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A Phase 1, Open-label, Non-randomized, Dose-escalation Trial of OPB-51602 in Patients With Advanced Solid Tumors

Phase 1
21 Years
Open (Enrolling)
Malignant Solid Tumour

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Trial Information

A Phase 1, Open-label, Non-randomized, Dose-escalation Trial of OPB-51602 in Patients With Advanced Solid Tumors

In expansion stage part 1, up to 20 advanced sold tumor subjects will be investigated the
safety profiled and antitumor effect of OPB-51602 at the recommended dose for 3 weeks per
cycle(2 weeks treatment and 1 week washout). In the expansion stage part 2, a maximum of 20
subjects with Non-small cell lung cancer (NSCLC), Melanoma or Gastrointestinal Stromal Tumor
(GIST) will be treated until an investigational Medicinal product (IMP) efficacious case can
be found. subject dosing will be started on Day 1 without 2-day treatment free interval and
continued until Day 28 at recommend dose (4mg) first in cycle 1. After safety and
tolerability are confirmed, same subjects will be treated at the MTD(5mg) from cycle 2
onwards as a once-daily oral dose for 4 weeks per cycle to obtain additional information
about safety, tolerability and antitumor activity of OPB-51602

Inclusion Criteria:

- Patients with pathologically confirmed, locally advanced or metastatic solid tumors
who are unresponsive to standard therapy or for whom standard therapy is intolerable
or unsuitable

- Age: ≥21 years (at time of informed consent)

- ECOG performance status: ≤2 (Appendix 1)

- Life expectancy of longer than 3 months

- Adequate vital organ function as follows:

1. Bone marrow function Neutrophils: ≥1,500/μL, platelets: ≥75,000/μL, hemoglobin:
≥9.0 g/dL

2. Hepatic function Aspartate transaminase (AST) and alanine transaminase(ALT):
≤2.5 ×institutional upper limit of normal(ULN) or ≤5.0 × institutional ULN if
there is liver metastasis, serum total bilirubin: <2.5 × institutional ULN

3. Renal function Serum creatinine: <1.5 × institutional ULN

- Capable of swallowing OPB-51602 tablets

- Ability to understand and willingness to sign written informed consent form (ICF) for
participation in the trial

- No chemotherapy, radiotherapy, surgery, immunotherapy, or other therapy within 4
weeks prior to start of investigational medicinal product (IMP) administration and
recovered from any prior toxicity

- If a subject has received more than 5 regimens of previous chemotherapy, the
investigator must discuss with the sponsor regarding subject suitability prior to

Exclusion Criteria:

- Uncontrolled central nervous system (CNS) metastasis

- Uncontrolled concurrent illness, including active infection, angina pectoris, cardiac
arrhythmia, or heart failure (NYHA class III or IV, Appendix 2 New York Heart
Association (NYHA) functional classification)

- Concurrent malignancy of a different type

- Immunocompromised subjects, including those who are known to be infected with human
immunodeficiency virus (HIV)

- Psychiatric illness that would limit compliance with trial requirements

- Pregnant or breast-feeding women

- Women of childbearing potential (WOCBP) or male subjects whose partners are WOCBP who
cannot or will not use effective contraceptive measures

- Administration of another investigational agent within 6 weeks prior to start of IMP

- Use of any of the prohibited medications and other substances listed in Appendix 3
CYP3A4 Inhibitors and Inducers within either 1 week prior to start of IMP
administration or a period of at least 5 times the respective elimination halflife,
whichever is longer

- Known severe gastrointestinal disorder, including malabsorption (at screening)

- Patients with CTCAE Grade 1 or higher pneumonitis (interstitial pneumonia) or
pulmonary fibrosis* * If interstitial lung abnormalities, (e.g. 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 dose not fall under this exclusion criterion before the patient can be
enrolled in the trial.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety and tolerability

Outcome Description:

AEs, vital signs, body weight, ECG, clinical laboratory tests, and ECOG performances status in the first cycle of treatment

Outcome Time Frame:

3 weeks

Safety Issue:


Principal Investigator

Goh Boon Cher, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Haematology-Oncology,National University Hospital


Singapore: Health Sciences Authority

Study ID:




Start Date:

December 2009

Completion Date:

October 2013

Related Keywords:

  • Malignant Solid Tumour
  • Advanced solid tumor
  • Neoplasms