ME-344 Given in Combination With Hycamtin® in Patients With Solid Tumors

• Sponsor: MEI Pharma, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02100007
• Collaborator: SCRI Development Innovations, LLC (Other)
• Enrollment: 46
• Locations: 10
• Arm: 1
• Duration (Months): 24
• Patients Per Site: 4.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and tolerability of ME-344 when given in combination with Hycamtin® in patients with solid tumors

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors	Drug: ME-344; Drug: Topotecan	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase Ib Open Label Study of the Safety and Tolerability of ME-344 Given in Combination With Topotecan (Hycamtin®) in Patients With Solid Tumors
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: ME-344 ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle

Drug: ME-344; Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle. Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.; Other Names: open label ; Drug: Topotecan; Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.; Other Names: Hycamtin®

Outcome Measures

Primary Outcome Measures

1. Number of Adverse Events [Through study completion- an average of 2 years]

   The AE Profile will be determined by the number of AEs regardless of severity

2. Number of Serious Adverse Events [Through study completion- an average of 2 years]

   The SAE Profile will be determined by the number of SAEs

Secondary Outcome Measures

1. Maximum Plasma Concentration (Cmax) [Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion]

   Peak Plasma Concentration (Cmax) of ME-344 in combination with topotecan

2. Time to Maximum Plasma Concentration for ME-344 (Tmax) [Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion]

   Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.

3. Minimum Plasma Concentration (Cmin) of ME-344 [Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion]

   Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.

4. Mean Terminal Half-life (t 1/2) [Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion]

   Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.

5. Estimate Overall Response Rate for ME-344 Given in Combination With Topotecan [Response was assessed throughout the trial up to 13 months]

   Overall response rate was defined as the total number of patients with Complete Response plus Partial Response. All efficacy assessments were to include a baseline assessment and follow-up assessments at a minimum of every 8 weeks for the first 6 cycles, then every 12 weeks thereafter, while receiving study drug. Tumor response and progression-free survival were assessed using RECIST 1.1 criteria or GCIG criteria for CA-125 levels.

6. Estimate the Overall Survival (OS) [Up to 2 years]

   41 subjects were analysed. Overall survival is defined as the first day of study drug administration to death.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologic or cytologic confirmed locally advanced or metastatic small cell lung cancer, ovarian cancer, or cervical cancer (Part 1); small cell lung cancer and ovarian cancer (Part 2)

• Patients with ovarian and small cell lung cancer must have failed initial therapy

• Patients with carcinoma of the cervix must have advanced disease not amenable to curative surgery and/or radiation therapy

• Patients may not have received more than 4 prior regimens of therapy

• Patients may not previously have received irinotecan, topotecan or other topoisomerase I inhibitor

• ECOG Performance status 0-1 (Appendix B)

• A minimum life expectancy of 12 weeks

• Adequate bone marrow, hepatic and renal function as evidenced by:

• Absolute neutrophil count (ANC) > 1.5 x 109/L

• Platelet count > 100 x 109/L

• Hemoglobin > 9.0 g/dL

• Serum bilirubin < 1.5 x ULN

• AST/ALT (SGOT/SGPT) < 2.5 x ULN for the reference laboratory or < 5 x --ULN in the presence of liver metastases

• Serum creatinine < 1.5 x ULN or creatinine clearance ≥ 60 mL/min as measured by institutional standards

• At least 21 days must have elapsed prior to Day 1 Cycle 1, since any radiotherapy, immunotherapy or following major surgery; any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 since "limited palliative radiotherapy", defined as a course of therapy encompassing <25% total bone marrow volume and not exceeding 30 GY.

Exclusion Criteria:

• Patients with tumor involvement of the Central Nervous System (CNS). SCLC patients with previously treated CNS lesions must have stable CNS disease for at least 4 weeks

• Patients with uncontrolled infection or systemic disease

• Patients with clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease e.g. angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months

• Patients who have toxicity from last prior therapy that has not recovered to at least Grade 1, with the exception of Grade 2 alopecia

• Patients who have had any chemotherapy regimens, biologic, or targeted therapies within the 2 weeks prior to Cycle 1 Day 1

• Patients with any neuropathy > Grade 1

• Patients with known hypersensitivity to any components of ME-344 or topotecan study drug product

• Patients with known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both)

• Patients with a history of solid organ transplantation

• Patients with presence of concurrent or active malignant disease (other than disease under study) within the last 12 months with the exception of adequately treated in-situ carcinomas, basal or squamous cell carcinoma, or non-melanomatous skin cancer.

