A Clinical Trial Comparing Gemcitabine and Carboplatin With and Without P276-00 in Subjects With Metastatic Triple Negative Breast Cancer, With a Run-in of Escalating Dose of P276-00 Added to Gemcitabine and Carboplatin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

P276-00 is a novel, potent, small-molecule, flavone-derived Cdk 4 D1, Cdk1 B, and Cdk9 T inhibitor, with potent cytotoxic effects against chemosensitive and chemoresistant cancer cell lines.This study is planned to compare efficacy of the standard chemotherapy regimen of gemcitabine and carboplatin when administered with or without P276-00 in subjects with advanced triple negative breast cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)

NCT02978716

Triple-Negative Breast Neoplasms Breast Neoplasm Breast Cancer +1 more

TERMINATED PHASE2

A Study of Pembrolizumab With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer

NCT02755272

Carcinoma Breast Stage IV

ACTIVE_NOT_RECRUITING PHASE2

Paclitaxel + Carboplatin + Durvalumab With or Without Oleclumab for Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC

NCT03616886

Triple Negative Breast Cancer

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer

NCT05112536

Triple Negative Breast Cancer Breast Cancer

COMPLETED PHASE2

Platinum and Polyadenosine 5'Diphosphoribose Polymerisation Inhibitor for Neoadjuvant Treatment of Triple Negative Breast Cancer and/or Germline BRCA Positive Breast Cancer

NCT03150576

Breast Cancer

RECRUITING PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gemcitabine and Carboplatin

Gemcitabine 1000 mg/m2/day on Days 1 \& 8 and carboplatin at AUC 2 on Days 1 and 8 every 21 days.

Group Type ACTIVE_COMPARATOR

Gemcitabine and Carboplatin

Intervention Type DRUG

Gemcitabine 1000 mg/m2/day on Days 1 \& 8 and carboplatin at AUC 2 on Days 1 and 8 every 21 days.

P276-00 along with Gemcitabine and carboplatin

P276-00 will be administered at starting dose of 100 mg/m2/day (and higher if tolerated) in 200 mL of 5% dextrose as an iv infusion over 30 minutes, on Days 1 to 5, along with gemcitabine 1000 mg/m2/day and carboplatin at AUC 2 on Days 1 \& 8 every 21 days.In Phase 2 component, P276-00 will be administered at recommended phase II dose of P276-00 in combination with standard dose of gemcitabine and carboplatin.

Group Type EXPERIMENTAL

P276-00 along with Gemcitabine and carboplatin

Intervention Type DRUG

In phase I run in period, P276 00 will be administered at starting dose of 100 mg/m2/day (and higher if tolerated) in 200 mL of 5% dextrose as an iv infusion over 30 minutes, on Days 1 to 5, along with gemcitabine 1000 mg/m2/day and carboplatin at AUC 2 on Days 1 \& 8 every 21 days. In Phase 2 component, P276-00 will be administered at recommended phase II dose of P276-00 in combination with standard dose of gemcitabine and carboplatin.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gemcitabine and Carboplatin

Gemcitabine 1000 mg/m2/day on Days 1 \& 8 and carboplatin at AUC 2 on Days 1 and 8 every 21 days.

Intervention Type DRUG

P276-00 along with Gemcitabine and carboplatin

In phase I run in period, P276 00 will be administered at starting dose of 100 mg/m2/day (and higher if tolerated) in 200 mL of 5% dextrose as an iv infusion over 30 minutes, on Days 1 to 5, along with gemcitabine 1000 mg/m2/day and carboplatin at AUC 2 on Days 1 \& 8 every 21 days. In Phase 2 component, P276-00 will be administered at recommended phase II dose of P276-00 in combination with standard dose of gemcitabine and carboplatin.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No