Locally Advanced TumorsPhase 1NCT02228811
A Study of DCC-2701 in Participants With Advanced Solid Tumors
A Phase 1 study testing DCC-2701 tablet in people with Locally Advanced Tumors and Metastatic Solid Tumors, run by Deciphera Pharmaceuticals, LLC at 5 sites in United States.
Trial summary
The main purpose of this study is to investigate the safety of the investigational drug DCC-2701 and whether it will work to help people who have advanced solid tumors or cancer that has spread to other parts of the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Tumors, Metastatic Solid Tumors, Cancers With MET Genomic Alterations
- What is being tested?
- DCC-2701 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2014to Jan 2018
- 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
- Advanced or metastatic solid tumor that has progressed or was not responsive to standard therapy
- The cancer has no proven effective therapy
- The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required)
- Able to swallow tablets
Who cannot join
- Have active central nervous system (CNS) metastasis
- Have an active infection of any kind (fungal, viral, or bacterial)
- Are pregnant or breastfeeding
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado Hospital
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
MD Anderson Cancer Center
Houston, Texas, 77030
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Multicenter Phase 1 Ascending Dose Study of DCC-2701 To Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Solid Tumors
The main purpose of this study is to investigate the safety of the investigational drug DCC-2701 and whether it will work to help people who have advanced solid tumors or cancer that has spread to other parts of the body.
Read the detailed description
This is a first-in-human study of DCC-2701. The primary purpose of this study is to determine what dose of DCC-2701, can be given safely to patients with advanced solid tumors.
The study will have two phases. The first phase will assess escalating doses of DCC-2701 in order to determine the maximally tolerated dose (MTD) and the optimal dosing regimen (ODR) of DCC-2701. Once the MTD and ODR is established, a dose expansion phase will further evaluate the safety of DCC-2701, as well as the activity of DCC-2701 in select solid tumor types.
- Conditions
- Locally Advanced Tumors, Metastatic Solid Tumors, Cancers With MET Genomic Alterations, Cancers With TRK Genomic Alterations
- Being tested
- DCC-2701 tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCC-2701 tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| DCC-2701 tablet | Experimental | DCC-2701 tablets in escalating dose cohorts given orally BID (twice daily) every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met. Receives: Drug: DCC-2701 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of DCC-2701
Measured: 28 days (1 cycle)
Secondary outcomes (4)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of DCC-2701
Measured: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of DCC-2701
Measured: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of DCC-2701
Measured: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
Number of Participants with Tumor Response according to Response Evaluations Criteria in Solid Tumors (RECIST) version 1.1
Measured: Baseline through study completion (estimated as 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced TumorsStudies of the same condition, open and under way.
- More trials run by Deciphera Pharmaceuticals, LLCThe sponsor's other registered studies.
- 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deciphera Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oliver Rosen, M.D., Study director, Deciphera Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228811
- Sponsor's protocol ID
- DCC-2701-01-001
- Status last verified
- Dec 2016
- First submitted
- 27 Aug 2014
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase 1 Ascending Dose Study of DCC-2701 To Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02228811
- Acronym / sponsor ID
- DCC-2701-01-001
- Conditions
- Locally Advanced Tumors, Metastatic Solid Tumors, Cancers With MET Genomic Alterations, Cancers With TRK Genomic Alterations
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Deciphera Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 29 Aug 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.
The main purpose of this study is to investigate the safety of the investigational drug DCC-2701 and whether it will work to help people who have advanced solid tumors or cancer that has spread to other parts of the body.
Detailed description
This is a first-in-human study of DCC-2701. The primary purpose of this study is to determine what dose of DCC-2701, can be given safely to patients with advanced solid tumors.
The study will have two phases. The first phase will assess escalating doses of DCC-2701 in order to determine the maximally tolerated dose (MTD) and the optimal dosing regimen (ODR) of DCC-2701. Once the MTD and ODR is established, a dose expansion phase will further evaluate the safety of DCC-2701, as well as the activity of DCC-2701 in select solid tumor types.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCC-2701 tablet | Experimental | Drug: DCC-2701 tabletDCC-2701 tablets in escalating dose cohorts given orally BID (twice daily) every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced or metastatic solid tumor that has progressed or was not responsive to standard therapy
- The cancer has no proven effective therapy
- The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required)
- Able to swallow tablets
Key exclusion criteria (3 listed)
- Have active central nervous system (CNS) metastasis
- Have an active infection of any kind (fungal, viral, or bacterial)
- Are pregnant or breastfeeding
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 |
|---|---|---|
| DCC-2701 tablet | Drug | DCC-2701 tablet |
Primary outcome
Maximum Tolerated Dose (MTD) of DCC-2701
Time frame: 28 days (1 cycle)
4 secondary outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of DCC-2701
Time frame: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of DCC-2701
Time frame: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of DCC-2701
Time frame: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
Number of Participants with Tumor Response according to Response Evaluations Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Baseline through study completion (estimated as 18 months)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
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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.
Oliver Rosen, M.D. study director
Deciphera Pharmaceuticals, LLC
5 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 DCC-2701 tablet in people with Locally Advanced Tumors and Metastatic Solid Tumors, run by Deciphera Pharmaceuticals, LLC at 5 sites 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 4 inclusion and 3 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 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 was stopped early. 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?
Maximum Tolerated Dose (MTD) of DCC-2701 (time frame: 28 days (1 cycle)). 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 1 Feb 2018.