A Dose Escalation Study of SCB01A in Subjects With Advanced Solid Tumors Who Have Failed Standard Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by SynCore Biotechnology Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
SynCore Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01159522
First received: June 23, 2010
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

The goal of this study with SCB01A is to determine the Maximum Tolerated Dose of SCB01A in patients with advanced solid tumors that have failed previous therapy.


Condition Intervention Phase
Solid Tumors
Drug: SCB01A
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Study of SCB01A in Subjects With Advanced Solid Tumors Who Have Failed Standard Therapy

Resource links provided by NLM:


Further study details as provided by SynCore Biotechnology Co., Ltd.:

Primary Outcome Measures:
  • To determine the maximum tolerated dose (MTD)in subjects with advanced solid tumor [ Time Frame: Each subject can be given up to 2 cycles of SCB01A. Each cycle will be 21 days. ] [ Designated as safety issue: Yes ]
    MTD is the dose at which at least two subjects experience the DLT; and DLT is defined as Grade 3 or greater Neutropenia, Thrombocytopenia, prolonged QTc, non-hematological adverse events and neurotoxicity

  • To determine DLT (Dose Limiting Toxicity) in subjects with advanced solid tumor [ Time Frame: Each subject can be given up to 2 cycles of SCB01A. Each cycle will be 21 days. ] [ Designated as safety issue: Yes ]
    DLT is defined as Grade 3 or greater Neutropenia, Thrombocytopenia, prolonged QTc, non-hematological adverse events and neurotoxicity


Secondary Outcome Measures:
  • Safety will be evaluated by physical examinations, vital signs, laboratory assessments, ECOG PS scale, and the incidence and severity of adverse events. [ Time Frame: ECOG-PS, AE's, physical examinations, vital signs, laboratory assessments will be assessed weekly. ] [ Designated as safety issue: Yes ]
  • For PK profile, blood samples will be collected at various time points [ Time Frame: PK blood samples will be taken immediately pre-infusion then at 1, 2, 3, 4, 6, 10, 21 and 24 hours after start of infusion on Day 1 ] [ Designated as safety issue: Yes ]
  • Tumor response will be assessed by RECIST v1.1 [ Time Frame: During screening and final visit ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SCB01A
This is an open-label, single-arm, dose-escalation, safety and tolerability study. Eligible subjects will be assigned to a SCB01A dose level at the time of study entry and scheduled to receive two treatment cycles with SCB01A for the observation of DLT. A treatment cycle is defined as a three-hour infusion of SCB01A given every 21 days. Unless any off-study criteria are met, the study period of each subject can be up to two cycles.
Drug: SCB01A
This is an open-label, single-arm, dose-escalation, safety and tolerability study. Eligible subjects will be assigned to a SCB01A dose level at the time of study entry and scheduled to receive two treatment cycles with SCB01A for the observation of DLT. A treatment cycle is defined as a three-hour infusion of SCB01A given every 21 days. Unless any off-study criteria are met, the study period of each subject can be up to two cycles.

Detailed Description:

This is an open-label, single-arm, dose-escalation, safety and tolerability study. Eligible subjects will be assigned to a SCB01A dose level at the time of study entry and scheduled to receive two treatment cycles with SCB01A for the observation of DLT. A treatment cycle is defined as a three-hour infusion of SCB01A given every 21 days. Unless any off-study criteria are met, the study period of each subject can be up to two cycles.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects who are at least 18 years of age.
  2. Have provided written informed consent prior to the initiation of study procedures.
  3. Have histologically or cytologically confirmed diagnosis of an advanced solid tumor that has failed to respond to all available standard treatments.
  4. Have ECOG PS scale of 0-1 at the time of enrollment.
  5. Have adequate organ function:

    1. Bone marrow function:

      • White blood cell count (WBC) ≥ 4000/μL
      • Absolute neutrophil count (ANC) ≥ 1500/μL
      • Hemoglobin ≥ 10.0 g/dL
      • Platelet count ≥ 100,000/μL
    2. Hepatic Function:

