will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

45 participants

Primary outcome timeframe

Up to 28 days following the second course of chemotherapy, approximately 70 days

Results posted on

2025-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Phase I: Dose Escalation, Dose Level 1 (brentuximab 1.2mg/kg, ifosfamide, carboplatin, etoposide) Patients receive brentuximab Vedotin 1.2mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies	Phase I: Dose Escalation, Dose Level 1 (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide) Patients receive brentuximab Vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies	Phase 2: Dose Expansion (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide) Patients receive brentuximab Vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies
Overall Study STARTED	3	3	39
Overall Study COMPLETED	3	3	35
Overall Study NOT COMPLETED	0	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I: Dose Escalation, Dose Level 1 (brentuximab 1.2mg/kg, ifosfamide, carboplatin, etoposide) Patients receive brentuximab Vedotin 1.2mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies	Phase I: Dose Escalation, Dose Level 1 (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide) Patients receive brentuximab Vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies	Phase 2: Dose Expansion (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide) Patients receive brentuximab Vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies
Overall Study Physician Decision	0	0	1
Overall Study Adverse Event	0	0	3

Baseline Characteristics

Brentuximab Vedotin, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase II: Dose Expansion (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide) n=39 Participants Patients receive brentuximab vedotin 1.5mg/kgIV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies	Total n=45 Participants Total of all reporting groups	Phase I: Dose Escalation, Dose Level 1 (Brentuximab 1.2mg/kg, Ifosfamide, Carboplatin, Etoposide) n=3 Participants Patients receive brentuximab vedotin 1.2mg/kgIV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies	Phase I: Dose Escalation, Dose Level 2 (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide) n=3 Participants Patients receive brentuximab vedotin 1.5mg/kgIV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies
Race (NIH/OMB) Black or African American	2 Participants n=120 Participants	2 Participants n=122 Participants	0 Participants n=202 Participants	0 Participants n=283 Participants
Age, Categorical <=18 years	0 Participants n=120 Participants	0 Participants n=122 Participants	0 Participants n=202 Participants	0 Participants n=283 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=120 Participants	45 Participants n=122 Participants	3 Participants n=202 Participants	3 Participants n=283 Participants
Age, Categorical >=65 years	0 Participants n=120 Participants	0 Participants n=122 Participants	0 Participants n=202 Participants	0 Participants n=283 Participants
Sex: Female, Male Female	27 Participants n=120 Participants	29 Participants n=122 Participants	2 Participants n=202 Participants	0 Participants n=283 Participants
Sex: Female, Male Male	12 Participants n=120 Participants	16 Participants n=122 Participants	1 Participants n=202 Participants	3 Participants n=283 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=120 Participants	4 Participants n=122 Participants	0 Participants n=202 Participants	0 Participants n=283 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=120 Participants	41 Participants n=122 Participants	3 Participants n=202 Participants	3 Participants n=283 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=120 Participants	0 Participants n=122 Participants	0 Participants n=202 Participants	0 Participants n=283 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=120 Participants	0 Participants n=122 Participants	0 Participants n=202 Participants	0 Participants n=283 Participants
Race (NIH/OMB) Asian	4 Participants n=120 Participants	4 Participants n=122 Participants	0 Participants n=202 Participants	0 Participants n=283 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=120 Participants	0 Participants n=122 Participants	0 Participants n=202 Participants	0 Participants n=283 Participants
Race (NIH/OMB) White	32 Participants n=120 Participants	38 Participants n=122 Participants	3 Participants n=202 Participants	3 Participants n=283 Participants
Race (NIH/OMB) More than one race	0 Participants n=120 Participants	0 Participants n=122 Participants	0 Participants n=202 Participants	0 Participants n=283 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=120 Participants	1 Participants n=122 Participants	0 Participants n=202 Participants	0 Participants n=283 Participants
Region of Enrollment United States	39 participants n=120 Participants	45 participants n=122 Participants	3 participants n=202 Participants	3 participants n=283 Participants

PRIMARY outcome

Timeframe: Up to 28 days following the second course of chemotherapy, approximately 70 days

Outcome measures

Outcome measures
Measure	Treatment (brentuximab, ifosfamide, carboplatin, etoposide) n=6 Participants Patients receive brentuximab vedotin IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies	Phase I: Dose Escalation, Dose Level 2 (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide) Patients receive brentuximab Vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies	Phase II: Dose Expansion (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide) Patients receive brentuximab Vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies
Maximum Tolerated Dose of Brentuximab Vedotin That Can be Combined With Ifosfamide, Carboplatin, and Etoposide Chemotherapy	1.5 mg/kg	—	—

