Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer

NCT03326102 | Completed Phase 2 FDA Drug

• 1 other identifier: 107CS-6
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 15

Brief Summary

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of DHP107 (Oral Paclitaxel, Korea brand name: Liporaxel®) compared to IV Paclitaxel in patients with Recurrent or Metastatic Breast Cancer.

Conditions

Recurrent or Metastatic Breast Cancer

Keywords

Breast Cancer; DHP107; Paclitaxel; Liporaxel

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

  ORR is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria

  Every 8 weeks upto 18 months from randomization date

Secondary Outcomes (7)

• Progression free survival(PFS)

  Up to 18 months from randomization date

• Overall survival(OS)

  Up to 36 months from FPI

• Time to treatment failure(TTF)

  Up to 18 months from randomization date

• Duration of response(DOR)

  Up to 18 months from randomization date

• Disease control rate(DCR)

  Up to 18 months from randomization date

Study Arms (2)

DHP107

EXPERIMENTAL

The 12 eligible subjects will receive DHP107 and be taken blood samples for PK analysis on Day 1, 8 of cycle 1. Total 48 subjects (including PK subjects) will receive DHP107 200 mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days.

Drug: DHP107

IV paclitaxel

EXPERIMENTAL

Total 24 subject will receive IV paclitaxel 80 mg/m2 weekly.(3 weeks on/1 week off)

Drug: IV Paclitaxel

Interventions

DHP107 DRUG

DHP107 200mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days

Also known as: Liporaxel®, Oral Paclitaxel

DHP107

IV Paclitaxel DRUG

IV Paclitaxel 80 mg/m2 QW (3 weeks on/1 week off)

Also known as: Taxol Injection

IV paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with confirmed diagnosis of recurrent or metastatic breast cancer based on histopathology examination
• Subjects with diagnosis of HER2-negative breast cancer that was confirmed by IHC or in situ hybridization (ISH) assessment of tumor samples
• Subjects who have received up to 3 lines of therapy for advanced disease, without prior exposure to taxane in the advanced stage setting
• Subjects who have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.
• Subjects who have measurable disease according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1).

You may not qualify if:

• Subjects who have received prior taxane therapy in the metastatic setting
• Subjects whose adjuvant or neoadjuvant treatment for early stage breast cancer was completed within 6 months prior to entry into the study.
• Subjects with neuropathy grade ≥2 based on CTCAE v4.03 at the time of study entry
• Subjects with symptomatic, untreated metastases to the central nervous system (CNS) at the time of screening.
• Subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (C1D1).

Sponsors & Collaborators

• Daehwa Pharmaceutical Co., Ltd.: lead

Study Sites (15)

California Research Institute (CRI)

Los Angeles, California, 90027, United States

Location

University of California San Francisco (UCSF)

San Francisco, California, 94115, United States

Location

Boca Raton Regional Hospital (BRRH)

Boca Raton, Florida, 33486, United States

Location

ASCLEPES Research Center(ARC)

Weeki Wachee, Florida, 34607, United States

Location

Saint Luke's Cancer Institute(SLCI)

Kansas City, Kansas, 64111, United States

Location

University of Kansas Medical Center(KUMC)

Kansas City, Kansas, 66160, United States

Location

Anne Arundel Health System Research Institute (AAHS)

Annapolis, Maryland, 21401, United States

Location

Massachusetts General Hospital(MGH)

Boston, Massachusetts, 02114, United States

Location

Michigan Center of Medical Research(MCMR)

Farmington Hills, Michigan, 48334, United States

Location

Metro-Minnesota Community Oncology Research Consortium (MMCORC)

Minneapolis, Minnesota, 55426, United States

Location

Nevada Cancer Research Foundation (NCRF)

Las Vegas, Nevada, 89106, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15232, United States

Location

Onkologicka klinika, Fakultni nemocnice Olomouc (OUH)

Olomouc, I.P. Pavlova 6, 775 20, Czechia

Location

Onkologicky stacionar, NH Hospital a.s., nemocnice Horovice (NHH)

Hořovice, K Nemocnici, 1106268 31, Czechia

Location

Onkologicka klinika, Vseobecna fakultni nemocnice v Praze (VFN)

Prague, U Nemocnice 499/2, 128 08, Czechia

Location

MeSH Terms

Conditions

Recurrence; Breast Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Hope Rugo, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• David Weng, M.D.

  Anne Arundel Health System Research Institute (AAHS)

  PRINCIPAL INVESTIGATOR

• Neelima Vidula, M.D.

  Massachusetts General Hospital (MGH)

  PRINCIPAL INVESTIGATOR

• Adam Brufsky, M.D.

  University of Pittsburgh Medical Center (UPMC)

  PRINCIPAL INVESTIGATOR

• Timothy Pluard, M.D.

  Saint Luke's Cancer Institute(SLCI)

  PRINCIPAL INVESTIGATOR

• Priyanka Sharma, M.D.

  University of Kansas Medical Center(KUMC)

  PRINCIPAL INVESTIGATOR

• Jane Skelton, M.D.

  Boca Raton Regional Hospital (BRRH)

  PRINCIPAL INVESTIGATOR

• Richard Caradonna, M.D.

  ASCLEPES Research Center(ARC)

  PRINCIPAL INVESTIGATOR

• Yan Ji, M.D.

  Metro-Minnesota Community Oncology Research Consortium (MMCORC)

  PRINCIPAL INVESTIGATOR

• Craig Gordon, D.O.

  Michigan Center of Medical Research(MCMR)

  PRINCIPAL INVESTIGATOR

• Ghassan Aljazayrly, M.D.

  California Research Institute (CRI)

  PRINCIPAL INVESTIGATOR

• John Ellerton, M.D.

  Nevada Cancer Research Foundation (NCRF)

  PRINCIPAL INVESTIGATOR

• Bohuslav Melichar, M.D.

  Onkologicka klinika, Fakultni nemocnice Olomouc (OUH)

  PRINCIPAL INVESTIGATOR

• Martin Smakal, M.D.

  Onkologicky stacionar, NH Hospital a.s., nemocnice Horovice (NHH)

  PRINCIPAL INVESTIGATOR

• Martina Zimovjanova, M.D.

  Onkologicka klinika, Vseobecna fakultni nemocnice v Praze (VFN)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be assigned to DHP107 or IV paclitaxel in a ratio of 2:1 (n=48 to DHP107 and n=24 to IV paclitaxel)

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 30, 2017
• Study Start: July 6, 2018
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: February 16, 2024

Record last verified: 2022-01

Locations

CZ (3); US (12)