Phase I clinical trial of JPH203 in patients with solid cancers.
- Conditions
- Solid cancers
- Registration Number
- JPRN-UMIN000016546
- Lead Sponsor
- J-Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 21
Not provided
1) Patient with severe disorders and/or unstable complications except cancers evaluated by investigator, and psychopathy impeding informed consent, study and subject safety 2) Patient with infection required systemic therapy 3) Patient with positive HIV-1 or HCV antibody, or HBs antigen 4) Patient with ECG abnormality 5) Patient with pleural fluids, pericardial effusions or ascites required drainage 6) Patient with brain metastasis or cancerous body fluid seen by imaging. 7) Patient receiving irradiation over 1/3 of hematopoietic bone 8) Patient with frequent diarrhea or watery stool 9) Pregnant or nursing pregnant patients disagreed with contraception 90 days after last receipt of study drug. 10) Patient with continuously systemic steroid therapy 11) Patient received cyto-reductive chemotherapy, irradiation and immune therapy within 4 weeks before the trial 12) Patient whom investigator evaluates unsuitable
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Safety According to CTCAE Ver.4, category and grade of adverse effect (AE) are evaluated. All AEs, frequency of AE higher than grade 3 and relationship between AE and the study drug are estimated. 2) Estimation of maximal tolerated dose (MTD), and dose limited toxicity (DLT). 3) Determination of recommended dose (DR) for next phase trial.
- Secondary Outcome Measures
Name Time Method