Trial Outcomes & Findings for ME-344 Given in Combination With Hycamtin® in Patients With Solid Tumors (NCT NCT02100007)
NCT ID: NCT02100007
Last Updated: 2017-10-02
Results Overview
The AE Profile will be determined by the number of AEs regardless of severity
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Through study completion- an average of 2 years
Results posted on
2017-10-02
Participant Flow
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.
Fifty-eight (58) potential participants were screened; 46 subjects passed screening and were enrolled in the study.
Participant milestones
| Measure |
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
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 Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ME-344 Given in Combination With Hycamtin® in Patients With Solid Tumors
Baseline characteristics by cohort
| Measure |
ME-344
n=46 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
59.5 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion- an average of 2 yearsPopulation: 46 subjects received \> 2 doses of ME-344 and topotecan and were eligible for DLT analysis.
The AE Profile will be determined by the number of AEs regardless of severity
Outcome measures
| Measure |
ME-344
n=46 Participants
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.
|
|---|---|
|
Number of Adverse Events
|
595 adverse events
|
PRIMARY outcome
Timeframe: Through study completion- an average of 2 yearsPopulation: 46 subjects received \> 2 doses of ME-344 and topotecan and were eligible for DLT analysis.
The SAE Profile will be determined by the number of SAEs
Outcome measures
| Measure |
ME-344
n=46 Participants
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.
|
|---|---|
|
Number of Serious Adverse Events
|
23 SAEs
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusionPopulation: 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.
Peak Plasma Concentration (Cmax) of ME-344 in combination with topotecan
Outcome measures
| Measure |
ME-344
n=12 Participants
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.
|
|---|---|
|
Maximum Plasma Concentration (Cmax)
|
20880 ng/mL
Standard Deviation 8201.3
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusionPopulation: 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
Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.
Outcome measures
| Measure |
ME-344
n=13 Participants
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.
|
|---|---|
|
Time to Maximum Plasma Concentration for ME-344 (Tmax)
|
0.5 hours
Interval 0.48 to 2.02
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusionPopulation: 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.
Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.
Outcome measures
| Measure |
ME-344
n=13 Participants
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.
|
|---|---|
|
Minimum Plasma Concentration (Cmin) of ME-344
|
25.3 ng/mL
Standard Deviation 12.824
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusionPopulation: 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.
Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.
Outcome measures
| Measure |
ME-344
n=13 Participants
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.
|
|---|---|
|
Mean Terminal Half-life (t 1/2)
|
5.301 hours
Standard Deviation 2.0114
|
SECONDARY outcome
Timeframe: Response was assessed throughout the trial up to 13 monthsPopulation: Part 1 (N =12), Part 2 (N=29)
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.
Outcome measures
| Measure |
ME-344
n=41 Participants
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.
|
|---|---|
|
Estimate Overall Response Rate for ME-344 Given in Combination With Topotecan
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 2 years41 subjects were analysed. Overall survival is defined as the first day of study drug administration to death.
Outcome measures
| Measure |
ME-344
n=41 Participants
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.
|
|---|---|
|
Estimate the Overall Survival (OS)
|
3.7 months
Interval 2.8 to 5.4
|
Adverse Events
ME-344
Serious events: 17 serious events
Other events: 46 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
ME-344
n=46 participants at risk
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.
|
|---|---|
|
Injury, poisoning and procedural complications
Procedural Pain
|
2.2%
1/46 • Number of events 1 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
1/46 • Number of events 2 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
4.3%
2/46 • Number of events 2 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.3%
2/46 • Number of events 2 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
General disorders
Fatique
|
2.2%
1/46 • Number of events 1 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/46 • Number of events 1 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
2.2%
1/46 • Number of events 1 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.2%
1/46 • Number of events 1 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.2%
1/46 • Number of events 1 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
2.2%
1/46 • Number of events 1 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Infections and infestations
Bacteremia
|
2.2%
1/46 • Number of events 1 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Infections and infestations
Neutropenic sepsis
|
2.2%
1/46 • Number of events 2 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Infections and infestations
Pneumonia
|
2.2%
1/46 • Number of events 1 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Infections and infestations
Sepsis
|
2.2%
1/46 • Number of events 1 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/46 • Number of events 1 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
6.5%
3/46 • Number of events 3 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.2%
1/46 • Number of events 1 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
Other adverse events
| Measure |
ME-344
n=46 participants at risk
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.
