Phase 1
N=35
A Dose Escalation, Dose Expansion Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, in Subjects With Advanced Tumors.
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00816400 ↗Enrolled (actual)
35
Serious AEs
37.1%
Results posted
Apr 2017
Primary outcome: Primary: Number of Participants With Adverse Events — 3; 3; 5; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MEDI-575 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
3; 3; 5; 3; 3; 3 | — |
| PRIMARY Number of Participants With Serious Adverse Events |
0; 1; 3; 0; 0; 1 | — |
| PRIMARY Treatment-emergent Adverse Events Related to Laboratory Parameters |
0; 0; 1; 1; 0; 1 | — |
| PRIMARY Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Treatment-emergent Adverse Events Related to Vital Sign Parameters |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Maximum Tolerated Dose (MTD) |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Pharmacokinetics (PK) of MEDI-575 After the First Dose: Observed Maximum Serum Concentration (Cmax) |
72.6; 154; 239; 590; 632; 670 | — |
| SECONDARY PK of MEDI-575 After the First Dose: Time to Maximum Concentration (Tmax) |
0.0759; 0.0479; 0.0618; 0.130; 0.106; 0.227 | — |
| SECONDARY PK of MEDI-575 After the First Dose: Dose-normalized Maximum Serum Concentration (Cmax/Dose) |
0.292; 0.402; 0.335; 0.638; 0.655; 0.360 | — |
| SECONDARY PK of MEDI-575 After the First Dose: Trough Serum Concentration (Ctrough) |
8.97; 41.5; 72.6; 144; 199; 85.4 | — |
| SECONDARY PK of MEDI-575 After the First Dose: Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCτ) |
201; 524; 835; 1870; 2080; 5100 | — |
| SECONDARY PK of MEDI-575 After the First Dose: Dose-normalized Area Under the Serum Concentration-time Curve (AUCτ/Dose) |
0.804; 1.36; 1.19; 2.01; 2.12; 2.78 | — |
| SECONDARY Number of Participants Positive for Anti-drug Antibodies Formation for MEDI-575 at Any Visit |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Percentage of Participants With Objective Response |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Time to Response |
— | — |
| SECONDARY Duration of Response |
— | — |
| SECONDARY Time to Progression |
1.8; 1.4; 1.2; 1.4; 5.0; 2.9 | — |
| SECONDARY Progression-free Survival |
1.8; 1.4; 1.2; 1.4; 5.0; 2.9 | — |
| SECONDARY Overall Survival |
9.0; 3.7; 17.2; 5.5; 19.4; 8.7 | — |
Summary
Evaluate the safety, tolerability and the tolerated maximum dose of MEDI-575 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed advanced solid tumor for which no curative or standard therapies exist
- Karnofsky performance status of ≥ 60
- Life expectancy of >12 weeks
- Adequate hematologic and organ function
- Negative serum pregnancy test (women only)
- Two methods of birth control for female participants of child-bearing potential or male participants with their female partners of child-bearing potential
Exclusion Criteria
- Prior chemotherapy or investigational treatment within 4 weeks of study drug administration
- Prior biological or immunological treatment within 6 weeks of study drug administration
- Concurrent therapy for of cancer
- Major surgery within four weeks or minor surgery within two weeks of study drug administration
- History of diabetes or current treatment for diabetes
- New York Heart Association ≥ Grade 2 congestive heart failure
- History of myocardial infarction, unstable angina, transient ischemic attack or stroke within the previous 6 months prior to study entry
- History of other invasive malignancy within 5 years (exceptions are cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that are surgically cured)
- Significant active infection
- Known brain metastases
- Pregnancy or lactation or plans to become pregnant while on study
- Clinically significant abnormality on ECG
Data sourced from ClinicalTrials.gov (NCT00816400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.