Patients with any psychiatric disorder or social or geographic situation that would preclude study participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pinnacle Oncology Hematology	Scottsdale	Arizona	United States	85258
2	University of Colorado Cancer Center	Aurora	Colorado	United States	80045
3	Northwestern University	Chicago	Illinois	United States	60611
4	Oncology Hematology Care	Cincinnati	Ohio	United States	45242
5	University of Oklahoma	Oklahoma City	Oklahoma	United States	73104
6	Medical University of South Carolina	Charleston	South Carolina	United States	29425
7	Tennessee Oncology, PLLC	Nashville	Tennessee	United States	37203
8	University of WA Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
9	The Bays St Mary's Hospital	London	England	United Kingdom	W2 1NY
10	Sarah Cannon Research Instititute UK	London	England	United Kingdom	WIG 6AD

Sponsors and Collaborators

• MEI Pharma, Inc.
• SCRI Development Innovations, LLC

Investigators

• Study Director: Richard Ghalie, MD, MEI Pharma, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Sponsor website

Publications

None provided.

• Responsible Party: MEI Pharma, Inc.
• ClinicalTrials.gov Identifier: NCT02100007
• Other Study ID Numbers: ME-344-002
• First Posted: Mar 31, 2014
• Last Update Posted: Oct 2, 2017
• Last Verified: Aug 1, 2015

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by MEI Pharma, Inc.: solid tumors; relapsed; advanced; metastatic; small cell lung cancer; ovarian cancer; refractory
• Additional relevant MeSH terms: Neoplasms; Topotecan

Study Results

Participant Flow

Recruitment Details	This study was open to recruitment from April 30, 2014 through December 7, 2015 at 7 investigational sites in the USA and 2 sites in the United Kingdom. Forty-six patients were enrolled. The study was conducted in two parts. Fourteen (14) patients enrolled in Part 1 and 32 subjects were enrolled in Part 2.
Pre-assignment Detail	Fifty-eight (58) potential participants were screened; 46 subjects passed screening and were enrolled in the study.

Arm/Group Title	ME-344
Arm/Group Description	ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle. Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator. Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.
Period Title: Overall Study
STARTED	46
COMPLETED	46
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	ME-344
Arm/Group Description	ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle. Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator. Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.
Overall Participants	46
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	34 73.9%
>=65 years	12 26.1%
Age (Years) [Median (Full Range) ]
Median (Full Range) [Years]	59.5
Sex: Female, Male (Count of Participants)
Female	40 87%
Male	6 13%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 6.5%
Not Hispanic or Latino	41 89.1%
Unknown or Not Reported	2 4.3%
Race/Ethnicity, Customized (Count of Participants)
White	42 91.3%
Black or African American	1 2.2%
Asian	2 4.3%
Other	1 2.2%
Region of Enrollment (participants) [Number]
United States	38 82.6%
United Kingdom	8 17.4%

Outcome Measures

1. Primary Outcome

Title	Number of Adverse Events
Description	The AE Profile will be determined by the number of AEs regardless of severity
Time Frame	Through study completion- an average of 2 years

Outcome Measure Data

Analysis Population Description

46 subjects received > 2 doses of ME-344 and topotecan and were eligible for DLT analysis.

Arm/Group Title	ME-344
Arm/Group Description	ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle. Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator. Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.
Measure Participants	46
Number [adverse events]	595

2. Primary Outcome

Title	Number of Serious Adverse Events
Description	The SAE Profile will be determined by the number of SAEs
Time Frame	Through study completion- an average of 2 years

Outcome Measure Data

Analysis Population Description

46 subjects received > 2 doses of ME-344 and topotecan and were eligible for DLT analysis.

