Clinical trial NCT01115751: A Study in Patients With Advanced or Metastatic Cancer
Official title: A Phase I Trial of Single-Agent LY2780301 in Patients With Advanced or Metastatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastases, Neoplasm
Keywords: Advanced Cancer
Metastatic Cancer
Solid Tumors
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study JWAA is a multicenter, nonrandomized, open-label, dose-escalation Phase 1 study of oral LY2780301 in patients with advanced solid tumors.

Detailed description: JWAA will consist of the following treatment phases parts:

Part A - Dose escalation phase using a once-daily dosing schedule. Part B - Dose escalation phase using a twice-daily dosing schedule. Part C - Dose expansion phase using the maximum tolerated dose from either Part A or Part B.

Eligibility criteria: Inclusion Criteria:

* Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic (including Non-Hodgkin's Lymphoma). The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their disease.
* Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or the Revised Response Criteria for Malignant Lymphoma.

Parts A and B: have measurable or nonmeasurable disease. Part C: have measurable disease.

* Have adequate organ function, including:

  * Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L, platelets greater than or equal to 100 x 109/L, and hemoglobin greater than or equal to 8 g/dL. Transfusions are not allowed to reach 8 g/dL prior to enrollment.
  * Hepatic: Bilirubin less than or equal to 1.5 times upper limits of normal (ULN), alanine aminotransaminase (ALT), and aspartate aminotransaminase (AST) less than or equal to 2.5 times ULN. If the liver has tumor involvement, AST and ALT equaling less than or equal to 5 times ULN are acceptable.
  * Renal: Serum creatinine less than or equal to 1.5 times ULN or calculated creatinine clearance greater than 45 ml/mn.
* Have a performance status of less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Have discontinued previous treatments for cancer and recovered from the acute effects of therapy: at least 28 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents. At the discretion of the investigator, hormone-refractory prostate cancer patients who are stable on gonadotropin-releasing hormone (GnRH) agonist therapy may have that treatment continued while they are enrolled in this study.

Exclusion Criteria:

* Have received treatment within 28 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication.
* Have serious preexisting medical conditions (left to the discretion of the investigator).
* Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Patients with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 60 days.
* Have current acute or chronic leukemia.
* Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
* Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results.
* Have QTc interval of \>470 msec on screening electrocardiogram(ECG).
* Treatment with a strong CYP3A4 substrate with narrow therapeutic range, strong inhibitor, or inducer.
* Have history of pituitary adenoma.

Primary outcomes:
measure: Recommended dose for Phase 2 Studies
timeFrame: Baseline to study completion
Secondary outcomes:
measure: Clinically significant effects
timeFrame: Baseline to study completion
measure: Pharmacokinetics, area under the concentration-time curve
timeFrame: Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2
measure: Best overall response (CR+PR+SD)
timeFrame: Baseline to measured disease progression. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.
measure: Progression-free survival
timeFrame: Baseline to measured disease progression or death. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.
measure: Duration of response
timeFrame: Time of response to disease progression or death. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.
measure: Pharmacokinetics, maximum concentration (Cmax)
timeFrame: Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Madrid
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: