Trial Outcomes & Findings for Phase 1 Clinical Trial MPC-2130 Treatment of Blood Cancers / Refractory Cancer (NCT NCT00387153)

Last Updated: 2009-11-03

Results Overview

Dose limiting toxicities include any grade 3 nonhematological toxicity(excluding nausea/vomiting or alopecia); greater than grade 3 nausea/vomiting uncontrolled by aggressive antiemetic support; grade 4 neutropenia lasting more than 5 days, or any febrile (38.5° C or 101° F) grade 3/4 neutropenia; grade 4 thrombocytopenia. An adverse event is any reaction, side effect, or other untoward event, regardless of relationship to MPC-2130 that occurs any time after the beginning of the first IV infusion of MPC-2130 until 30 days after MPC-2130 discontinuation.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

8 participants

Primary outcome timeframe

First 21 days on treatment (Cycle 1)

Results posted on

2009-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	MPC-2130 Group 1 Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
Overall Study STARTED	8
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	MPC-2130 Group 1 Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
Overall Study Adverse Event	1
Overall Study Disease Progression	3
Overall Study Lack of Response	4

Baseline Characteristics

Phase 1 Clinical Trial MPC-2130 Treatment of Blood Cancers / Refractory Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MPC-2130 Group 1 n=8 Participants Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age Continuous	48.5 years STANDARD_DEVIATION 21.9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: First 21 days on treatment (Cycle 1)

Population: A total of 8 subjects were enrolled in the study. Statistical analyses were intended to be descriptive since the goal for the study was to determine the maximum tolerated dose and general safety and tolerability of MPC-2130.

Outcome measures

Outcome measures
Measure	MPC-2130 Group 1 n=8 Participants Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
Number of Subjects With Dose Limiting Toxicities and Grade 3/4 Adverse Events. As a General Guideline, a Severe Adverse Event is Considered Grade 3, and a Life Threatening or Disabling Adverse Event is Considered Grade 4.	8 Participants

PRIMARY outcome

Timeframe: First 5 days of treatment (Cycle 1)

Characterization of MPC-2130 pharmamcokinetics consisting of AUC, tmax, Cmax, half-life and clearance.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 42 days

Observation for any evidence of antiproliferative activity of MPC-2130 in treatment of a variety ofrefractory neoplasias.

Outcome measures

Outcome data not reported

Adverse Events

MPC-2130 Group 1

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MPC-2130 Group 1 n=8 participants at risk Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
Cardiac disorders sinus bradycardia	12.5% 1/8 • Number of events 1
Blood and lymphatic system disorders disease progression	12.5% 1/8 • Number of events 1
Respiratory, thoracic and mediastinal disorders pleural effusion	12.5% 1/8 • Number of events 1

Other adverse events

Other adverse events
Measure	MPC-2130 Group 1 n=8 participants at risk Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
Blood and lymphatic system disorders blood and lymphatic system disorders	62.5% 5/8 • Number of events 6
Cardiac disorders Cardiac disorders	25.0% 2/8 • Number of events 2
Gastrointestinal disorders gastroinstestinal disorders	87.5% 7/8 • Number of events 17
General disorders general disorders and administration site conditions	75.0% 6/8 • Number of events 16
Hepatobiliary disorders hepatobiliary disorders	12.5% 1/8 • Number of events 1
Immune system disorders immune system disorders	12.5% 1/8 • Number of events 1
Infections and infestations infection and infestations	50.0% 4/8 • Number of events 7
Injury, poisoning and procedural complications contusion	12.5% 1/8 • Number of events 1
Investigations investigations	87.5% 7/8 • Number of events 8
Metabolism and nutrition disorders metabolism and nutrition disorders	100.0% 8/8 • Number of events 23
Musculoskeletal and connective tissue disorders back pain	12.5% 1/8 • Number of events 1
Musculoskeletal and connective tissue disorders muscular weakness	12.5% 1/8 • Number of events 1
Nervous system disorders nervous system disorders	87.5% 7/8 • Number of events 16
Psychiatric disorders psychiatric disorders	62.5% 5/8 • Number of events 9
Respiratory, thoracic and mediastinal disorders respiratory, thoracic and mediastinal disorders	37.5% 3/8 • Number of events 7
Skin and subcutaneous tissue disorders skin and subcutaneous tissue disorders	62.5% 5/8 • Number of events 6
Vascular disorders vascular disorders	62.5% 5/8 • Number of events 6

Additional Information

Richard Wenstrup, MD, VP Chief Medical Officer

Myriad Therapeutics, Inc.

Phone: 801-584-3009

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor has the right to the 1st publication within 12 months of study conclusion. After, the institution/PI may publish data after submission to the sponsor for review.
Publication restrictions are in place

Restriction type: OTHER