Solid TumorsPhase 1NCT00839631
Dose Escalation Study of EC D-3263 HCl in Advanced Solid Tumors
A Phase 1 study testing EC D-3263 HCl in people with Solid Tumors, run by Dendreon at 1 site in United States.
Trial summary
This is a Phase 1, dose escalation study evaluating safety and pharmacokinetics of enteric coated D-3263 HCl in subjects with advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- EC D-3263 HCl
- Type of treatment
- Pill or oral medicine
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Apr 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically or cytologically confirmed advanced solid tumor malignancy which is either refractory to standard therapy or for which no standard therapy exists
- measurable or evaluable disease
- >= 18 years of age
- ECOG of 0, 1 or 2
- no treatement with chemotherapy, radiotherapy or other systemic therapy (excluding depot LHRH agonist or antagonist for subjects with prostate cancer) for the treatment of his or her tumor with in 28 days prior to receipt of EC D-3263 HCl
Who cannot join
- Clinically significant coronary artery disease or conduction system abnormality
- Coagulation disorder
- Active infection requiring the use of systemic antimicrobial medications within seven days prior to receipt of EC D-3263 HCl
- Any major surgery within 28 days prior to receipt of EC D-3263 HCl
Trial locations and contacts
1 site in 1 country.
United States1 site
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229
About this study
Official title: A Phase 1, Open Label, Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Enteric Coated D-3263 Hydrochloride in Subjects With Advanced Solid Tumors
This is a Phase 1, dose escalation study evaluating safety and pharmacokinetics of enteric coated D-3263 HCl in subjects with advanced solid tumors
- Conditions
- Solid Tumors
- Being tested
- EC D-3263 HCl
- Keywords
- subjects with advanced solid tumors refractory to standard therapy or for whom no effective therapy is available.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC D-3263 HClDrug
EC D-3263 HCl, capsules, 50 mg. Oral administration. Dose escalation cohorts (cycle one: single dose on Day 1, daily doses on day 8-28; subsequent cycles: 1 week drug holiday followed by 3 weeks of daily dosing). Expansion Cohort: daily dosing for 28 days followed by a single 7 day drug holiday (Cycle 1), continuing thereafter with daily dosing.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety of EC D-3263 HCl
Measured: weekly
Determine the maximum tolerated dose of EC D-3263 HCl administered orally daily
Measured: weekly
Secondary outcomes (2)
Characterize the pharmacokinetic profile of EC D-3263 HCl after a single dose and repeat daily dosing
Measured: periodically within the first month, weekly thereafter
preliminary assessment of antitumor activity
Measured: 1 month, periodically thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dendreon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839631
- Sponsor's protocol ID
- T08-1
- Status last verified
- Apr 2012
- First submitted
- 6 Feb 2009
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Enteric Coated D-3263 Hydrochloride in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00839631
- Acronym / sponsor ID
- T08-1
- Conditions
- Solid Tumors
- Keywords
- subjects with advanced solid tumors refractory to standard therapy or for whom no effective therapy is available.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- DendreonIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 9 Feb 2009 (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.
This is a Phase 1, dose escalation study evaluating safety and pharmacokinetics of enteric coated D-3263 HCl in subjects with advanced solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- histologically or cytologically confirmed advanced solid tumor malignancy which is either refractory to standard therapy or for which no standard therapy exists
- measurable or evaluable disease
- >= 18 years of age
- ECOG of 0, 1 or 2
- no treatement with chemotherapy, radiotherapy or other systemic therapy (excluding depot LHRH agonist or antagonist for subjects with prostate cancer) for the treatment of his or her tumor with in 28 days prior to receipt of EC D-3263 HCl
Key exclusion criteria (4 listed)
- Clinically significant coronary artery disease or conduction system abnormality
- Coagulation disorder
- Active infection requiring the use of systemic antimicrobial medications within seven days prior to receipt of EC D-3263 HCl
- Any major surgery within 28 days prior to receipt of EC D-3263 HCl
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 |
|---|---|---|
| EC D-3263 HClEC D-3263 HCl, capsules, 50 mg. Oral administration. Dose escalation cohorts (cycle one: single dose on Day 1, daily doses on day 8-28; subsequent cycles: 1 week drug holiday followed by 3 weeks of daily dosing). Expansion Cohort: daily dosing for 28 days followed by a single 7 day drug holiday (Cycle 1), continuing thereafter with daily dosing. | Drug | – |
Primary outcome
Assess the safety of EC D-3263 HCl
Time frame: weekly
Determine the maximum tolerated dose of EC D-3263 HCl administered orally daily
Time frame: weekly
2 secondary outcomes
Characterize the pharmacokinetic profile of EC D-3263 HCl after a single dose and repeat daily dosing
Time frame: periodically within the first month, weekly thereafter
preliminary assessment of antitumor activity
Time frame: 1 month, periodically thereafter
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 2 May 2012.
Related trials for Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EC D-3263 HCl in people with Solid Tumors, run by Dendreon at 1 site in United States.
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 5 inclusion and 4 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 2 May 2012. 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 United States. 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 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?
Assess the safety of EC D-3263 HCl (time frame: weekly). The study lists 2 primary outcomes in all. 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 2 May 2012.