Trial Outcomes & Findings for Plerixafor and Clofarabine in Frontline Treatment of Elderly Patients With Acute Myelogenous Leukemia (AML) (NCT NCT01160354)

Last Updated: 2019-08-28

Results Overview

Dose limiting toxicity (DLT) consists of participants who developed DLT during maximum tolerated dose (MTD) estimation period where DLTs observed during dose escalation were used to develop MTD. The MTD is the highest dose level in which \<2 participants of 6 develop first cycle. DLT. Toxicity graded according to the NCI Common Toxicity Criteria Version 3.0. The timeframe to assess dose-limiting toxicities (DLT's) will be the first cycle of treatment, i.e. the first 4 weeks on study. The Plerixafor dose to be used in Phase II of the protocol is the highest dose at which no more than 1 of 6 patients experience a DLT in the Phase I part of the protocol or a lower dose selected at the end of dose escalation.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

22 participants

Primary outcome timeframe

First cycle of treatment, i.e. first 4 weeks on study

Results posted on

2019-08-28

Participant Flow

Recruitment Period: August 05, 2010 to May 13, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.

Study was closed early due to slow accrual and did not continue to complete second part (Phase 2). Last cohort of Maximum Tolerated Dose (MTD) level 400 mgc/kg included two participant registrations for study continuation that did not occur.

Participant milestones

Participant milestones
Measure	Plerixafor 240 mcg/kg + Clofarabine Plerixafor 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before hour intravenous (IV) administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).	Plerixafor 320 mcg/kg + Clofarabine Plerixafor 320 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).	Plerixafor 400 mcg/kg + Clofarabine Plerixafor 400 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
Overall Study STARTED	3	4	15
Overall Study COMPLETED	3	3	14
Overall Study NOT COMPLETED	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Plerixafor 240 mcg/kg + Clofarabine Plerixafor 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before hour intravenous (IV) administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).	Plerixafor 320 mcg/kg + Clofarabine Plerixafor 320 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).	Plerixafor 400 mcg/kg + Clofarabine Plerixafor 400 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
Overall Study Death	0	1	1

Baseline Characteristics

Plerixafor and Clofarabine in Frontline Treatment of Elderly Patients With Acute Myelogenous Leukemia (AML)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Plerixafor 240 mcg/kg + Clofarabine n=3 Participants Plerixafor 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).	Plerixafor 320 mcg/kg + Clofarabine n=4 Participants Plerixafor 320 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).	Plerixafor 400 mcg/kg + Clofarabine n=15 Participants Plerixafor 400 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).	Total n=22 Participants Total of all reporting groups
Age, Continuous	69 years n=5 Participants	69 years n=7 Participants	72 years n=5 Participants	71 years n=4 Participants
Age, Customized Range of Years · 60-69	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants
Age, Customized Range of Years · 70-79	1 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants	13 Participants n=4 Participants
Age, Customized Range of Years · 80+	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants	13 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	15 participants n=5 Participants	22 participants n=4 Participants

PRIMARY outcome

Timeframe: First cycle of treatment, i.e. first 4 weeks on study

Population: Intent to treat population included all registered participants.

Outcome measures

Outcome measures
Measure	Plerixafor 240 mcg/kg + Clofarabine n=3 Participants Plerixafor 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).	Plerixafor 320 mcg/kg + Clofarabine n=4 Participants Plerixafor 320 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).	Plerixafor 400 mcg/kg + Clofarabine n=15 Participants Plerixafor 400 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
Number of Participants in Phase I With First Cycle Dose Limiting Toxicities (DLT) Observed	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Assessments following 3 cycles (at 12 weeks) up to 5 cycles (20 weeks)

Population: Two participants were not evaluable due to unrelated early death.

Response defined as Complete remission (CR): Disappearance all clinical +/or radiologic evidence disease. Neutrophil count \>/=1.0x10\^9/L \& platelet count \>/=100x10\^9/L, \& normal bone marrow differential (\</= 5% blasts). Complete Remission without Platelet Recovery (CRp): Peripheral blood \& bone marrow results as for CR, but with platelet counts of \<100x10\^9/L. Partial Remission (PR): Blood count recovery as for CR, but both decrease in marrow blasts \>50% \& not more than 6 to 25% abnormal cells in the marrow.

Outcome measures

Outcome measures
Measure	Plerixafor 240 mcg/kg + Clofarabine n=3 Participants Plerixafor 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).	Plerixafor 320 mcg/kg + Clofarabine n=3 Participants Plerixafor 320 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).	Plerixafor 400 mcg/kg + Clofarabine n=14 Participants Plerixafor 400 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
Participants' Response During First Part of Study CR	2 Participants	1 Participants	5 Participants
Participants' Response During First Part of Study CRp	0 Participants	0 Participants	3 Participants
Participants' Response During First Part of Study PR	0 Participants	0 Participants	1 Participants
Participants' Response During First Part of Study Marrow CR	0 Participants	0 Participants	2 Participants
Participants' Response During First Part of Study No Response, Resistant	1 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Continuously monitored, assessments at 12 weeks

Population: Study halted early without continuing to second part (Phase II). This outcome measure is to analyze the overall response during the Phase II portion of this study. The study was halted early and did not enroll any patients in the phase II portion. Therefore, there are Zero patients to analyze and no data to report.

