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A Study in Patients With Advanced or Metastatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01115751
First received: April 22, 2010
Last updated: July 30, 2012
Last verified: July 2012
April 22, 2010
July 30, 2012
March 2010
July 2012   (Final data collection date for primary outcome measure)
Recommended dose for Phase 2 Studies [ Time Frame: Baseline to study completion ]
Same as current
Complete list of historical versions of study NCT01115751 on ClinicalTrials.gov Archive Site
  • Clinically significant effects [ Time Frame: Baseline to study completion ]
  • Pharmacokinetics, area under the concentration-time curve [ Time Frame: Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2 ]
  • Best overall response (CR+PR+SD) [ Time Frame: Baseline to measured disease progression. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period. ]
  • Progression-free survival [ Time Frame: Baseline to measured disease progression or death. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period. ]
  • Duration of response [ Time Frame: 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. ]
  • Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2 ]
Same as current
Not Provided
Not Provided
 
A Study in Patients With Advanced or Metastatic Cancer
A Phase I Trial of Single-Agent LY2780301 in Patients With Advanced or Metastatic Cancer
Study JWAA is a multicenter, nonrandomized, open-label, dose-escalation Phase 1 study of oral LY2780301 in patients with advanced solid tumors.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastases, Neoplasm
Drug: LY2780301

Administered orally, daily for two 28-day cycles.

Starting dose is 100mg. The dose will be subsequently increased to 200mg, 300mg, 400mg, 500mg, and 600mg if no dose limiting toxicity is observed at the prior dose levels. Patients who, in the opinion of the investigator, demonstrate clinical benefit may receive treatment beyond two cycles until disease progression.

Experimental: LY2780301

Part A: daily dosing

Part B (if determined as needed by pharmacokinetic, pharmacodynamic, and safety data): twice daily dosing

Part C: Dose and frequency as determined by Parts A and B of the study.

Intervention: Drug: LY2780301
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
July 2012
July 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01115751
13127
I4H-MC-JWAA ( Other Identifier: Eli Lilly and Company )
No
Not Provided
Not Provided
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP