Clinical Trials List
Protocol Number317-KOA-1401i
NCT Number(ClinicalTrials.gov Identfier)NCT02250170
2016-09-19 - 2018-04-30
Phase I
Terminated4
ICD-10C80.1
Malignant (primary) neoplasm, unspecified
A Phase 1, Open-label, Non-Randomized, Dose Escalation Trial to Evaluate Safety and Biomarker of OPB-111077 in Subjects with Advanced Solid Tumor
-
Trial Applicant
COVANCE TAIWAN SERVICES LIMITED
-
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Principal Investigator
Co-Principal Investigator
- Su-Peng Yeh 未分科
Audit
None
Co-Principal Investigator
- Chih-Hung Hsu 無
- Kun-Huei Yeh 無
- Chiun Hsu 無
- 張端瑩 無
- Yeong-Shiau Pu 無
- 林璟宏 無
- YEN-SHEN LU 無
- - - 無
- Jih-Hsiang Lee 無
- Yu-Chieh Tsai 無
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Advanced Solid Tumor
Objectives
[Primary]
1) Dose Escalation Part
To determine the safety, tolerability, maximum tolerated
dose (MTD) and recommended dose (RD) of OPB111077 administered orally 4 consecutive days on and 3
consecutive days off in a week for 3 weeks (21 days) to
subjects with advanced solid tumor
2) Expansion Part
To evaluate the biomarker (BM) related to OPB-111077
when administered at RD to subjects with selected tumor
types
[Secondary]
1) Dose Escalation Part
To evaluate the BM related to OPB-111077
To investigate the antitumor activity of OPB-111077 as
assessed using Response Evaluation Criteria in Solid
Tumors (RECIST 1.1)
To investigate the pharmacokinetic (PK) properties of
OPB-111077 free base and its metabolites
2) Expansion Part
To determine the safety of OPB-111077 when
administered at RD
To investigate the antitumor activity of OPB-111077 as
assessed using Response Evaluation Criteria in Solid
Tumors (RECIST 1.1)
To investigate the PK properties of OPB-111077 free base
and its metabolites
Test Drug
OPB-111077 100-mg Tablets
Active Ingredient
OPB-111077
Dosage Form
tablet
Dosage
100
Endpoints
1) Safety
AEs*
, Clinical laboratory tests, Vital signs, 12-lead
electrocardiogram (ECG), Body weight
* To evaluate with CTCAE version 4.0.
2) Biomarker
Relationship between efficacy and patient selection markers in
tumor tissue and peripheral blood (Predictive biomarker),
Changes in pharmacodynamic markers (PD marker) before and
after administration of OPB-111077 in tumor tissue and
peripheral blood
3) Efficacy
Overall response rate (ORR), Disease control rate (DCR) and
Time to progression (TTP) as assessed by RECIST 1.1
4) Pharmacokinetics
Changes in plasma drug and metabolites concentrations of OPB111077 and pharmacokinetic parameters
AEs*
, Clinical laboratory tests, Vital signs, 12-lead
electrocardiogram (ECG), Body weight
* To evaluate with CTCAE version 4.0.
2) Biomarker
Relationship between efficacy and patient selection markers in
tumor tissue and peripheral blood (Predictive biomarker),
Changes in pharmacodynamic markers (PD marker) before and
after administration of OPB-111077 in tumor tissue and
peripheral blood
3) Efficacy
Overall response rate (ORR), Disease control rate (DCR) and
Time to progression (TTP) as assessed by RECIST 1.1
4) Pharmacokinetics
Changes in plasma drug and metabolites concentrations of OPB111077 and pharmacokinetic parameters
Inclution Criteria
Patients who meet the following inclusion criteria will be
selected.
1) Pathologically and/or cytologically confirmed advanced
solid tumor
2) Patients who were refractory to standard therapy or for
which there are no standard treatment options available
3) Patients with measurable of evaluable lesions using
RECIST v 1.1
4) Patients must provide archived primary tumor tissue
samples at least 12 slides. Also, if patients have at least one
tumor lesion that is suitable for repeat biopsy and agree to
paired tumor biopsies (pre- and post- treatment), fresh
biopsy tumor tissue samples should be collected preferably
12 slides (at least 3 slides)*
. * For dose escalation part, at least one patient need to provide paired fresh
biopsy tumor tissue samples in each cohort.
And for expansion part, at least three patients need to provide paired
fresh biopsy tumor tissue samples in each tumor type.
5) Age 20 to 80 years at the time of informed consent
6) Patients with Eastern Cooperative Oncology Group
(ECOG) performance status score of 0 or 1
7) Patients with life expectancy of at least 3 months at the time
of informed consent.
8) Patients with adequate vital organ function at screening
examination as follows.
Hemoglobin ≥ 9.0 g/dL
Platelet counts ≥ 75,000/mm3
Mature neutrophil count (ANC) ≥ 1,500/mm3
Aspartate aminotransferase (AST) and Alanine
aminotransferase (ALT) ≤ 3.0 × ULN
In the presence of known liver metastasis, AST and ALT
≤ 5 × ULN
Total bilirubin ≤ 1.5 × ULN
Serum creatinine ≤ 1.5 × ULN
9) Patients who, together with their partner, are willing and
capable of using an appropriate method of contraception
throughout the trial period and until at least 12 weeks after
final IMP administration
10) Patients informed of the diagnosis of advanced solid tumor
who are fully informed about the content of the study by
the investigator or subinvestigator using the specified
written consent form and other written explanation, and
give written consent to participate in the study of their free
will
11) Patients who are able to take oral medication
selected.
1) Pathologically and/or cytologically confirmed advanced
solid tumor
2) Patients who were refractory to standard therapy or for
which there are no standard treatment options available
3) Patients with measurable of evaluable lesions using
RECIST v 1.1
4) Patients must provide archived primary tumor tissue
samples at least 12 slides. Also, if patients have at least one
tumor lesion that is suitable for repeat biopsy and agree to
paired tumor biopsies (pre- and post- treatment), fresh
biopsy tumor tissue samples should be collected preferably
12 slides (at least 3 slides)*
. * For dose escalation part, at least one patient need to provide paired fresh
biopsy tumor tissue samples in each cohort.
And for expansion part, at least three patients need to provide paired
fresh biopsy tumor tissue samples in each tumor type.
5) Age 20 to 80 years at the time of informed consent
6) Patients with Eastern Cooperative Oncology Group
(ECOG) performance status score of 0 or 1
7) Patients with life expectancy of at least 3 months at the time
of informed consent.
8) Patients with adequate vital organ function at screening
examination as follows.
Hemoglobin ≥ 9.0 g/dL
Platelet counts ≥ 75,000/mm3
Mature neutrophil count (ANC) ≥ 1,500/mm3
Aspartate aminotransferase (AST) and Alanine
aminotransferase (ALT) ≤ 3.0 × ULN
In the presence of known liver metastasis, AST and ALT
≤ 5 × ULN
Total bilirubin ≤ 1.5 × ULN
Serum creatinine ≤ 1.5 × ULN
9) Patients who, together with their partner, are willing and
capable of using an appropriate method of contraception
throughout the trial period and until at least 12 weeks after
final IMP administration
10) Patients informed of the diagnosis of advanced solid tumor
who are fully informed about the content of the study by
the investigator or subinvestigator using the specified
written consent form and other written explanation, and
give written consent to participate in the study of their free
will
11) Patients who are able to take oral medication
Exclusion Criteria
Patients who fall under any of the following criteria at the time of
enrollment will be excluded.
1) Patients with symptomatic brain metastases*1. *1 If patients have symptoms which brain metastasis is suspected, an
appropriate test of identifying the presence of brain metastasis should
be performed.
2) Patients with CTCAE Grade 1 or higher pneumonitis
(interstitial pneumonia) or pulmonary fibrosis*2
*2 If interstitial lung abnormalities (eg, ground-glass or linear opacity) are
suspected on chest CT scan (high-resolution CT), regardless of whether
or not there are any accompanying symptoms, it must be confirmed,
such as through consultation with a respiratory or radiology expert if
necessary, that the patient does not fall under this exclusion criterion
before the patient can be enrolled in the trial.
3) Patients with active double cancer (concurrent cancer or
metachronous double cancer with disease-free interval of
less than 5 years), except for following conditions
Carcinoma in situ of the cervix or basal cell carcinoma of
the skin
Gastric cancer and colorectal cancer with curative
resection by endoscopic therapy
4) Patients with pathologically and/or cytologically confirmed
pancreatic cancer
5) Patients with peripheral neuropathy (Grade 2 or higher of
NCI-CTCAE ver. 4.0)
6) Patients who have not recovered from any prior therapy
related toxicity deemed to be clinically significant at study
entry, except for the test item defined in inclusion criteria 8.
