Solid TumorPhase 1/2NCT02890511
A Study DHP107, a Novel Oral Paclitaxel Formulation, in Patients With Advanced Solid Tumours or Gastric Cancer
A Phase 1/2 study testing Paclitaxel in people with Solid Tumor and Stage IV Gastric Cancer, run by Daehwa Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
A study of DHP107, a novel oral paclitaxel formulation, to determine maximum tolerated dose and recommended dose for phase II trial in patients with advanced solid cancer and explore efficacy of DHP107 in patients with gastric cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor, Stage IV Gastric Cancer
- What is being tested?
- Paclitaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Oct 2012
- Phase
- Phase 1/2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 70 years old
- Patients prognosed with advanced or metastatic solid cancer by histopathology or cytology analysis who have no available standard therapy or who have failed at least once with the standard therapy
- Adequate bone marrow function, liver function and adequate kidney function
- Eastern Cooperative Oncology Group performance status ≤ 2
- Life expectancy of 3 month or more
- Written informed consent
Who cannot join
- Major infectious or neurological disease and bowel obstruction
- Brain metastasis or hematologic malignancy
- Patients who underwent surgery, radiation therapy, hormone or chemotherapy within 4 weeks prior to the beginning of investigational drug administration
- Patients with the history of failure to the taxane line of chemotherapy (with the exception of when it was used before 6 month as adjuvant therapy or when the treatment was discontinued due to docetaxel related side effect)
- Patients who are required to continuously take P-gp (P-glycoprotein) suppressor, immune suppressor, proton-pump inhibitor or H2-receptor antagonist during clinical trial period
- Patients deemed by the investigator to suffer from severe heart disease (myocardial infarction, congestive heart failure, arrythmia accompanying drastic changes on ECG, severe or unstable angina pectoris, or other severe heart disease) or accompanying other severe internal diseases (such as uncontrollable diabetes, chronic obstructive pulmonary disease)
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- Patients with prior history of participating in a clinical trial within 30 days from registration for current clinical trial
- Patient with history of alcohol or drug abuse in the recent 3 months
- Pregnant women, nursing mothers, or patients of childbearing age who did not agree to contraception (both men and women)
- Patients with (or suspected to have) abnormality in bile acid secretion (e.g.,. patients with resected gallbladder)
- Patients who had a history of serious gastrointestinal bleeding, or with diseases that could affect the absorption of oral medication (malabsorption syndrome, active peptic ulcer)
- Patients with history of severe hypersensitive reaction to active ingredient and excipient of the investigational drug
- Patient who are in a state that is deemed inappropriate to participate in the clinical trial by the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 138-736
About this study
Official title: A Study of DHP107, a Novel Oral Paclitaxel Formulation, to Determine Maximum Tolerated Dose and Recommended Dose for Phase II Trial in Patients With Advanced Solid Cancer
A study of DHP107, a novel oral paclitaxel formulation, to determine maximum tolerated dose and recommended dose for phase II trial in patients with advanced solid cancer and explore efficacy of DHP107 in patients with gastric cancer
Read the detailed description
- Primary objective To determine the maximum tolerated dose and the recommended dose for phase 2 clinical trial for the repeated administration of DHP107 (oral paclitaxel) on advanced solid cancer patients
- Secondary objectives
- To identify the dose limiting toxicity and the safety (toxicity) of DHP107
- To evaluate the efficacy (tumor response rate) of DHP107
- To assess pharmacokinetic (PK) characteristics of DHP107
- Conditions
- Solid Tumor, Stage IV Gastric Cancer
- Being tested
- Paclitaxel
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called DHP107
Oral administration on day 1,8,15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed consent.
| Study group | Role | What they receive |
|---|---|---|
| DHP107(Oral paclitaxel) | Experimental | * Phase I (determining MTD) The patients diagnosed with either advanced or metastatic solid cancers were enrolled. The administered dose was escalated in a step-wise manner by an increment of 2 x 50 mg/m2 at each dose level. Three patients were treated for toxicity evaluation for each dose level.
* Phase IIa (efficacy evaluation) The safety and efficacy of the corresponding dose was investigated more closely by increasing the patient number to 6 or more patients in the dose tentatively determined as recommended dose for phase IIa clinical trial. Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicity(DLT) to determine maximum tolerated dose(MTD)
To determine the dose at which no more than one patient out of up to 6 patients at the same dose level experience a drug-related dose-limiting toxicity
Measured: First cycle of treatment (4-week)
Secondary outcomes (3)
To identify the dose limiting toxicity(DLT) and the safety (toxicity) of DHP107
Adverse events are evaluated in the first cycle(4-week) according to NCI CTCAE v4.0
Measured: First cycle of treatment (4-week)
To evaluate efficacy(tumor response) by RECIST criteria version 1.1
Measured: every 8 weeks (±1 week)
PK parameters for DHP107 derived from determining their plasma concentrations using validated assays.
