UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009498 |
|---|---|
| Receipt number | R000011159 |
| Scientific Title | A Phase I/II, open-label, non-randomized, multi-center, dose escalation study of olaparib in combination with eribulin mesylate to assess the safety, tolerability, and efficacy in patients with recurrent or metastatic triple-negative-type breast cancer, who have received anthracycline and taxane agents |
| Date of disclosure of the study information | 2012/12/10 |
| Last modified on | 2018/03/05 11:42:46 |
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Basic information
Public title
A Phase I/II, open-label, non-randomized, multi-center, dose escalation study of olaparib in combination with eribulin mesylate to assess the safety, tolerability, and efficacy in patients with recurrent or metastatic triple-negative-type breast cancer, who have received anthracycline and taxane agents
Acronym
A Phase I/II study of olaparib in combination with eribulin mesylate in patients with TNBC
Scientific Title
A Phase I/II, open-label, non-randomized, multi-center, dose escalation study of olaparib in combination with eribulin mesylate to assess the safety, tolerability, and efficacy in patients with recurrent or metastatic triple-negative-type breast cancer, who have received anthracycline and taxane agents
Scientific Title:Acronym
A Phase I/II study of olaparib in combination with eribulin mesylate in patients with TNBC
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The safety, tolerability, and MTD of olaparib in combination with eribulin mesylate will be assessed, based on the incidence of dose limiting toxicity at each dose level in Phase I. The efficacy and safety of the combination will be assessed, in Phase II.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I: Safety and tolerability
Phase II: Response rates
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eribulin mesylate administer day 1, day 8, tri-weekly interval. Olaparib administer continuously and/or intermittently according to in each cohort. The trial treatment will be continued until there is progressive disease.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1)Histological confirmation of invasive breast cancer
2)Unresectable clinical StageIIIB, IIIC or IV or eligible for systemic chemotherapy for recurrent breast cancer
3)Histological confirmation of breast cancer without overexpression of HER2 (0 or 1+ in immunohistocompatibility (IHC), or negative in in-situ hybridization (ISH) tests).
4)Histological confirmation of hormonal receptor-negative breast cancer (Allred score < 3 in the IHC test for estrogen receptor and progesterone receptor).
5)PS (ECOG) 0 to 1
6)A treatment history of anthracycline and taxane agents, irrespective of the type of combination or treatment order
7)Patients with the following values in their latest laboratory tests
-Neutrophil count > 1,500/mm3
-Hemoglobin > 9.0/dL
-Platelet count > 100,000/mm3
-Total bilirubin < 1.5 mg/dL
-Serum AST/ALT < 100 IU/L
-Serum creatinine < 1.2 mg/dL
-ECG Normal or minimal changes not requiring treatment and QTc interval < 450 ms
8)Recovery to grade 0 or 1 from all toxicities related to chemotherapy and radiotherapy, except for stable grade 0 to 2 sensory neuropathy and alopecia
Key exclusion criteria
1)Pregnant or breast-feeding women, or women of child bearing potential who intend to become pregnant
2)Patients who received treatment (chemotherapy or study treatment) within 1 week from the last administration or underwent treatment procedures (surgery or exposure to radiation) within the 2 weeks preceding enrollment
3)Patients with respiratory failure requiring oxygen inhalation therapy
4)Patients requiring therapeutic dosages of warfarin or related agents
5)Patients with signs or symptoms of interstitial pneumonia or pulmonary fibrosis
6)Patients who are HBs antigen-positive, HCV antibody-positive and/or HIV antibody-positive (Patients who are HBV-DNA positive and/or HCV-RNA positive are cannot be allowed)
7)Patients with serious cardiovascular disease
8)Patients with diabetes mellitus associated with poor glycemic control or receiving insulin
9)Patients with metastases to brain
10)Patients with meningeal carcinomatosis
11)Patients with gastrointestinal obstruction or the symptoms of it
12)Patients with synchronous double cancer, not including lesions equivalent to carcinoma in situ or mucosal carcinoma considered healed with topical therapy
13)Patients who have no features suggestive of MDS/AML on peripheral blood smear
14)Patients receiving the following classes of CYP3A4 inhibitors and inducers
-CYP3A4 inhibitors: Azole antifungals, Macrolide antibiotics, Protease inhibitors
-CYP3A4 inducers: Phenytoin, Rifampicin, Carbamazepine, Barbiturate derivatives
15)Patients with history of treatment with or allergy to eribulin mesylate
Patients with history of treatment with or allergy to PARP inhibitors
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kan Yonemori |
Organization
National Cancer Center Hospital
Division name
Breast and Medical Oncology Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo104-0045, Japan
TEL
03-3542-2511
Olaparib_trial_office@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tamie Sukigara |
Organization
National Cancer Center
Division name
Clinical Trial Support Office
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo104-0045, Japan
TEL
03-3547-5201
Homepage URL
Olaparib_trial_office@umin.ac.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Medical Association
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
独立行政法人国立病院機構大阪医療センター（大阪府）
独立行政法人国立病院機構四国がんセンター（愛媛県）
独立行政法人国立病院機構北海道がんセンター（北海道）
地方独立行政法人神奈川県立病院機構神奈川県立がんセンター（神奈川県）
千葉県がんセンター（千葉県）
独立行政法人国立がん研究センター中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 06 | Day |
Last modified on
| 2018 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011159
