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Last subject enrolled experienced bradycardia; study was terminated by Sponsor.
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Phase 1 Open-label treatment with MPC-2130 for subjects with refractory cancer.
MPC-2130 Phase 1 Clinical study was designed to evaluate its safety and pharmacokinetic profile in patients with advanced metastatic tumors or blood cancers as well as refractory cancers that progressed despite previous chemotherapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MPC-2130 | Drug | MPC-2130 10 mg/mL administered by intravenous infusion over 1-2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | First 21 days on treatment (Cycle 1) |
| Pharmacokinetics | Characterization of MPC-2130 pharmamcokinetics consisting of AUC, tmax, Cmax, half-life and clearance. | First 5 days of treatment (Cycle 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Antiproliferative Activity | Observation for any evidence of antiproliferative activity of MPC-2130 in treatment of a variety ofrefractory neoplasias. | Every 42 days |
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Inclusion Criteria:
Be capable of understanding the informed consent form (ICF) and complying with the protocol, and must sign the ICF prior to the performance of any study related procedures;
Have cancer that is nonresponsive despite prior treatment with current standard of care regimens or for whom there are no available effective therapies;
Have measurable or evaluable neoplastic disease;
Be greater than or equal to age 18;
Have and ECOG Performance Status score of less than or equal to 2;
Have adequate organ function defined by:
Have recovered or stabilized from clinically significant toxicities of prior chemotherapy, surgery, or radiotherapy;
Have left ventricular ejection fraction (LVEF) of greater than or equal to 45% by multiple gated acquisition (MUGA) scan or echocardiogram.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Wenstrup, MD | Myriad Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | MPC-2130 Group 1 | Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MPC-2130 Group 1 | Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | 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. | Posted | Number | Participants | First 21 days on treatment (Cycle 1) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MPC-2130 Group 1 | Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sinus bradycardia | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| blood and lymphatic system disorders | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Wenstrup, MD, VP Chief Medical Officer | Myriad Therapeutics, Inc. | 801-584-3009 | rwenstru@myriad.com |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG000 | MPC-2130 Group 1 | Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period. |
|
|
| Primary | Pharmacokinetics | Characterization of MPC-2130 pharmamcokinetics consisting of AUC, tmax, Cmax, half-life and clearance. | Not Posted | First 5 days of treatment (Cycle 1) |
| Secondary | Antiproliferative Activity | Observation for any evidence of antiproliferative activity of MPC-2130 in treatment of a variety ofrefractory neoplasias. | Not Posted | Every 42 days |
| 3 |
| 8 |
| 8 |
| 8 |
| disease progression | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cardiac disorders | Cardiac disorders | Non-systematic Assessment |
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| gastroinstestinal disorders | Gastrointestinal disorders | Non-systematic Assessment |
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| general disorders and administration site conditions | General disorders | Non-systematic Assessment |
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| hepatobiliary disorders | Hepatobiliary disorders | Non-systematic Assessment |
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| immune system disorders | Immune system disorders | Non-systematic Assessment |
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| infection and infestations | Infections and infestations | Non-systematic Assessment |
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| contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| investigations | Investigations | Non-systematic Assessment |
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| metabolism and nutrition disorders | Metabolism and nutrition disorders | Non-systematic Assessment |
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| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| muscular weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| nervous system disorders | Nervous system disorders | Non-systematic Assessment |
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| psychiatric disorders | Psychiatric disorders | Non-systematic Assessment |
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| respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| vascular disorders | Vascular disorders | Non-systematic Assessment |
|
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.