7) Patients with active infections needing whole body therapy
8) Patients with positive hepatitis B surface (HBs) antigen or
positive hepatitis C virus (HCV) antibody
9) Patients with positive human immunodeficiency virus
(HIV) antibody
10) Patients with uncontrollable cardiac diseases [New York
Heart Association (NYHA) Functional Classification Class
III or IV] or uncontrollable diabetes (including skin
ulceration) or uncontrollable hypertension
11) Patients with uncontrollable pain by analgesic drugs
12) Patients with a history of organ transplantation
13) Patients with hypothyroidism requiring treatment
14) Patients who have received another IMP,
immunosuppressant, bisphosphonate*3, or who have
received chemotherapy, hormone therapy, cytokine therapy,
surgery, radiotherapy, or photodynamic therapy for
treatment of the primary disease, or blood and/or albumin
transfusion within 4 weeks prior to the start of IMP
administration *3 If bisphosphonate has been used before 4 weeks prior to the start of
IMP administration, this drug may be used continuously if there is no
increase of the dose from 4 weeks prior to the start of IMP
administration to the final examination day of the final cycle.
15) Patients who have continuously received systemic
administration of corticosteroids, biguanide oral
antihyperglycemic drugs (such as metformin), drugs which
are cytochrome P450 (CYP) 3A4 inhibitors or inducers, or
foods and drinks which are possible cytochrome P450
(CYP) 3A4 inhibitors or inducers within 1 week prior to the
start of IMP administration
16) Patients with psychiatric diseases limiting the compliance
of clinical trial
17) Patients who are pregnant, possibly pregnant, or lactating
18) Patients otherwise judged by the investigator or
subinvestigator to be inappropriate for inclusion in the trial
enrollment will be excluded.
1) Patients with symptomatic brain metastases*1. *1 If patients have symptoms which brain metastasis is suspected, an
appropriate test of identifying the presence of brain metastasis should
be performed.
2) Patients with CTCAE Grade 1 or higher pneumonitis
(interstitial pneumonia) or pulmonary fibrosis*2
*2 If interstitial lung abnormalities (eg, ground-glass or linear opacity) are
suspected on chest CT scan (high-resolution CT), regardless of whether
or not there are any accompanying symptoms, it must be confirmed,
such as through consultation with a respiratory or radiology expert if
necessary, that the patient does not fall under this exclusion criterion
before the patient can be enrolled in the trial.
3) Patients with active double cancer (concurrent cancer or
metachronous double cancer with disease-free interval of
less than 5 years), except for following conditions
Carcinoma in situ of the cervix or basal cell carcinoma of
the skin
Gastric cancer and colorectal cancer with curative
resection by endoscopic therapy
4) Patients with pathologically and/or cytologically confirmed
pancreatic cancer
5) Patients with peripheral neuropathy (Grade 2 or higher of
NCI-CTCAE ver. 4.0)
6) Patients who have not recovered from any prior therapy
related toxicity deemed to be clinically significant at study
entry, except for the test item defined in inclusion criteria 8.
7) Patients with active infections needing whole body therapy
8) Patients with positive hepatitis B surface (HBs) antigen or
positive hepatitis C virus (HCV) antibody
9) Patients with positive human immunodeficiency virus
(HIV) antibody
10) Patients with uncontrollable cardiac diseases [New York
Heart Association (NYHA) Functional Classification Class
III or IV] or uncontrollable diabetes (including skin
ulceration) or uncontrollable hypertension
11) Patients with uncontrollable pain by analgesic drugs
12) Patients with a history of organ transplantation
13) Patients with hypothyroidism requiring treatment
14) Patients who have received another IMP,
immunosuppressant, bisphosphonate*3, or who have
received chemotherapy, hormone therapy, cytokine therapy,
surgery, radiotherapy, or photodynamic therapy for
treatment of the primary disease, or blood and/or albumin
transfusion within 4 weeks prior to the start of IMP
administration *3 If bisphosphonate has been used before 4 weeks prior to the start of
IMP administration, this drug may be used continuously if there is no
increase of the dose from 4 weeks prior to the start of IMP
administration to the final examination day of the final cycle.
15) Patients who have continuously received systemic
administration of corticosteroids, biguanide oral
antihyperglycemic drugs (such as metformin), drugs which
are cytochrome P450 (CYP) 3A4 inhibitors or inducers, or
foods and drinks which are possible cytochrome P450
(CYP) 3A4 inhibitors or inducers within 1 week prior to the
start of IMP administration
16) Patients with psychiatric diseases limiting the compliance
of clinical trial
17) Patients who are pregnant, possibly pregnant, or lactating
18) Patients otherwise judged by the investigator or
subinvestigator to be inappropriate for inclusion in the trial
The Estimated Number of Participants
-
Taiwan
10 participants
-
Global
42 participants
