Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer (OPERA)

• ClinicalTrials.gov Identifier: NCT03326102
• Recruitment Status: Recruiting
• First Posted: October 30, 2017
• Last Update Posted: March 13, 2020
• Sponsor: Daehwa Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Daehwa Pharmaceutical Co., Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Recurrent or Metastatic Breast Cancer	Drug: DHP107; Drug: IV Paclitaxel	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-center, Open-label, Phase 2 Clinical Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of DHP107 (Liporaxel®, Oral Paclitaxel) Compared to IV Paclitaxel in Patients With Recurrent or Metastatic Breast Cancer(OPERA)
• Actual Study Start Date: July 25, 2018
• Estimated Primary Completion Date: September 2020
• Estimated Study Completion Date: April 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: DHP107; 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; DHP107 200mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days; Other Name: Liporaxel®, Oral Paclitaxel
Experimental: IV paclitaxel; Total 24 subject will receive IV paclitaxel 80 mg/m2 weekly.(3 weeks on/1 week off)	Drug: IV Paclitaxel; IV Paclitaxel 80 mg/m2 QW (3 weeks on/1 week off); Other Name: Taxol Injection

Outcome Measures

Primary Outcome Measures :

1. Objective Response Rate(ORR) [ Time Frame: Every 8 weeks upto 18 months from randomization date ]
   ORR is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria

Secondary Outcome Measures :

1. Progression free survival(PFS) [ Time Frame: Up to 18 months from randomization date ]
   PFS is defined as the time from date of randomization until the date of first documented progression or death.
2. Overall survival(OS) [ Time Frame: Up to 36 months from FPI ]
   OS is defined as the time from the date of inclusion to the date of death.
3. Time to treatment failure(TTF) [ Time Frame: Up to 18 months from randomization date ]
   TTF is defined as the time from the randomization date to the date of discontinuation of treatment, regardless of the cause.
4. Duration of response(DOR) [ Time Frame: Up to 18 months from randomization date ]
   DOR is the time between the initial response to therapy and subsequent disease progression or relapse.
5. Disease control rate(DCR) [ Time Frame: Up to 18 months from randomization date ]
   DCR is defined as the percentage of subjects who were evaluated for complete response(CR), partial response(PR), and stable disease(SD) as the best response among from randomization.
6. Quality of life(QoL) [ Time Frame: after randomization(C1D1), D1 of every 3rd cycle(each cycle consists of 28 days) up to 18 months ]
   Evaluate changes compared to baseline using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
7. AUC [ Time Frame: on Day 1 of Cycle 1(each cycle consists of 28days) at predose, 1, 2, 3, 4, 6 and 10 hrs post dose (before the 2nd dose on Day 1) and on Day 8 of Cycle 1 at predose (before the 1st dose on Day 8) ]
   Area under the plasma concentration-time curve
8. Cmax [ Time Frame: on Day 1 of Cycle 1(each cycle consists of 28days) at predose, 1, 2, 3, 4, 6 and 10 hrs post dose (before the 2nd dose on Day 1) and on Day 8 of Cycle 1 at predose (before the 1st dose on Day 8) ]
   Maximum concentration
9. Tmax [ Time Frame: on Day 1 of Cycle 1(each cycle consists of 28days) at predose, 1, 2, 3, 4, 6 and 10 hrs post dose (before the 2nd dose on Day 1) and on Day 8 of Cycle 1 at predose (before the 1st dose on Day 8) ]
   Time to reach observed maximum concentration

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Hope Rugo, M.D.; 415-353-7070; Hope.Rugo@ucsf.edu

Locations

United States, California

California Research Institute (CRI); Recruiting

Los Angeles, California, United States, 90027

Contact: Ghassan Aljazayrly, M.D.

University of California San Francisco (UCSF); Recruiting

San Francisco, California, United States, 94115

Contact: Rugo Hope, M.D. 415-353-7070 Hope.Rugo@ucsf.edu

Contact: Michelle Melisko, M.D.

United States, Florida

Boca Raton Regional Hospital (BRRH); Terminated

Boca Raton, Florida, United States, 33486

ASCLEPES Research Center(ARC); Recruiting

Weeki Wachee, Florida, United States, 34607

Contact: Richard Caradonna, M.D.

United States, Kansas

Saint Luke's Cancer Institute(SLCI); Recruiting

Kansas City, Kansas, United States, 64111

Contact: Timothy Pluard, M.D.

University of Kansas Medical Center(KUMC); Recruiting

Kansas City, Kansas, United States, 66160

Contact: Priyanka Sharma, M.D.

United States, Maryland

Anne Arundel Health System Research Institute (AAHS); Terminated

Annapolis, Maryland, United States, 21401

United States, Massachusetts

Massachusetts General Hospital(MGH); Recruiting

Boston, Massachusetts, United States, 02114

Contact: Vidula Neelima, M.D. 617-724-4000

United States, Michigan

Michigan Center of Medical Research(MCMR); Recruiting

Farmington Hills, Michigan, United States, 48334

Contact: Craig Gordon, D.O.

United States, Minnesota

Metro-Minnesota Community Oncology Research Consortium (MMCORC); Recruiting

Minneapolis, Minnesota, United States, 55426

Contact: Yan Ji, M.D.

United States, Nevada

Nevada Cancer Research Foundation (NCRF); Recruiting

Las Vegas, Nevada, United States, 89106

Contact: John Ellerton, M.D.

United States, Pennsylvania

University of Pittsburgh Medical Center (UPMC); Terminated

Pittsburgh, Pennsylvania, United States, 15232

Sponsors and Collaborators

Daehwa Pharmaceutical Co., Ltd.

Investigators

• Principal Investigator: 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)

More Information

• Responsible Party: Daehwa Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03326102
• Other Study ID Numbers: 107CS-6
• First Posted: October 30, 2017
• Last Update Posted: March 13, 2020
• Last Verified: March 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daehwa Pharmaceutical Co., Ltd.:

Breast Cancer; DHP107; Paclitaxel; Liporaxel

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Paclitaxel; Albumin-Bound Paclitaxel; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action