Phase 1
Completed N=27
A Study of LY3007113 in Participants With Advanced Cancer
Source: ClinicalTrials.gov NCT01463631 ↗Enrolled (actual)
27
Serious AEs
33.3%
Results posted
Aug 2018
Primary outcomePrimary: Number of Participants With Clinically Significant Adverse Events (AEs) (Physical Assessments and Clinical Lab Tests) — 2; 4; 4; 8 Participants
Summary
This study evaluates the safety and tolerability of different doses of an experimental treatment in participants with advanced cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Significant Adverse Events (AEs) (Physical Assessments and Clinical Lab Tests) |
2; 4; 4; 8 | — |
| SECONDARY The Percentage of Participants Who Achieved a Best Response of Either Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR) |
0; 0 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of Single Dose LY3007113 |
1560; 2480; 1810 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration Versus Time Curve From 0 to Tau (AUC[0-tau]) of Multiple Dose LY3007113 |
1360; 3260; 2070 | — |
| SECONDARY Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3007113 |
197; 296; 247; 178; 489; 386 | — |
Eligibility Criteria
Inclusion Criteria
- Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic for which available standard therapies have failed to provide clinical benefit for their disease
- For Dose Escalation (Part A): cancer, either a solid tumor or a lymphoma
- For Dose Confirmation (Part B): cancer, either a solid tumor or a lymphoma
- Have the presence of measureable or non-measureable disease (Part A) or measureable disease (Part B) as defined by the Response Evaluation Criteria in Solid Tumors or the Revised Response Criteria for Malignant Lymphoma
- Have adequate hematologic, hepatic and renal function
- Have a performance status less than or equal to 2 on the Eastern Cooperative Oncology Group scale
- Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents
- Have an estimated life expectancy of greater than or equal to 12 weeks
- Are able to swallow capsules
Exclusion Criteria
- Have an echocardiogram with clinically significant abnormalities
- For Dose Escalation (Part A): Have central nervous system malignancy or metastasis
- For Dose Confirmation (Part B): Have symptomatic central nervous system malignancy or metastasis
- Have an acute leukemia
- Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and stopped all therapy for that disease for a minimum of 3 years
- Have received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug
Data sourced from ClinicalTrials.gov (NCT01463631). 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.