      • Serum total bilirubin level ≤ 1.0 x upper normal limit
      • Serum alanine aminotransferase (ALT) level ≤ 2.5 x upper normal limit
    3. Renal Function:

      • Serum creatinine ≤ 1.0 x upper normal limit and creatinine clearance (estimated by Cockcroft-Gault formula) > 60 mL/min

    4. Heart Function:

      • Ejection fraction ≥ 55%
      • QTC < 450 msec
  6. Have a life expectancy of at least 3 months
  7. Have negative serum pregnancy test within 1 week before study drug administration (for women of childbearing potential and not diagnosed as germ cell tumor with beta-HCG only).
  8. Are willing to practice medically accepted contraception (if the risk of contraception exists) throughout the study period (from screening until Final Visit).

Exclusion Criteria:

  1. Subjects who have failed to recover from prior anti-cancer treatment-related toxicities, e.g. surgery, chemotherapy, radiotherapy, target therapy, biologic therapy, immunotherapy, alternative medicine, hormonal therapy, or investigational agent(s).
  2. Treatment with an investigational drug, chemotherapy, targeting agent(s), biologic therapy (e.g., IL-2, Interferon, etc.), immunotherapy (e.g. tumor vaccine, etc.), alternative medicine or hormonal therapy (e.g. anti-estrogens, anti-androgens, etc.), radiation (except to bone) or surgery (except exploratory biopsy or intravenous device implantation, etc.) within 28 days prior to study entry.
  3. Grade 2 or higher sensory neuropathy of any etiology.
  4. Subjects with severe cardiopulmonary diseases (including history of stable, effort-induced or unstable angina pectoris, myocardial infarction, or arrhythmia) or other systemic diseases under poor control.
  5. Females who are pregnant, lactating, or have a positive serum pregnancy test except those are diagnosed as germ cell tumor with beta-HCG prior to study treatment. Pre-menopausal women who are not abstinent must prove surgical sterility or compliance with a contraceptive regimen. Male subjects and male partners of female subjects must be abstinent, surgically sterile, or utilizing a barrier contraceptive method.
  6. Tumor with central nervous system (CNS) involvement.
  7. Subjects with concomitant active 2nd primary malignancies or disease-free for no more than 3 years following a definitive therapy for prior metachronous malignancies, except for surgically cured carcinoma, i.e. in situ of the cervix or adequately treated basal cell carcinoma of the skin or Dukes' A colorectal cancer.
  8. Known history of allergy to any component of this investigational preparation.
  9. History of exposure to SCB01A or its analogs.
  10. Active infection requiring antibiotic therapy at time of study entry.
  11. Is unwilling or unable to comply with the protocol requirements.
  12. Known human immunodeficiency virus (HIV) infection.
  13. History of receiving organ transplantation or immunologic illness that require continuous immunosuppressant agent therapy.
  14. Have other medical or psychological conditions that would not permit the study participant to complete the study or sign informed consent.
  15. Have any other disease, dysfunction, alcohol or drug abuse, physical examination or lab finding that, in the investigator's opinion, would exclude the subject from the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159522

Contacts
Contact: Jolly Huang, MS 886-2-27603688 ext 2227 clhuang@syncorebio.com
Contact: Wan-Ting Huang, MS 886-2-27603688 ext 2190 wthuang@sinphar.com.tw

Locations
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan
Contact: Li-Tzong Chen, Ph.D.         
Principal Investigator: Li-Tzong Chen, MD, Ph.D.         
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Chia-Chi Lin, MD, Ph.D         
Principal Investigator: Chia-Chi Lin, MD, Ph.D         
Sponsors and Collaborators
SynCore Biotechnology Co., Ltd.
Investigators
Study Director: Muh-Hwan Su, Ph.D. SynCore Biotechnology
  More Information

No publications provided

Responsible Party: SynCore Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01159522     History of Changes
Other Study ID Numbers: SCB01A-01
Study First Received: June 23, 2010
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by SynCore Biotechnology Co., Ltd.:
Advanced Solid Tumors Who Have Failed Standard Therapy

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014