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A Phase 1b/2 Double-Blind Randomized Trial of the Hedgehog/SMO Antagonist LY2940680 in Combination With Carboplatin and Etoposide Followed by LY2940680 Versus Carboplatin and Etoposide Plus Placebo Followed by Placebo in Patients With Extensive-Stage Small Cell Lung Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Small Cell Lung Carcinoma

Thank you

Trial Information

A Phase 1b/2 Double-Blind Randomized Trial of the Hedgehog/SMO Antagonist LY2940680 in Combination With Carboplatin and Etoposide Followed by LY2940680 Versus Carboplatin and Etoposide Plus Placebo Followed by Placebo in Patients With Extensive-Stage Small Cell Lung Cancer


Inclusion Criteria:



- Histological or cytological diagnosis of Small Cell Lung Cancer (SCLC), including
malignant pleural effusion that is extensive stage per the International Staging
System

- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG)
performance status schedule

- No prior systemic chemotherapy, immunotherapy, or biological therapy for SCLC

- Prior radiation therapy allowed to <25% of the bone marrow. Participants who have
received prior radiation to the whole pelvis or chest for the treatment of SCLC are
not eligible

- At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in
Solid Tumors (RECIST) version 1.1

- Adequate organ function including the following:

- Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥1.5 x 10^9/ liter
(L), platelets ≥100 x 10^9/L, and hemoglobin ≥9 grams/deciliter (g/dL)

- Hepatic: bilirubin ≤1.5 times the upper limit of normal (ULN), alkaline
phosphatase (AP), Serum alanine aminotransferase (ALT) and aspartate
transaminase (AST) ≤3.0 x ULN (AP, AST, and ALT ≤5 x ULN is acceptable if liver
has tumor involvement)

- Renal: calculated creatinine clearance (CrCl) ≥50 milliliters per minute
(mL/min) based on the standard Cockcroft and Gault formula

- Estimated life expectancy of at least 12 weeks

- For women: Must be surgically sterile, post-menopausal, or compliant with a medically
approved contraceptive regimen during and for 6 months after the treatment period;
must have a negative serum pregnancy test within 7 days before study enrollment. For
men: Must be surgically sterile or compliant with a contraceptive regimen during and
for 6 months after the treatment period

- Availability of a tumor tissue sample

- Able to swallow capsules

Exclusion Criteria:

- Currently enrolled in, or discontinued within the last 30 days from, a clinical trial
involving an investigational product or non-approved use of a drug or device, or
concurrently enrolled in any other type of medical research judged not to be
scientifically or medically compatible with this study

- Have previously participated in a study involving LY2940680

- Have previously received treatment with carboplatin or etoposide

- Have a mixed histological diagnosis of SCLC and Non-Small Cell Lung Cancer (NSCLC)

- Have a serious concomitant systemic disorder that, in the opinion of the
investigator, would compromise the participant's ability to adhere to the protocol

- Have an active infection [≥38.5 degrees Celsius and/or receiving Intravenous (IV)
antibiotic therapy]

- Have a serious cardiac condition

- Have had a prior malignancy other than SCLC, carcinoma in situ of the cervix, or
nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively
treated at least 5 years previously with no subsequent evidence of recurrence.
Participants with a history of non-metastatic prostate cancer, including biochemical
relapse only, will be eligible even if diagnosed less than 5 years previously

- Symptomatic central nervous system (CNS) metastases and asymptomatic CNS metastases
requiring concurrent corticosteroid therapy. Treated stable CNS metastases are
allowed; the participant must be stable after radiotherapy for ≥2 weeks and off of
corticosteroids for ≥1 week

- Presence of clinically significant third-space fluid collections that cannot be
controlled prior to study entry

- Significant weight loss (that is, ≥10%) over the 6-week period prior to study entry

- Concurrent administration of any other antitumor therapy. An exception will be made
for non-metastatic prostate cancer participants continuing androgen blockade therapy
only or breast cancer participants continuing adjuvant antiestrogen therapy only (for
example, an aromatase inhibitor)

- Females who are breastfeeding

- Have corrected QT interval (QTc) of >470 millisecond (msec) on screening
electrocardiogram (ECG)

- Have received medications that are strong inhibitors of Cytochrome P450 3A4 (CYP3A4)
within 7 days prior to receiving study drug

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Phase 1b: Recommended Phase 2 Dose of LY2940680

Outcome Time Frame:

Baseline to Completion of the Phase 1b Portion (Estimated as 9 Months)

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM 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:

14631

NCT ID:

NCT01722292

Start Date:

January 2013

Completion Date:

February 2017

Related Keywords:

  • Small Cell Lung Carcinoma
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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.Manhassaet, New York  
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.Phoenix, Arizona  85012
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.Jacksonville, Florida  32256
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.Athens, Georgia  30607
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
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.Kalamazoo, Michigan  49048
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.Las Vegas, Nevada  89169
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.Dunmore, Pennsylvania  18512
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.Greenville, South Carolina  29605
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.Memphis, Tennessee  38138
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.Bedford, Texas  76022
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.Norfolk, Virginia  23502
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.Seattle, Washington  98133
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.Little Rock, Arkansas  72205
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.Springfield, Massachusetts  
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.Cheyenne, Wyoming  82001