|
|---|---|
|
Vascular disorders
Hypertension
|
41.3%
19/46 • Number of events 27 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
General disorders
Fatigue
|
65.2%
30/46 • Number of events 42 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
General disorders
Asthenia
|
15.2%
7/46 • Number of events 11 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
General disorders
Chest pain
|
13.0%
6/46 • Number of events 10 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
General disorders
Chest discomfort
|
10.9%
5/46 • Number of events 7 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
General disorders
Muscosal inflammation
|
6.5%
3/46 • Number of events 5 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
General disorders
Oedema peripheral
|
6.5%
3/46 • Number of events 3 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
General disorders
Peripheral swelling
|
6.5%
3/46 • Number of events 3 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
General disorders
Pyrexia
|
6.5%
3/46 • Number of events 4 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Psychiatric disorders
Anxiety
|
6.5%
3/46 • Number of events 3 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
8.7%
4/46 • Number of events 6 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Investigations
Weight decreased
|
19.6%
9/46 • Number of events 12 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Investigations
White blood cell count decreased
|
13.0%
6/46 • Number of events 13 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Investigations
Neutrophil count decreased
|
10.9%
5/46 • Number of events 11 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Investigations
Platelet count decreased
|
10.9%
5/46 • Number of events 25 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Investigations
QTc Prolonged
|
6.5%
3/46 • Number of events 3 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Blood and lymphatic system disorders
Neutropenia
|
45.7%
21/46 • Number of events 45 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
39.1%
18/46 • Number of events 33 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Blood and lymphatic system disorders
Anaemia
|
34.8%
16/46 • Number of events 31 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.4%
8/46 • Number of events 9 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.2%
7/46 • Number of events 7 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.5%
3/46 • Number of events 4 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.5%
3/46 • Number of events 3 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Nervous system disorders
Headache
|
13.0%
6/46 • Number of events 6 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Nervous system disorders
Dizziness
|
10.9%
5/46 • Number of events 5 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Nervous system disorders
Paraesthesia
|
8.7%
4/46 • Number of events 5 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Gastrointestinal disorders
Nausea
|
47.8%
22/46 • Number of events 34 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Gastrointestinal disorders
Diarrhoea
|
45.7%
21/46 • Number of events 25 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Gastrointestinal disorders
Vomiting
|
39.1%
18/46 • Number of events 29 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Gastrointestinal disorders
Constipation
|
32.6%
15/46 • Number of events 19 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Gastrointestinal disorders
Abdominal pain
|
15.2%
7/46 • Number of events 12 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.5%
3/46 • Number of events 3 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
3/46 • Number of events 3 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.5%
3/46 • Number of events 3 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Renal and urinary disorders
Dysuria
|
6.5%
3/46 • Number of events 3 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.7%
4/46 • Number of events 4 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.5%
3/46 • Number of events 3 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.4%
8/46 • Number of events 10 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.4%
8/46 • Number of events 8 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.9%
5/46 • Number of events 6 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
6.5%
3/46 • Number of events 3 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
3/46 • Number of events 5 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
3/46 • Number of events 3 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Metabolism and nutrition disorders
Decreased appetite
|
41.3%
19/46 • Number of events 20 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.0%
6/46 • Number of events 24 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Metabolism and nutrition disorders
Dehydration
|
8.7%
4/46 • Number of events 4 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.5%
3/46 • Number of events 4 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.5%
3/46 • Number of events 5 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Infections and infestations
Urinary tract infection
|
10.9%
5/46 • Number of events 5 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.7%
4/46 • Number of events 4 • The occurrence of adverse events was assessed throughout the trial, up to 13 months.
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
|
Additional Information
Richard Ghalie, MD, Sr Vice President Clinical Development
MEI Pharma Inc
Phone: 858 369-7116
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.).
- Publication restrictions are in place
Restriction type: OTHER