A clinical trial to determine the most suitable dose of OPB-111001 in patients with advanced cancer
- Conditions
- • Advanced prostate cancer• Advanced epithelial ovarian cancer, advanced squamous cell carcinoma of the cervix, advanced breast cancer, endometrial cancer, and salivary gland cancer that are poorly responsive to standard treatment optionsMedDRA version: 16.0Level: PTClassification code 10061934Term: Salivary gland cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: PTClassification code 10014733Term: Endometrial cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: PTClassification code 10041848Term: Squamous cell carcinoma of the cervixSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-001249-15-GB
- Lead Sponsor
- Otsuka Novel Products GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
The patient should meet the following inclusion criteria to be considered for enrollment into the study
1. Patients =18 years of age at Screening
2. Patients with prostate cancer that is recurrent or did not respond to previous
hormone therapy and/or who have exhausted standard treatment options.
For the dose escalation parts only: Patients with any of the following diseases
who have exhausted standard treatment options:
a.recurrent or refractory ovarian cancer
b.recurrent or refractory cervical squamous cell carcinoma
c.recurrent or refractory breast cancer
d.recurrent or refractory salivary gland cancer
e.recurrent or refractory endometrial cancer
3. Histologically or cytologically documented diagnosis of cancer
4. Measurable disease according to Response Evaluation Criteria in Solid Tumours
(RECIST), Version 1.1 or
a.for prostate cancer also evaluable disease (nonmeasurable) defined as
prostate-specific antigen progression according to Prostate Cancer Working
Group 2 eligibility criteria
b.for ovarian cancer also evaluable disease (nonmeasurable) according to the
Gynaecologic Cancer Intergroup
5. Absolute neutrophil count =1.5 (1500/mm3) and platelets =100 × 10E9/L (without
platelet transfusion within the last 4 weeks before first study drug
administration), and haemoglobin =9 g/dL at Screening
6. Alanine aminotransferase and aspartate aminotransferase =2.5 × the upper limit
of normal (ULN), Total bilirubin =1.5 × ULN (exception: patients with liver
metastasis are allowed to have aspartate aminotransferase =5 × ULN and alanine
aminotransferase =5 × ULN) at screening
7. Albumin =26 g/L at Screening
8. Estimated life expectancy >3 months (as judged by investigator)
9. Eastern Cooperative Oncology Group performance status =1
10. In prostate cancer patients: ongoing therapy with luteinizing hormone
releasing hormone analogue or orchiectomy
11. Agreement of female patients of childbearing potential and male patients who
have partners capable of reproduction to use an effective double-barrier
contraceptive method during the course of the study and for 3 months following
the completion of their last treatment. Females of childbearing potential must
have a negative beta-human chorionic gonadotropin pregnancy test result within
3 days of the first study drug administration. Female patients who are
surgically sterilized or who are >45 years old and have not experienced menses
for >2 years may have the beta-human chorionic gonadotropin pregnancy test
waived.
12. Ability to understand and give written informed consent and to comply with the
protocol (i.e., with all study-related procedures, medication use, and
evaluations)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1. Concurrent prior treatment-related toxicity of Grade 2 or higher.
Exception: any toxicity that is in the view of the investigator not a clinically
significant safety risk for IMP administration.
2. Previous treatment with cytotoxic chemotherapy or other anticancer therapy
within 4 weeks before the first dosing with study drug (at least 6 weeks for
mitoxantrone, nitrosurea, and bicalutamide).
3. Treatment with systemic glucocorticosteroids of more than a 2 mg dexamethasone
equivalent (e.g., 13 mg prednisolone) per day or in cases of treatment with =2
mg dexamethasone equivalent per day:
a.Dosing was changed within 6 weeks before Screening
or
b.The patient’s cancer is responding to glucocorticosteroid intake(as by
investigator judgment)
4. Radiation therapy within 4 weeks prior to the first dosing with IMP.
5. Treatment with a systemic IMP in a clinical trial within 28 days before the
Screening visit.
6. Use of prohibited medications within 21 days of the first dose of IMP.
7. Current or past history of clinically significant gastrointestinal disease or
major gastrointestinal surgery, malabsorption syndrome, or other conditions that
could interfere with enteral absorption.
8. Significant uncontrolled cardiovascular disease or cardiac insufficiency (New
York Heart Association classes III to IV) or a history of ventricular arrhythmia
requiring medication.
9. Patients with symptomatic central nervous system metastasis.
10. History of positive human immunodeficiency virus test result (enzyme-linked
immunosorbent assay or Western blot)
11. Clinical or laboratory evidence of active or chronic hepatitis B or hepatitis C
infection.
12. Major surgery =4 weeks before the first study drug administration or ongoing
side effects of previous major surgery.
13. Concurrent clinically significant unrelated systemic illness (e.g., serious
infection) or significant pulmonary, hepatic, or other organ dysfunction that
would compromise the patient’s ability to tolerate study treatment or would
likely interfere with study procedures or results.
14. Active treatment/chemotherapy for another primary malignancy within the past 3
years (except for nonmelanoma skin cancer and cervical carcinoma in situ).
15. Women who are pregnant or breastfeeding.
16. Known or suspected hypersensitivity to the excipients (ingredients) in the
study drug formulation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The principal objective of this clinical study is to find out how well the patients can tolerate OPB-111001 and to find the maximum tolerated dose in patients with cancer of the prostate, ovary, cervix, endometrium, breast, or salivary gland;Secondary Objective: The secondary objective is to look at how the drug responds in the body when administrated to a patient and its initial effect on the type of cancer.<br><br><br>;Primary end point(s): The primary outcome measures are the determine the safety and tolerability of OPB111001 in order to establish an MTD and recommended phase II dose. This will be achieved by monitoring the incidence of AEs (defined by NCI CTCAE V4), along with vital signs, clinical laboratory parameters and electrocardiography assessments.;Timepoint(s) of evaluation of this end point: 1) MTD/RP2D - Dose Escalation Part: After 1 or 3 cycles of treatment, Tolerability:<br> Continuously
- Secondary Outcome Measures
Name Time Method