Measured: First cycle of treatment (4-week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startAug 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daehwa Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoon-Koo Kang, M.D., Ph.D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890511
- Sponsor's protocol ID
- 107CS-2
- Status last verified
- Feb 2017
- First submitted
- 29 Aug 2016
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ryu MH, Ryoo BY, Kim TW, Kim SB, Lim HS, Bae KS, Park SR, Jo YW, Cho HJ, Kang YK. A Phase I/IIa Study of DHP107, a Novel Oral Paclitaxel Formulation, in Patients with Advanced Solid Tumors or Gastric Cancer. Oncologist. 2017 Feb;22(2):129-e8. doi: 10.1634/theoncologist.2016-0273. Epub 2017 Feb 14.
PubMed 28196905
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of DHP107, a Novel Oral Paclitaxel Formulation, to Determine Maximum Tolerated Dose and Recommended Dose for Phase II Trial in Patients With Advanced Solid Cancer
- ClinicalTrials.gov ID
- NCT02890511
- Acronym / sponsor ID
- 107CS-2
- Conditions
- Solid Tumor, Stage IV Gastric Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Daehwa Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 7 Sep 2016 (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.
A study of DHP107, a novel oral paclitaxel formulation, to determine maximum tolerated dose and recommended dose for phase II trial in patients with advanced solid cancer and explore efficacy of DHP107 in patients with gastric cancer
Detailed description
- Primary objective To determine the maximum tolerated dose and the recommended dose for phase 2 clinical trial for the repeated administration of DHP107 (oral paclitaxel) on advanced solid cancer patients
- Secondary objectives
- To identify the dose limiting toxicity and the safety (toxicity) of DHP107
- To evaluate the efficacy (tumor response rate) of DHP107
- To assess pharmacokinetic (PK) characteristics of DHP107
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DHP107(Oral paclitaxel) | Experimental | Drug: Paclitaxel* Phase I (determining MTD) The patients diagnosed with either advanced or metastatic solid cancers were enrolled. The administered dose was escalated in a step-wise manner by an increment of 2 x 50 mg/m2 at each dose level. Three patients were treated for toxicity evaluation for each dose level. * Phase IIa (efficacy evaluation) The safety and efficacy of the corresponding dose was investigated more closely by increasing the patient number to 6 or more patients in the dose tentatively determined as recommended dose for phase IIa clinical trial. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients between 18 and 70 years old
- Patients prognosed with advanced or metastatic solid cancer by histopathology or cytology analysis who have no available standard therapy or who have failed at least once with the standard therapy
- Adequate bone marrow function, liver function and adequate kidney function
- Eastern Cooperative Oncology Group performance status ≤ 2
- Life expectancy of 3 month or more
Key exclusion criteria (13 listed)
- Major infectious or neurological disease and bowel obstruction
- Brain metastasis or hematologic malignancy
- Patients who underwent surgery, radiation therapy, hormone or chemotherapy within 4 weeks prior to the beginning of investigational drug administration
- Patients with the history of failure to the taxane line of chemotherapy (with the exception of when it was used before 6 month as adjuvant therapy or when the treatment was discontinued due to docetaxel related side effect)
- Patients who are required to continuously take P-gp (P-glycoprotein) suppressor, immune suppressor, proton-pump inhibitor or H2-receptor antagonist during clinical trial period
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 |
|---|---|---|
| PaclitaxelAlso: DHP107Oral administration on day 1,8,15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed consent. | Drug | DHP107(Oral paclitaxel) |
Primary outcome
Number of participants with dose limiting toxicity(DLT) to determine maximum tolerated dose(MTD)
Time frame: First cycle of treatment (4-week)
To determine the dose at which no more than one patient out of up to 6 patients at the same dose level experience a drug-related dose-limiting toxicity
3 secondary outcomes
To identify the dose limiting toxicity(DLT) and the safety (toxicity) of DHP107
Time frame: First cycle of treatment (4-week)
To evaluate efficacy(tumor response) by RECIST criteria version 1.1
Time frame: every 8 weeks (±1 week)
PK parameters for DHP107 derived from determining their plasma concentrations using validated assays.
Time frame: First cycle of treatment (4-week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Derived from this study: PubMed 28196905Ryu MH, Ryoo BY, Kim TW, Kim SB, Lim HS, Bae KS, Park SR, Jo YW, Cho HJ, Kang YK. A Phase I/IIa Study of DHP107, a Novel Oral Paclitaxel Formulation, in Patients with Advanced Solid Tumors or Gastric Cancer. Oncologist. 2017 Feb;22(2):129-e8. doi: 10.1634/theoncologist.2016-0273. Epub 2017 Feb 14.
- Individual participant dataSharing planned: No
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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.
Yoon-Koo Kang, M.D., Ph.D principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Paclitaxel in people with Solid Tumor and Stage IV Gastric Cancer, run by Daehwa Pharmaceutical Co., Ltd. at 1 site in South Korea.
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 6 inclusion and 13 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: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with dose limiting toxicity(DLT) to determine maximum tolerated dose(MTD) (time frame: First cycle of treatment (4-week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02890511, which also lists 1 linked publication.
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 13 Feb 2017.