Safety, Tolerability and Pharmacokinetics of DCBCI0901 in Patients With Advanced Solid Tumor

NCT02151357 | Terminated Phase 1

• 1 other identifier: DCBCI 0901 101
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

• Investigate the safety and tolerability of multiple DCBCI0901 infusions in patients with advanced solid tumor
• Pharmacokinetic parameters will be calculated for DCBCI0901, if data permit.
• Anti tumor activity: The efficacy endpoint will be the overall response rate (ORR) defined as the proportion of patients who continuously receive treatment after Cycle 1 with a best overall response of complete response (CR) or partial response (PR).

Conditions

Cancer

Keywords

first in man; dose escalating; MTD; DLT

Outcome Measures

Primary Outcomes (1)

• • Investigate the safety and tolerability of multiple DCBCI0901 infusions in patients with advanced solid tumor

  AE and SAE, physical examination, vital signs, weight, clinical laboratory examinations (hematology, blood chemistry, blood coagulation, and urinalysis), pulmonary function tests, pulse oximetry, and ECGs. Adverse events and SAEs will be collected from the time of informed consent, throughout the study, until the EOS visit or up to 1 year of treatment.

  one year

Secondary Outcomes (1)

• • Pharmacokinetic parameters as described below will be calculated for DCBCI0901, if data permit.

  28

Other Outcomes (1)

• •Anti tumor activity

  one year

Study Arms (1)

DCBCI0901

EXPERIMENTAL

DCBCI0901 7.5mg/m2, iv infusion for day 1-day 5 and day 15-day 20

Drug: DCBCI0901

Interventions

DCBCI0901 DRUG

DCBCI0901 7.5mg/m2 iv infusion for day 1 to day 5 and day 15 to day 20

DCBCI0901

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female patients, age at consent ≥20 years.
• Patients with pathologically or cytologically confirmed advanced solid tumor(s), failed to respond to standard therapy.
• Measurable or non measurable disease on imaging by RECIST v1.1.
• ECOG PS of 0 and 1.
• Any acute or chronic clinically significant adverse effects of prior chemotherapy have resolved to ≤Grade 1 as determined by the CTCAE v4.0 criteria.
• Life expectancy ≥12 weeks.
• No prior cytotoxic chemotherapy, radiation therapy, or immunosuppressive therapy within 4 weeks of starting study treatment.
• Have not participated in any other investigational trials within 28 days before commencing the study treatment.
• Eligible organ function
• Patients with primary liver cancer or hepatic metastasis are eligible to enroll,
• No active infections or unstable angina, or myocardial infarction within 6 months or coexisting medical problems of sufficient severity to limit compliance in the study.
• No known concomitant genetic or acquired immunosuppressive diseases
• No history of alcoholism, drug addiction or psychotic disorders.
• Negative urine β human chorionic gonadotropin test in women of childbearing potential at Screening.
• Patients who agree that they or their partner(s), if WOCBP, will practice contraception during the study period

You may not qualify if:

• Uncontrolled systemic infection at Screening, including patients who are positive and at risk
• Severe or poorly controlled systemic illnesses that may affect the conduct or results of the study.
• Presence of ≥Grade 2 non hematological AEs at Screening for which a causal relationship with prior therapies cannot be ruled out
• Long QT syndrome,
• Symptoms of peripheral neuropathy.
• Concomitant treatment with, or anticipated use of, pharmaceutical, non pharmaceutical agents which are known potent inhibitors for Cytochrome P450
• Patients on traditional Chinese medicine (TCM) or plan to take TCM.
• Women who are nursing or pregnant during the study period.
• Patients who have a history of hypersensitivity to mTOR inhibitors or any of the ingredients.
• Patients who cannot communicate reliably with the Investigator.
• Patients who are unlikely to cooperate with the requirements of the study.
• Other cases judged by the Investigator to be ineligible for participation in the study.

Sponsors & Collaborators

• Standard Chem. & Pharm. Co., Ltd.: lead

Study Sites (3)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Chia-Chi Lin, Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 30, 2014
• Study Start: August 19, 2014
• Primary Completion: June 24, 2016
• Study Completion: October 31, 2016
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

TW (3)