Phase 1
Completed N=29
A Study of LY3164530 in Participants With Cancer
Neoplasms · Neoplasm Metastasis
Source: ClinicalTrials.gov NCT02221882 ↗
Enrolled (actual)
29
Serious AEs
13.8%
Results posted
Oct 2019
Primary outcomePrimary: Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD) — 1000; 500 milligrams (mg)
Summary
The main purpose of this study is to evaluate the safety of a study drug known as LY3164530 in participants with cancer that is advanced and/or has spread to another part(s) of the body.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD) |
1000; 500 | — |
| SECONDARY Maximum Serum Concentration (Cmax) of LY3164530 Epidermal Growth Factor Receptor (EGFR) Specific ELISA Assay |
85.1; 122; 367; 496; 226; 255 | — |
| SECONDARY Maximum Serum Concentration (Cmax) of LY3164530 Mesenchymal-Epithelial Transition Factor (MET) Specific ELISA Assay |
82.5; 124; 365; 498; 208; 221 | — |
| SECONDARY Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 EGFR Specific ELISA Assay |
5580; 9870; 37000; 57500; 16700; 19800 | — |
| SECONDARY Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 MET Specific ELISA Assay |
6150; 10900; 37500; 57300; 16300; 17500 | — |
| SECONDARY Number of Participants With Tumor Response |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Have advanced or metastatic cancer and be an appropriate candidate for experimental therapy.
- Have adequate organ function.
- Prior Treatments:
- Systemic treatments: Must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued:
- Cytotoxic therapies or targeted agents that are small molecule inhibitors for 5 half-lives or at least 28 days.
- Mitomycin-C or nitrosourea therapy for at least 42 days and biologic agents for at least 28 days.
- Radiation therapy and surgery must be completed 4 weeks prior to therapy, except for limited field radiation therapy, which must be completed 2 weeks before therapy.
- If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug.
- If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding.
Exclusion Criteria
- Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment.
- Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C.
- Must not have a serious preexisting medical conditions or concomitant disorders.
- Must not have leukemia.
- Must not have QT interval of >470 millisecond.
- Must not have a serious cardiac condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last 3 months.
Data sourced from ClinicalTrials.gov (NCT02221882). 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. Informational only — not medical advice.