Overall response (OR) = Complete Remission (CR) + Partial Remission (PR) where response defined: Complete remission (CR): Disappearance all clinical +/or radiologic evidence disease. Neutrophil count \>/=1.0x109/L \& platelet count \>/=100x10\^9/L, \& normal bone marrow differential (\</= 5% blasts). Complete Remission without Platelet Recovery (CRp): Peripheral blood \& bone marrow results as for CR, but with platelet counts of \<100x10\^9/L. Partial Remission (PR): Blood count recovery as for CR, but both decrease in marrow blasts \>50% \& not more than 6 to 25% abnormal cells in the marrow. Treatment Failure: For purposes of efficacy analysis of remission, less than a CR, CRi, or PR categorized as Treatment Failure.

Outcome measures

Outcome data not reported

Adverse Events

Plerixafor 240 mcg/kg + Clofarabine

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Plerixafor 320 mcg/kg + Clofarabine

Serious events: 4 serious events

Other events: 4 other events

Deaths: 1 deaths

Plerixafor 400 mcg/kg + Clofarabine

Serious events: 15 serious events

Other events: 15 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Jan Burger, Associate Professor, Leukemia

The University of Texas (UT) MD Anderson Cancer Center

Phone: 7137927734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Plerixafor 240 mcg/kg + Clofarabine n=3 participants at risk Plerixafor 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).	Plerixafor 320 mcg/kg + Clofarabine n=4 participants at risk Plerixafor 320 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).	Plerixafor 400 mcg/kg + Clofarabine n=15 participants at risk Plerixafor 400 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	25.0% 1/4 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/15 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Cardiac disorders Angina	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Cardiac disorders Atrial Fibrilation	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Psychiatric disorders Confusion	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	25.0% 1/4 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/15 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Investigations Elevated alanine aminotransferase (ALT	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Investigations Elevated Renal Function (creatinine)	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Renal and urinary disorders Elevated renal function	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
General disorders Fever	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Infections and infestations Fungal Pneumonia	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Skin and subcutaneous tissue disorders Hand-foot skin reaction	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Infections and infestations Infection	33.3% 1/3 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	25.0% 1/4 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/15 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Blood and lymphatic system disorders Infection Blood	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	13.3% 2/15 • Number of events 2 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Musculoskeletal and connective tissue disorders Muscle weakness	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	25.0% 1/4 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/15 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Gastrointestinal disorders Nausea/Vomiting	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Blood and lymphatic system disorders Neutropenic fever	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	50.0% 2/4 • Number of events 2 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	40.0% 6/15 • Number of events 11 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Infections and infestations Oral Herpes Simplex Virus	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
General disorders Pain	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	13.3% 2/15 • Number of events 2 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Blood and lymphatic system disorders Prolonged Thrombocytopenia	33.3% 1/3 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/15 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Renal and urinary disorders Renal Failure	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Nervous system disorders Syncope	33.3% 1/3 • Number of events 2 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/15 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Infections and infestations Upper Respiratory Infection	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Infections and infestations Urinary Tract Infection	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	50.0% 2/4 • Number of events 2 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/15 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).

Measure	Plerixafor 240 mcg/kg + Clofarabine n=3 participants at risk Plerixafor 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).	Plerixafor 320 mcg/kg + Clofarabine n=4 participants at risk Plerixafor 320 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).	Plerixafor 400 mcg/kg + Clofarabine n=15 participants at risk Plerixafor 400 mcg/kg daily SQ injection on Days 1-5, 4-6 hours before hour IV administration of Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
Skin and subcutaneous tissue disorders Rash	66.7% 2/3 • Number of events 2 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	75.0% 3/4 • Number of events 5 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	33.3% 5/15 • Number of events 6 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Investigations Increased Alanine aminotransferase (ALT)	100.0% 3/3 • Number of events 4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	50.0% 2/4 • Number of events 3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	26.7% 4/15 • Number of events 9 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Investigations Increased Aspartate aminotransferase (AST)	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Investigations Increased bilirubin	33.3% 1/3 • Number of events 2 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	33.3% 5/15 • Number of events 5 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Gastrointestinal disorders Constiptation	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	13.3% 2/15 • Number of events 2 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Investigations Increased creatinine	33.3% 1/3 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
General disorders Death NOS	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	25.0% 1/4 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	25.0% 1/4 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	13.3% 2/15 • Number of events 2 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	25.0% 1/4 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/15 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Psychiatric disorders Insomnia	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Investigations Increased Lipase	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 2 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
General disorders Nausea	66.7% 2/3 • Number of events 3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	50.0% 2/4 • Number of events 2 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	66.7% 10/15 • Number of events 21 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Nervous system disorders Neuropathy - Sensory	33.3% 1/3 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/15 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
General disorders Pain - Other than general	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
General disorders Pain	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	25.0% 1/4 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	40.0% 6/15 • Number of events 11 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Cardiac disorders Palpitations	0.00% 0/3 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 2 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	0.00% 0/4 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).	6.7% 1/15 • Number of events 1 • Adverse event data collected during 28-day cycle, up to 6 cycles (24 weeks).