Solid TumorPhase 1NCT02049281
A Study of Vintafolide (MK-8109) in Participants With Advanced Solid Tumor (MK-8109-011)
A Phase 1 study testing Vintafolide in people with Solid Tumor, run by Endocyte.
Trial summary
This study will evaluate thrice weekly dosing with vintafolide to find the maximum tolerable dose. The primary study hypothesis is that administration of vintafolide to participants with advanced solid tumors will have acceptable safety and tolerability. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Vintafolide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to May 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
Who cannot join
- Chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to drug administration (6 weeks for nitrosoureas or mitomycin C) or not recovered from adverse events due to agents administered more than 4 weeks earlier
- Primary central nervous system (CNS) tumor
- Active CNS metastases and/or carcinomatous meningitis
- Known hypersensitivity to the components of the study therapy or its analogs
- Recent history of abdominal surgery or peritonitis
- Bowel occlusion or sub occlusion
Show all 10Show fewer
- Prior abdominal or pelvis radiation therapy or radiation therapy to > 10% of the bone marrow at any time in the past or prior radiation therapy within the last three years to the breast / sternum, head, or neck
- Requires anti-folate therapy
- Symptomatic ascites or pleural effusion
- Prior stem cell or bone marrow transplant
About this study
Official title: A Phase I Dose Escalation Study Evaluating MK-8109 (Vintafolide) in Japanese Subjects With Advanced Solid Tumor
This study will evaluate thrice weekly dosing with vintafolide to find the maximum tolerable dose. The primary study hypothesis is that administration of vintafolide to participants with advanced solid tumors will have acceptable safety and tolerability.
- Conditions
- Solid Tumor
- Being tested
- Vintafolide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VintafolideDrug
Also called MK-8109
Intravenous (IV) bolus, starting dose 1.4 mg, on Days 1, 3, 5, 15, 17, and 19 of each 28-day cycle for up to 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Vintafolide | Experimental | Participants receive vintafolide intravenous (IV) bolus, starting dose 1.4 mg, on Days 1, 3, 5, 15, 17, and 19 of each 28-day cycle for up to 6 cycles. Receives: Drug: Vintafolide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Dose-limiting Toxicities
Measured: Up to 28 days
Secondary outcomes (3)
Maximum Plasma Concentration (Cmax) of Vintafolide
Measured: Cycle 1, Day1 predose and at 2, 5, 10, 20, 30, 45, 60, 90 and 120 minutes post-dose
Area Under the Plasma Concentration-time Curve (AUC) for Vintafolide
Measured: Cycle 1, Day1 predose and at 2, 5, 10, 20, 30, 45, 60, 90 and 120 minutes post-dose
Plasma Concentration of desacetylvinblastine hydrazide (DAVLBH)
Measured: Cycle 1, Day1 predose and at 2, 5, 10, 20, 30, 45, 60, 90 and 120 minutes post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endocyte
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049281
- Sponsor's protocol ID
- 8109-011
- Other IDs
- 142501
- Status last verified
- Feb 2015
- First submitted
- 28 Jan 2014
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study Evaluating MK-8109 (Vintafolide) in Japanese Subjects With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT02049281
- Acronym / sponsor ID
- 8109-011
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- EndocyteIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Jan 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.
This study will evaluate thrice weekly dosing with vintafolide to find the maximum tolerable dose. The primary study hypothesis is that administration of vintafolide to participants with advanced solid tumors will have acceptable safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vintafolide | Experimental | Drug: VintafolideParticipants receive vintafolide intravenous (IV) bolus, starting dose 1.4 mg, on Days 1, 3, 5, 15, 17, and 19 of each 28-day cycle for up to 6 cycles. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
Key exclusion criteria (10 listed)
- Chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to drug administration (6 weeks for nitrosoureas or mitomycin C) or not recovered from adverse events due to agents administered more than 4 weeks earlier
- Primary central nervous system (CNS) tumor
- Active CNS metastases and/or carcinomatous meningitis
- Known hypersensitivity to the components of the study therapy or its analogs
- Recent history of abdominal surgery or peritonitis
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 |
|---|---|---|
| VintafolideAlso: MK-8109Intravenous (IV) bolus, starting dose 1.4 mg, on Days 1, 3, 5, 15, 17, and 19 of each 28-day cycle for up to 6 cycles. | Drug | Vintafolide |
Primary outcome
Number of Participants Experiencing Dose-limiting Toxicities
Time frame: Up to 28 days
3 secondary outcomes
Maximum Plasma Concentration (Cmax) of Vintafolide
Time frame: Cycle 1, Day1 predose and at 2, 5, 10, 20, 30, 45, 60, 90 and 120 minutes post-dose
Area Under the Plasma Concentration-time Curve (AUC) for Vintafolide
Time frame: Cycle 1, Day1 predose and at 2, 5, 10, 20, 30, 45, 60, 90 and 120 minutes post-dose
Plasma Concentration of desacetylvinblastine hydrazide (DAVLBH)
Time frame: Cycle 1, Day1 predose and at 2, 5, 10, 20, 30, 45, 60, 90 and 120 minutes post-dose
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 10 Feb 2015.
Related trials for Solid Tumor
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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vintafolide in people with Solid Tumor, run by Endocyte.
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 3 inclusion and 10 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 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of Participants Experiencing Dose-limiting Toxicities (time frame: Up to 28 days). 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 10 Feb 2015.