Arm/Group Title	ME-344
Arm/Group Description	ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle ...
Measure Participants	46
Number [SAEs]	23

3. Secondary Outcome

Title	Maximum Plasma Concentration (Cmax)
Description	Peak Plasma Concentration (Cmax) of ME-344 in combination with topotecan
Time Frame	Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion

Outcome Measure Data

Analysis Population Description

Pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data from 13 patients who received treatment in Part 1 of the study.

Arm/Group Title	ME-344
Arm/Group Description	ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle. Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator. Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.
Measure Participants	12
Mean (Standard Deviation) [ng/mL]	20880 (8201.3)

4. Secondary Outcome

Title	Time to Maximum Plasma Concentration for ME-344 (Tmax)
Description	Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.
Time Frame	Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion

Outcome Measure Data

Analysis Population Description

Samples were collected from patients in Part 1 of the study for measurement of plasma concentration of ME-344. Samples were collected from 13 patients in Part 1

Arm/Group Title	ME-344
Arm/Group Description	ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle. Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator. Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.
Measure Participants	13
Mean (Full Range) [hours]	0.5

5. Secondary Outcome

Title	Minimum Plasma Concentration (Cmin) of ME-344
Description	Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.
Time Frame	Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion

Outcome Measure Data

Analysis Population Description

Samples were collected from patients in Part 1 of the study for measurement of plasma concentration of ME-344. Samples were collected from 13 patients in Part 1.

Arm/Group Title	ME-344
Arm/Group Description	ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle. Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator. Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.
Measure Participants	13
Mean (Standard Deviation) [ng/mL]	25.3 (12.824)

6. Secondary Outcome

Title	Mean Terminal Half-life (t 1/2)
Description	Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.
Time Frame	Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion

Outcome Measure Data

Analysis Population Description

Samples were collected from patients in Part 1 of the study for measurement of plasma concentration of ME-344. Samples were collected from 13 patients in Part 1.

Arm/Group Title	ME-344
Arm/Group Description	ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle. Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator. Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.
Measure Participants	13
Mean (Standard Deviation) [hours]	5.301 (2.0114)

7. Secondary Outcome

Title	Estimate Overall Response Rate for ME-344 Given in Combination With Topotecan
Description	Overall response rate was defined as the total number of patients with Complete Response plus Partial Response. All efficacy assessments were to include a baseline assessment and follow-up assessments at a minimum of every 8 weeks for the first 6 cycles, then every 12 weeks thereafter, while receiving study drug. Tumor response and progression-free survival were assessed using RECIST 1.1 criteria or GCIG criteria for CA-125 levels.
Time Frame	Response was assessed throughout the trial up to 13 months

Outcome Measure Data

Analysis Population Description

Part 1 (N =12), Part 2 (N=29)

Arm/Group Title	ME-344
Arm/Group Description	ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle. Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator. Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.
Measure Participants	41
Number [participants]	1 2.2%

8. Secondary Outcome

Title	Estimate the Overall Survival (OS)
Description	41 subjects were analysed. Overall survival is defined as the first day of study drug administration to death.
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ME-344
Arm/Group Description	ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle. Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator. Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.
Measure Participants	41
Median (95% Confidence Interval) [months]	3.7

