Clinical Study of Decitabine and Paclitaxel Combination Therapy

Advanced Breast Cancer Clinical Trial

Official title:

An Open-labelled, Parallel, Multiple Ascending Dose, Phase Ib Clinical Study of Decitabine and Paclitaxel Combination Therapy in Treating Patients With Metastatic and Locally Advanced Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03282825
• Other study ID #: DW1018-I-1
• Status: Active, not recruiting
• Phase: Phase 1
• First received: September 8, 2017
• Last updated: January 21, 2018
• Start date: March 28, 2017
• Est. completion date: May 2018

Study information

• Verified date: January 2018
• Source: Dong Wha Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase Ib clinical study of Decitabine and Paclitaxel combination therapy

Description:

An open-labelled, parallel, multiple ascending dose, phase Ib clinical study of Decitabine and Paclitaxel combination therapy in treating patients with metastatic and locally advanced breast cancer

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: May 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. age = 19 years as female

2. be unable to operate for therapy with HER2 negative breast adenocarcinoma and metastatic breast cancer, one or more chemotherapy

3. according to RECIST ver.1.1, one or more evaluable lesion

4. Eastern cooperative oncology group(ECOG) performance score is o or 1

5. lesion for core biopsy

6. Within 28days of planned first study treatment day, laboratory safety test is satisfied. ANC =1500cells/microliter, Platelet count = 100,000 cells/microliter, Hemoglobin=8.5g/dl, ALT and AST = 2ULN, ALP=2.5ULN, Serum total bilirubin=1.25 ULN, PT-INR and aPTT=1.5ULN, Creatinine=50ml/min

7. menopause or informed that effective contraception must be used during the entire treatment period of this study and for 6 months after exiting from the study

8. Given signed and dated written informed consent form

Exclusion Criteria:

1. Symptomatic metastasis and Leptomeningeal metastasis

2. Injection of paclitaxel for metastatic breast cancer within 6 months

3. HER2, Positive Breast adenocarcinoma

4. cancertherapy for whole body within 3 weeks

5. radiotherapy for metastatic region within 4 weeks

6. major surgery, open biopsy and trauma within 4 weeks

7. less than 4 weeks post major surgery

8. treatment with consistently systemic corticosteroid or immunosuppressive drug

9. more than 2 grade for peripheral neuropathy

10. Congenital ling QT syndrome or QTc interval > 480 milisecond

11. occur myocardial infartion within 6 months

12. unstable angina pectoris

13. HIV(+) or AIDS

14. HBsAg(+) or HCV(+)

15. treatment bisphosphonate for hypercalcemia

16. except metastatic and locally advanced breast cancer, personal history with malignancy within 5 years

17. hypersensitivity reaction with paclitaxel or Cremophor EL formulation

18. Pregnant or breast feeding

19. be unable or unwilling to abide by the study protocol or to cooperate fully with the investigator or designee

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Decitabine
The subjects will be sequential administered with Decitabine and paclitaxel 80mg/m2 by IV(intravenous) infusion. Decitabine is starting dose of 15mg/m2 on 1D, 8D, 22D, 28D of a 28day cycle. Paclitaxel 80mg/m2 will be dosed in combination therapy with Decitabine on 8D, 22D, 28D of a 28day cycle.
• Paclitaxel
The subjects will be sequential administered with Decitabine and paclitaxel 80mg/m2 by IV(intravenous) infusion. Decitabine is starting dose of 15mg/m2 on 1D, 8D, 22D, 28D of a 28day cycle. Paclitaxel 80mg/m2 will be dosed in combination therapy with Decitabine on 8D, 22D, 28D of a 28day cycle.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong Wha Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerant Dose (MTD) and Dose Limiting Toxicity (DLT)	According to principle of Dose Limited Toxicity (DLT) assessment by National Cancer Institute Common Terminonlgy Criteria for Adverse Events (NCI-CTCAE, V4.0), DLT is evaluated above grade 3 as adverse event.	for about 4 weeks