CancerPhase 1NCT02151357
Safety, Tolerability and Pharmacokinetics of DCBCI0901 in Patients With Advanced Solid Tumor
A Phase 1 study testing DCBCI0901 in people with Cancer, run by Standard Chem. & Pharm. Co., Ltd. at 3 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- DCBCI0901
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesTaiwan
- Study dates
- 19 Aug 2014to 31 Oct 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- If there is a history of brain metastases or spinal cord compression treated with radiation and/or surgery, the therapy must have occurred at least 3 months prior to enrollment and the metastatic disease must have been stable since completion.
- Patients who are fully informed about the content of the study by the Investigator using the specified written consent form
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei, 100
Taipei Veterans General Hospital
Taipei
About this study
Official title: Phase I, Sequential Dose Escalation Clinical Study to Investigate the Safety, Tolerability and Pharmacokinetics of in Patients With Advanced Solid Tumor
- 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).
Read the detailed description
This is a Phase I, open label, first in human study designed to evaluate the safety, tolerability and PK of escalating doses of DCBCI0901 in patients with advanced solid tumors. Each treatment cycle will be 28 days in duration with no gap between cycles. During each cycle, DCBCI0901 will be administered slowly as a 30 minute intravenous (IV) infusion (use of infusion pump preferred) once daily (QD) in the first 5 day dosing period (Days 1 to 5), which will be followed by 9 days of recovery and observation (Days 6 14). DCBCI0901 will be administered intravenously QD in a second 5 day dosing period (Days 15 through 19), followed again by 9 days of recovery and observation (Days 20 through 28).
Patients may continue to receive treatment in 28 day cycles after completion of Cycle 1. To qualify for continued treatment beyond Cycle 1, all of the following criteria must be fulfilled:
- The patient is willing to receive further treatment
- Toxicity induced by the IP is not considered to be unbearable as judged by the Investigator
- The patient does not have PD as defined by Response Evaluation Criteria in Solid Tumors
- The patient satisfies the criteria for dosing
- The patient does not meet any of the criteria for withdrawal
After the first cycle, CT/MRI assessment will be performed once every 8 weeks (2 cycles) for efficacy evaluation, or per Investigator judgment. After the first year of treatment, the Investigator will assess the patient using CT/MRI based on his/her discretion.
Safety data will be evaluated according to normal practice.
Upon discontinuation of study treatment (if applicable), assessments for the Early termination visit (if discontinuation occurs in Cycle 1) or End of Treatment visit (if discontinuation occurs in Cycle 2 or onwards) should occur within 3 days of discontinuation. Assessments for the Follow up visit (10 days [±1 day] after the last dose of IP) and End of Study (EOS) visit (30 days [±3 days] after the last dose of IP)
- Conditions
- Cancer
- Being tested
- DCBCI0901
- Keywords
- first in man, dose escalating, MTD, DLT
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCBCI0901Drug
DCBCI0901 7.5mg/m2 iv infusion for day 1 to day 5 and day 15 to day 20
| Study group | Role | What they receive |
|---|---|---|
| DCBCI0901 | Experimental | DCBCI0901 7.5mg/m2, iv infusion for day 1-day 5 and day 15-day 20 Receives: Drug: DCBCI0901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: one year
Secondary outcomes (1)
• Pharmacokinetic parameters as described below will be calculated for DCBCI0901, if data permit.
Pharmacokinetic parameters will be determined from DCBCI0901 plasma concentrations using noncompartmental methods. DCBCI0901 PK parameters to be calculated (if adequate data are available for estimation) will include Cmax, time to Cmax (tmax), applicable AUC parameters such as AUC from time zero to the last quantifiable time point (AUC(0 last)), AUC from time zero to infinity (AUC(0 inf)), and/or AUC over the dosing interval tau (AUC(0 tau)), terminal half life (t1/2), systemic clearance (CL), steady state volume of distribution and volume of distribution in the terminal phase (Vss and Vz, respectively), and multiple/single dose accumulation parameters for Cmax and AUC (RCmax and RAUC).
Measured: 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study start19 Aug 2014
- Primary completion24 Jun 2016
- Study completion31 Oct 2016
Why it stopped: catheter occlusion events during the study drug infusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Standard Chem. & Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chia-Chi Lin, Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151357
- Sponsor's protocol ID
- DCBCI 0901 101
- Status last verified
- Oct 2017
- First submitted
- 27 May 2014
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Sequential Dose Escalation Clinical Study to Investigate the Safety, Tolerability and Pharmacokinetics of in Patients With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT02151357
- Acronym / sponsor ID
- DCBCI 0901 101
- Conditions
- Cancer
- Keywords
- first in man, dose escalating, MTD, DLT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: catheter occlusion events during the study drug infusion
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Standard Chem. & Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2014 (actual)
- Primary completion
- 24 Jun 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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).
Detailed description
This is a Phase I, open label, first in human study designed to evaluate the safety, tolerability and PK of escalating doses of DCBCI0901 in patients with advanced solid tumors. Each treatment cycle will be 28 days in duration with no gap between cycles. During each cycle, DCBCI0901 will be administered slowly as a 30 minute intravenous (IV) infusion (use of infusion pump preferred) once daily (QD) in the first 5 day dosing period (Days 1 to 5), which will be followed by 9 days of recovery and observation (Days 6 14). DCBCI0901 will be administered intravenously QD in a second 5 day dosing period (Days 15 through 19), followed again by 9 days of recovery and observation (Days 20 through 28).
Patients may continue to receive treatment in 28 day cycles after completion of Cycle 1. To qualify for continued treatment beyond Cycle 1, all of the following criteria must be fulfilled:
- The patient is willing to receive further treatment
- Toxicity induced by the IP is not considered to be unbearable as judged by the Investigator
- The patient does not have PD as defined by Response Evaluation Criteria in Solid Tumors
- The patient satisfies the criteria for dosing
- The patient does not meet any of the criteria for withdrawal
After the first cycle, CT/MRI assessment will be performed once every 8 weeks (2 cycles) for efficacy evaluation, or per Investigator judgment. After the first year of treatment, the Investigator will assess the patient using CT/MRI based on his/her discretion.
Safety data will be evaluated according to normal practice.
Upon discontinuation of study treatment (if applicable), assessments for the Early termination visit (if discontinuation occurs in Cycle 1) or End of Treatment visit (if discontinuation occurs in Cycle 2 or onwards) should occur within 3 days of discontinuation. Assessments for the Follow up visit (10 days [±1 day] after the last dose of IP) and End of Study (EOS) visit (30 days [±3 days] after the last dose of IP)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCBCI0901 | Experimental | Drug: DCBCI0901DCBCI0901 7.5mg/m2, iv infusion for day 1-day 5 and day 15-day 20 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCBCI0901DCBCI0901 7.5mg/m2 iv infusion for day 1 to day 5 and day 15 to day 20 | Drug | DCBCI0901 |
Primary outcome
• Investigate the safety and tolerability of multiple DCBCI0901 infusions in patients with advanced solid tumor
Time frame: one year
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.
1 secondary outcome
• Pharmacokinetic parameters as described below will be calculated for DCBCI0901, if data permit.
Time frame: 28
Results and safety
The study was stopped early (reason given: catheter occlusion events during the study drug infusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Chi Lin, Ph.D. principal investigator
National Taiwan University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DCBCI0901 in people with Cancer, run by Standard Chem. & Pharm. Co., Ltd. at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: catheter occlusion events during the study drug infusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Investigate the safety and tolerability of multiple DCBCI0901 infusions in patients with advanced solid tumor (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.