Adverse Events

Time Frame	The occurrence of adverse events was assessed throughout the trial, up to 13 months.
Adverse Event Reporting Description	Forty-six patients were enrolled in the trial and were to receive both ME-344 and topotecan. Forty-five subjects received both drugs, 1 subject received only ME-344
Arm/Group Title	ME-344
Arm/Group Description	ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle ME-344: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle. Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator. Topotecan: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.
All Cause Mortality
	ME-344
	Affected / at Risk (%)	# Events
Total	6/46 (13%)
Serious Adverse Events
	ME-344
	Affected / at Risk (%)	# Events
Total	17/46 (37%)
Blood and lymphatic system disorders
Febrile Neutropenia	2/46 (4.3%)	2
Thrombocytopenia	2/46 (4.3%)	2
Gastrointestinal disorders
Diarrhea	1/46 (2.2%)	1
Gastrointestinal Hemorrhage	1/46 (2.2%)	1
Intestinal obstruction	1/46 (2.2%)	1
Small intestinal obstruction	3/46 (6.5%)	3
Abdominal Pain	1/46 (2.2%)	1
General disorders
Fatique	1/46 (2.2%)	1
Infections and infestations
Bacteremia	1/46 (2.2%)	1
Neutropenic sepsis	1/46 (2.2%)	2
Pneumonia	1/46 (2.2%)	1
Sepsis	1/46 (2.2%)	1
Urinary tract infection	1/46 (2.2%)	1
Injury, poisoning and procedural complications
Procedural Pain	1/46 (2.2%)	1
Metabolism and nutrition disorders
Diabetic ketoacidosis	1/46 (2.2%)	1
Musculoskeletal and connective tissue disorders
Muscular weakness	1/46 (2.2%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/46 (2.2%)	2
Other (Not Including Serious) Adverse Events
	ME-344
	Affected / at Risk (%)	# Events
Total	46/46 (100%)
Blood and lymphatic system disorders
Neutropenia	21/46 (45.7%)	45
Thrombocytopenia	18/46 (39.1%)	33
Anaemia	16/46 (34.8%)	31
Gastrointestinal disorders
Nausea	22/46 (47.8%)	34
Diarrhoea	21/46 (45.7%)	25
Vomiting	18/46 (39.1%)	29
Constipation	15/46 (32.6%)	19
Abdominal pain	7/46 (15.2%)	12
Abdominal pain lower	3/46 (6.5%)	3
Dyspepsia	3/46 (6.5%)	3
Gastrooesophageal reflux disease	3/46 (6.5%)	3
General disorders
Fatigue	30/46 (65.2%)	42
Asthenia	7/46 (15.2%)	11
Chest pain	6/46 (13%)	10
Chest discomfort	5/46 (10.9%)	7
Muscosal inflammation	3/46 (6.5%)	5
Oedema peripheral	3/46 (6.5%)	3
Peripheral swelling	3/46 (6.5%)	3
Pyrexia	3/46 (6.5%)	4
Infections and infestations
Urinary tract infection	5/46 (10.9%)	5
Upper Respiratory Tract Infection	4/46 (8.7%)	4
Injury, poisoning and procedural complications
Infusion related reaction	4/46 (8.7%)	6
Investigations
Weight decreased	9/46 (19.6%)	12
White blood cell count decreased	6/46 (13%)	13
Neutrophil count decreased	5/46 (10.9%)	11
Platelet count decreased	5/46 (10.9%)	25
QTc Prolonged	3/46 (6.5%)	3
Metabolism and nutrition disorders
Decreased appetite	19/46 (41.3%)	20
Hypokalemia	6/46 (13%)	24
Dehydration	4/46 (8.7%)	4
Hypomagnesaemia	3/46 (6.5%)	4
Hyponatremia	3/46 (6.5%)	5
Musculoskeletal and connective tissue disorders
Arthralgia	8/46 (17.4%)	10
Back pain	8/46 (17.4%)	8
Muscle spasms	5/46 (10.9%)	6
Muscle weakness	3/46 (6.5%)	3
Myalgia	3/46 (6.5%)	5
Pain in extremity	3/46 (6.5%)	3
Nervous system disorders
Headache	6/46 (13%)	6
Dizziness	5/46 (10.9%)	5
Paraesthesia	4/46 (8.7%)	5
Psychiatric disorders
Anxiety	3/46 (6.5%)	3
Renal and urinary disorders
Dysuria	3/46 (6.5%)	3
Respiratory, thoracic and mediastinal disorders
Dyspnoea	8/46 (17.4%)	9
Cough	7/46 (15.2%)	7
Oropharyngeal pain	3/46 (6.5%)	4
Productive cough	3/46 (6.5%)	3
Skin and subcutaneous tissue disorders
Alopecia	4/46 (8.7%)	4
Dry skin	3/46 (6.5%)	3
Vascular disorders
Hypertension	19/46 (41.3%)	27

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Each PI has a CDA in place that restricts them from discussing the results of the clinical study at a scientific meeting or any other public or private forum or to publish in a scientific or academic journal the results of the clinical study without the approval of the Sponsor Company (MEI Pharma Inc.).