Know Cancer

or
forgot password

A Phase 1b Trial of LY2584702 in Combination With Erlotinib or Everolimus in Patients With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Metastases, Neoplasm, Carcinoma, Non-small Cell Lung, Renal Cell Carcinoma, Neuroendocrine Tumors

Thank you

Trial Information

A Phase 1b Trial of LY2584702 in Combination With Erlotinib or Everolimus in Patients With Solid Tumors


Study JGCB will consist of the following parts:

Part 1 - Dose Escalation to maximum tolerated dose in each arm.

Arm A - LY2584702 + Erlotinib in patients with advanced or metastatic cancer.

Arm B - LY2584702 + Everolimus in patients with advanced or metastatic cancer.

Part 2 - Dose Confirmation of maximum tolerated dose from each arm in Part 1.

Arm A - LY2584702 + Erlotinib in patients with advanced or metastatic non-small cell lung
cancer.

Arm B - LY2584702 + Everolimus in patients with advanced renal cell carcinoma after
treatment failure with sunitinib or sorafenib, or advanced neuroendocrine tumors.


Inclusion Criteria:



- Dose Escalation portion (Part 1): have histological or cytological evidence of a
diagnosis of cancer that is advanced and/or metastatic disease (including
Non-Hodgkin's Lymphoma) for which no proven effective therapy exists.

- Dose Confirmation portion (Part 2): have histological or cytological evidence of:

1. Arm A: advanced or metastatic non-small cell lung cancer after failure of at
least one prior chemotherapy regimen.

2. Arm B: advanced renal cell carcinoma after failure of treatment with sunitinib
or sorafenib, or advanced neuroendocrine tumors.

- 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.

1. Dose Escalation portion (Part 1): patients may have measurable or nonmeasurable
disease.

2. Dose Confirmation portion (Part 2): patients must have measurable disease.

- Have adequate organ function including:

1. 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.

2. Hepatic: bilirubin less than or equal to 1.5 times upper limits of normal (ULN);
alanine transaminase (ALT) and 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. Patients with bone metastases may enter with alkaline
phosphatase values less than or equal to 5 times ULN, as long as other hepatic
parameters meet inclusion criteria.

3. Renal: Serum creatinine less than or equal to 1.5 times ULN or calculated
creatinine clearance >45 ml/mn.

- Have a performance status of less than or equal to 1 on the Eastern Cooperative
Oncology Group (ECOG) scale.

- Have discontinued all previous therapies for cancer, including chemotherapy,
radiotherapy, cancer-related hormonal therapy, or other investigational therapy for
at least 2 weeks (3 weeks for myelosuppressive agents) prior to study enrollment, and
have recovered from the acute effects of therapy. At the discretion of the
investigator, patients with prostate cancers progressing under LHRH agonists therapy,
and patients with adrenal carcinomas using mitotan, may have that treatment continued
while receiving study drug.

Exclusion Criteria:

- Have received treatment with a drug that has not received regulatory approval for any
indication within 14 or 21 days of the initial dose of study drug for a
nonmyelosuppressive or myelosuppressive agent, respectively.

- Have serious preexisting medical conditions that, in the opinion of the investigator,
would preclude participation in this study.

- Have symptomatic CNS malignancy or metastasis. Patients with treated CNS metastases
are eligible provided their disease is radiographically stable and asymptomatic, and
they are not currently receiving corticosteroids and/or anticonvulsants. Screening of
asymptomatic patients without history of CNS metastasis is not required.

- Concomitant treatment by strong CYP3A4 inhibitors or CYP3A4 inducers.

- Have an acute or chronic leukemia.

- Have received an autologous or allogeneic stem-cell transplant within 75 days of the
initial dose of study drug. In addition, recipients of an allogenic stem-cell
transplant must have discontinued immunosuppressive therapy at least 24 hours before
study drug administration with no more than Grade 1 acute graft-versus-host disease.

- For Dose Confirmation portion (Part 2): have previously received erlotinib for Arm A
or everolimus for Arm B.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended dose for Phase 2 studies

Outcome Time Frame:

Baseline to study completion

Safety Issue:

Yes

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

12531

NCT ID:

NCT01115803

Start Date:

March 2010

Completion Date:

June 2011

Related Keywords:

  • Metastases, Neoplasm
  • Carcinoma, Non-Small Cell Lung
  • Renal Cell Carcinoma
  • Neuroendocrine Tumors
  • Advanced Cancer
  • Metastatic Cancer
  • Non-Small Cell Lung Cancer
  • Renal Cell Carcinoma
  • Neuroendocrine Tumors
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Neoplasm Metastasis
  • Neuroendocrine Tumors

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Chicago, Illinois  60674