PRIMARY outcome

Timeframe: 3 weeks following the completion of chemotherapy

Outcome measures

Outcome measures
Measure	Treatment (brentuximab, ifosfamide, carboplatin, etoposide) n=3 Participants Patients receive brentuximab vedotin IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies	Phase I: Dose Escalation, Dose Level 2 (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide) n=3 Participants Patients receive brentuximab Vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies	Phase II: Dose Expansion (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide) n=39 Participants Patients receive brentuximab Vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies
Percentage of Patients That Achieve a Complete Remission Following Study Treatment	3 Participants	3 Participants	26 Participants

SECONDARY outcome

Timeframe: Up to 2 years from initiation of study therapy.

Outcome measures

Outcome measures
Measure	Treatment (brentuximab, ifosfamide, carboplatin, etoposide) n=3 Participants Patients receive brentuximab vedotin IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies	Phase I: Dose Escalation, Dose Level 2 (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide) n=3 Participants Patients receive brentuximab Vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies	Phase II: Dose Expansion (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide) n=39 Participants Patients receive brentuximab Vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies
2 Year Overall Survival	3 Participants	3 Participants	37 Participants

SECONDARY outcome

Timeframe: Up to 2 years from initiation of therapy.

Outcome measures

Outcome measures
Measure	Treatment (brentuximab, ifosfamide, carboplatin, etoposide) n=3 Participants Patients receive brentuximab vedotin IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies	Phase I: Dose Escalation, Dose Level 2 (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide) n=3 Participants Patients receive brentuximab Vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies	Phase II: Dose Expansion (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide) n=39 Participants Patients receive brentuximab Vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies
2 Year Progression-free Survival	2 Participants	3 Participants	33 Participants

Adverse Events

Phase 1: Dose Escalation, Dose Level 1 (brentuximab 1.2mg/kg, ifosfamide, carboplatin, etoposide)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1: Dose Escalation, Dose Level 2 (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 2: Dose Expansion, Dose Level 2 (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide)

Serious events: 11 serious events

Other events: 39 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1: Dose Escalation, Dose Level 1 (brentuximab 1.2mg/kg, ifosfamide, carboplatin, etoposide) n=3 participants at risk Patients receive brentuximab vedotin 1.2mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies	Phase 1: Dose Escalation, Dose Level 2 (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide) n=3 participants at risk Patients receive brentuximab vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician. Brentuximab Vedotin: Given IV Carboplatin: Given IV Etoposide: Given IV Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies	Phase 2: Dose Expansion, Dose Level 2 (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide) n=39 participants at risk Patients receive brentuximab vedotin 1.5mg/kg IV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.
Endocrine disorders Diabetic Ketoacidosis	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	5.1% 2/39 • Number of events 2 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.
Investigations Elevated Lactate	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	5.1% 2/39 • Number of events 2 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.
General disorders Fever	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	33.3% 1/3 • Number of events 1 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	7.7% 3/39 • Number of events 3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.
Vascular disorders Hypotension	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	33.3% 1/3 • Number of events 1 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	5.1% 2/39 • Number of events 2 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.
General disorders Neutropenic Fever	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	7.7% 3/39 • Number of events 3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.
Infections and infestations Septic Shock	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	2.6% 1/39 • Number of events 1 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.
Infections and infestations Sepsis	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	33.3% 1/3 • Number of events 1 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	10.3% 4/39 • Number of events 4 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	2.6% 1/39 • Number of events 1 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.
Vascular disorders Pulmonary Embolism	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	2.6% 1/39 • Number of events 1 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.
Skin and subcutaneous tissue disorders Sweet Syndrome	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	2.6% 1/39 • Number of events 1 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.
Skin and subcutaneous tissue disorders Erythematous Rash	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	33.3% 1/3 • Number of events 1 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	2.6% 1/39 • Number of events 1 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.
Cardiac disorders Tachycardia	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	2.6% 1/39 • Number of events 1 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.
Gastrointestinal disorders Gastroenteritis	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	2.6% 1/39 • Number of events 1 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	0.00% 0/3 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.	2.6% 1/39 • Number of events 1 • Adverse events were collected starting after the first dose of study treatment and collected through 30 days after the last dose of study drug, or until the patient receives an alternative anti-cancer therapy, whichever date comes first, approximately 60 days.

Other adverse events

Additional Information

Dr. Ajay Gopal

University of Washington

Phone: 26-606-2037

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place