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A Phase 1b/2 Study of OMP-59R5 in Combination With Etoposide and Cisplatin in Subjects With Untreated Extensive Stage Small Cell Lung Cancer (PINNACLE)


Phase 1/Phase 2
18 Years
90 Years
Open (Enrolling)
Both
Stage IV Small Cell Lung Cancer

Thank you

Trial Information

A Phase 1b/2 Study of OMP-59R5 in Combination With Etoposide and Cisplatin in Subjects With Untreated Extensive Stage Small Cell Lung Cancer (PINNACLE)


Inclusion Criteria:



Subjects must meet all of the following criteria to be eligible for the study:

1. Histologically or cytologically documented extensive stage small cell lung cancer.

2. Adults of 18 years of age or older.

3. Performance Status (ECOG) of 0 or 1.

4. FFPE tumor tissue.

5. Adequate organ function:

6. Written consent on an IRB/IEC-approved Informed Consent Form prior to any
study-specific evaluation.

7. For women of child-bearing potential, negative serum pregnancy test at screening and
use of physician-approved method of birth control from 30 days prior to the first
study drug administration to 30 days following the last study drug administration or
the last EP in the study, whichever is discontinued last.

8. Male subjects must be surgically sterile or must agree to use physician-approved
contraception during the study and for 30 days following the last study drug
administration or the last EP in the study, whichever is discontinued last.

Exclusion Criteria:

Subjects who meet any of the following criteria will not be eligible for participation in
the study:

1. Limited stage small cell lung cancer appropriate for radical treatment with
chemoradiation.

2. Prior therapy including radiation, chemotherapy or surgery for newly diagnosed
extensive stage small cell lung cancer.

3. Presence of any serious or uncontrolled illness including, but not limited to:
ongoing or active infection, symptomatic congestive heart failure unstable angina
pectoris, uncontrolled cardiac arrhythmia, uncontrolled arterial thrombosis,
symptomatic pulmonary embolism, and psychiatric illness that would limit compliance
with study requirement.

4. History of myocardial infarction, acute coronary syndromes (including unstable
angina), coronary angioplasty and/or stenting within 6 months prior to the first
administration of study drug.

5. A history of malignancy with the exception of:

1. Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or
in situ cervical cancer

2. Adequately treated stage I cancer from which the subject is currently in
remission, or

3. Any other cancer from which the subject has been disease-free for ≥ 3 years

6. Known human immunodeficiency virus (HIV) infection.

7. Females who are pregnant or breastfeeding.

8. Concurrent use of therapeutic warfarin (prophylactic low dose of warfarin, i.e., 1 mg
daily for port catheter is allowed)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Dose limiting toxicities (DLT) of OMP-59R5 in combination with Etoposide and Cisplatin

Outcome Description:

The maximum tolerated dose (MTD) will be determined in pts treated with OMP-59R5 in combination with etoposide and cisplain

Outcome Time Frame:

Subjects will be treated and observed for DLT through the end of the first cycle (28 days)

Safety Issue:

Yes

Principal Investigator

Lowell L. Hart, M.D., F.A.C.P.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Florida Cancer Specialists & Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

59R5-003

NCT ID:

NCT01859741

Start Date:

May 2013

Completion Date:

July 2017

Related Keywords:

  • Stage IV Small Cell Lung Cancer
  • Newly diagnosed Stage IV Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Rocky Mountain Cancer CentersThornton, Colorado  80260
Florida Cancer Specialists & Research InstituteGainsville, Florida  32605