Cancer
Conditions
Keywords
Oncology, Cancer, Blood Cancers
Brief summary
Phase 1 Open-label treatment with MPC-2130 for subjects with refractory cancer.
Detailed description
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.
Interventions
DRUGMPC-2130
MPC-2130 10 mg/mL administered by intravenous infusion over 1-2 hours
Sponsors
Myriad Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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; 2. Have cancer that is nonresponsive despite prior treatment with current standard of care regimens or for whom there are no available effective therapies; 3. Have measurable or evaluable neoplastic disease; 4. Be greater than or equal to age 18; 5. Have and ECOG Performance Status score of less than or equal to 2; 6. Have adequate organ function defined by: 1. Liver function tests (AST & ALT) less than or equal to 3 times the upper limit of normal (ULN); 2. Bilirubin less than or equal to 1.5 X ULN; 3. Serum Creatinine less than or equal to 1.5 X ULN; 4. Hemoglobin greater than or equal to 8.0 g/dL; 7. Have recovered or stabilized from clinically significant toxicities of prior chemotherapy, surgery, or radiotherapy; 8. Have left ventricular ejection fraction (LVEF) of greater than or equal to 45% by multiple gated acquisition (MUGA) scan or echocardiogram.
Exclusion criteria
1. Have had a prior serious, uncontrollable hypersensitivity reaction to Cremophor EL; 2. Be pregnant or lactating (women of childbearing potential must use appropriate birth control (abstinence, barrier methods, oral contraceptives and/or intrauterine devices) during the entire duration of the study, or the patient must be surgically sterile (with documentation in the patient's medical records); 3. Receive any other anticancer treatment or investigational therapy within 14 days prior to day 1; or within 6 weeks after prior mitomycin C or nitrosourea. Patients with advanced prostate cancer may continue to receive leutinizing hormone-releasing hormone (LHRH) therapy while in this study; 4. Have previously enrolled in this trial. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | First 21 days on treatment (Cycle 1) | 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. |
| Pharmacokinetics | First 5 days of treatment (Cycle 1) | Characterization of MPC-2130 pharmamcokinetics consisting of AUC, tmax, Cmax, half-life and clearance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antiproliferative Activity | Every 42 days | Observation for any evidence of antiproliferative activity of MPC-2130 in treatment of a variety ofrefractory neoplasias. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MPC-2130 Group 1 Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Disease Progression | 3 |
| Overall Study | Lack of Response | 4 |
Baseline characteristics
| Characteristic | MPC-2130 Group 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age Continuous | 48.5 years STANDARD_DEVIATION 21.9 |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 8 |
| serious Total, serious adverse events | 3 / 8 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MPC-2130 Group 1 | 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
Pharmacokinetics
Characterization of MPC-2130 pharmamcokinetics consisting of AUC, tmax, Cmax, half-life and clearance.
Time frame: 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.
Time frame: Every 42 days