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An Open-Label Randomized Phase II Trial Comparing Gemcitabine and Carboplatin With and Without P276-00 in Subjects With Metastatic Triple Negative Breast Cancer, With a Phase I Run-in of Escalating Dose of P276-00 Added to Gemcitabine and Carboplatin


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

An Open-Label Randomized Phase II Trial Comparing Gemcitabine and Carboplatin With and Without P276-00 in Subjects With Metastatic Triple Negative Breast Cancer, With a Phase I Run-in of Escalating Dose of P276-00 Added to Gemcitabine and Carboplatin


Inclusion Criteria:



1. Females of age ≥18 years.

2. Histologically documented metastatic triple negative breast cancer (any triple
negative breast cancer for Phase I)

3. Two or fewer chemotherapy regimens for advanced disease (no limit of prior regimens
for Phase I)

4. ECOG performance score of 1 or less

5. Presence of measurable disease by RECIST 1.1 criteria (not for the Phase I portion)

6. Ability to understand and the willingness to sign a written informed consent document
(ICD)

7. Full recovery from all prior treatment toxicities to Common Terminology Criteria for
Adverse Events (CTCAE V.4) Grade ≤ 1

Exclusion Criteria:

1. Prior chemotherapy or biologic/targeted anticancer agents within 4 weeks of study
drug administration

2. Prior radiation therapy within 6 weeks of study drug administration

3. Subject with known active CNS metastases and/or carcinomatous meningitis. However,
subjects with CNS metastases who have completed a course of therapy would be eligible
for the study provided they are clinically stable for at least 1 month prior to entry
as defined as: (1) no evidence of new or enlarging CNS metastasis or new neurological
symptoms attributable to CNS metastases (2) off steroids that are used to minimize
surrounding brain edema.

4. Prior therapy with gemcitabine or a platinum agent (not for the Phase I part)

5. Prior therapy with a Cdk/cyclin inhibitor or any flavones derivative

6. QTc interval >450 msec (using Fridericia's formula)

7. Any acute illness including uncontrolled diabetes, symptomatic or otherwise
uncontrolled cardiac disease (coronary artery disease, arrhythmias, congestive heart
failure) or other illness that in the judgment of the investigator would introduce
additional medical risks

8. Visceral crisis including extensive liver disease with>50% parenchymal involvement or
lymphangitic pulmonary disease

9. History of other prior malignancies except for properly treated basal cell or
squamous cell carcinoma of skin, in situ cervical cancer, or in situ breast cancer

10. Expected survival of less than 3 months

11. Hemoglobin <9.0 gm/dL

12. Absolute neutrophil count <1500/mm3

13. Platelet count <100,000/mm3

14. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >3 ×
institutional upper limit of normal (ULN)

15. Total bilirubin, >1.5 × institutional ULN

16. Serum creatinine >1.5 mg/dL

17. Subjects with known infection with human immunodeficiency virus (HIV), tuberculosis,
Hepatitis C or Hepatitis B

18. Pregnant or lactating women

19. Women of childbearing potential not willing to use approved methods of contraception
after signing the ICD, during the entire study and for at least 4 weeks after
completion of study or following withdrawal from the study

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Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median Progression free survival

Outcome Description:

The primary efficacy endpoint will be median progression-free survival (PFS), defined as the time from the beginning of study treatment to the occurrence of documented disease progression or recurrence, or death from any cause

Outcome Time Frame:

1 year and above

Safety Issue:

No

Principal Investigator

Dr.Debasish Tripathy

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center 1441 Eastlake Avenue, Rm 3440, Los Angeles, CA 90033

Authority:

United States: Food and Drug Administration

Study ID:

P276-00/52/10

NCT ID:

NCT01333137

Start Date:

August 2011

Completion Date:

April 2013

Related Keywords:

  • Breast Cancer
  • Triple negative breast cancer
  • Breast Neoplasms

Name

Location

Washington UniversitySt. Louis, Missouri  63110
UC Davis Cancer CenterSacramento, California  95817
Disney Cancer CenterBurbank, California  
3855 Health Sciences DriveLa Jolla, California  92093