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Advanced CancerPhase 1NCT01688791

A Study of MK-8109 (Vintafolide) Given Alone or With Chemotherapy in Participants With Advanced Cancers (MK-8109-001)

A Phase 1 study testing Vintafolide, Carboplatin and Paclitaxel in people with Advanced Cancer, run by Endocyte.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This trial will be conducted in three parts. Part A is a dose escalation trial followed by a dose confirmation trial in folate receptor (FR) 100% endometrial cancer participants. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer
What is being tested?
Vintafolide, Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
No sites listed yet
Study dates
Dec 2012to Sep 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 18 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 or is unacceptable to the participant
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • At least one measurable metastatic or recurrent lesion
  • No history of a previous malignancy with the exception of cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or adequately treated localized prostate carcinoma; or has undergone potentially curative therapy with no evidence of disease for five years
  • Adequate organ function
  • Female participants of childbearing potential must be willing to use acceptable methods of birth control or abstain from heterosexual activity for the course of the study through 90 days after the last dose of study therapy
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  • Male participants must agree to use an adequate method of contraception for heterosexual activity starting with the first dose of study therapy through 90 days after the last dose of study therapy
  • Tumor lesions characterized as folate receptor (FR) 100% as determined by an etarfolide Sequential Single Photon Emission Computed Tomography (SPECT) and CT scan
  • Histologically-confirmed diagnosis of locally advanced or metastatic or recurrent endometrial cancer
  • Must have an etarfolatide SPECT/CT scan to determine FR status

Who cannot join

  • Part A \& Part C if enrolled after completion of Part B: Chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to drug administration, or not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Part B: Chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 3 weeks prior to drug administration, or not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Currently participating or has participated in a study with an investigational compound or device within 28 days of initial dosing on this study
  • Part A, dose escalation, Parts B and C: More than 3 prior cytotoxic regimens for metastatic disease.
  • Part A, dose confirmation: Has received more than 2 prior cytotoxic regimens for metastatic disease.
  • Primary central nervous system (CNS) tumor
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  • Active CNS metastases and/or carcinomatous meningitis.
  • Known hypersensitivity to the components of the study therapy or its analogs
  • Recent (i.e., ≤ 6 weeks) history of abdominal surgery or peritonitis
  • Bowel occlusion or sub-occlusion
  • Prior whole abdominal or whole 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 3 years to the breast / sternum, head, or neck
  • Requires anti-folate therapy for the management of co-morbid conditions
  • Known regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse
  • Pregnant or breastfeeding or expecting to conceive, or donate sperm within the span of the study
  • Human Immunodeficiency Virus (HIV)-positive
  • Active Hepatitis B or C
  • Symptomatic ascites or pleural effusion.
  • History of stem cell or bone marrow transplant
  • Permanent pacemaker
  • Unable to refrain from use of all concomitant medications on Day 1
  • Structural heart disease, history of myocardial infarction (MI), or unstable angina
  • History of cardiac arrhythmia, congestive heart failure (CHF), sick sinus syndrome, second or third degree atrioventricular (AV) block
  • History of risk factors for Torsades de Pointes such as CHF, uncorrected hypokalemia, family history of long QT syndrome

About this study

Official title: A Phase I Dose Escalation Study Evaluating Vintafolide (MK-8109) Chemotherapy Alone or in Combination in Adult Subjects With Advanced Cancers

This trial will be conducted in three parts. Part A is a dose escalation trial followed by a dose confirmation trial in folate receptor (FR) 100% endometrial cancer participants. The primary hypothesis of this trial is that administration of vintafolide in combination with carboplatin and paclitaxel is safe and tolerable. Part B is a single dose, dose escalation, pharmacokinetic (PK), and QTc interval trial. The primary objectives include determination of the maximum single tolerated dose of vintafolide and to evaluate the effect of this single maximum dose on the QTc interval. Part C is a weekly dose escalation trial of vintafolide followed by a dose confirmation. The primary hypothesis of this part is that weekly vintafolide has acceptable safety and tolerability in participants with advanced cancers.

Conditions
Advanced Cancer
Being tested
Vintafolide, Carboplatin, Paclitaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01688791
Study groupRoleWhat they receive
Part A: Vintafolide BIWExperimentalVintafolide, intravenously (IV), on Days 1, 4, 8, and 11 of each 21-day cycle. Carboplatin, IV, at a dose of area under the curve (AUC)5, administered on Day 1 of each 21-day cycle. Paclitaxel, IV, at a dose of 175 mg/m^2, administered on Day 1 of each 21-day cycle
Receives: Drug: Vintafolide; Drug: Carboplatin; Drug: Paclitaxel
Part A: Vintafolide TIWExperimentalVintafolide, intravenously (IV) on Days 1, 3, 5, 8, 10, and 12 of each 21-day cycle. Carboplatin, IV, at a dose of area under the curve (AUC)5, administered on Day 1 of each 21-day cycle. Paclitaxel, IV, at a dose of 175 mg/m^2, administered on Day 1 of each 21-day cycle
Receives: Drug: Vintafolide; Drug: Carboplatin; Drug: Paclitaxel
Parts B & C: Vintafolide Single Dose & Weekly (QW)ExperimentalSingle dose, dose escalation, vintafolide (Part B) followed by 2 week observation. Those completing Part B will have the option to continue on to Part C (weekly dosing, dose finding, on Days 1, 8, and 15 in a 21-day cycle until disease progression or toxicity) unless they experience severe and/or persistent drug related toxicity.
Receives: Drug: Vintafolide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parts A and C: Number of participants with dose-limiting toxicities (DLTs)

    Measured: Cycle 1 (21 days)

  2. Part B: Change from Baseline in QTc interval

    Measured: 30 minutes pre-dose and up to 2 hours post-dose

  3. Part C: Number of Participants Experiencing an Adverse Event (AE)

    Measured: Up to 18 weeks (six 3-week cycles)

Secondary outcomes (5)

  1. Number of participants whose best response is partial response (PR) or complete response (CR)

    Measured: Week 6

  2. Progression free survival

    Measured: Week 6

  3. Disease control rate

    Measured: Week 6

  4. Part B: Pharmacokinetics (PK) of vintafolide, including Area Under the Curve (AUC) and Maximum Concentration (Cmax)

    Measured: Day 1

  5. Part B: PK of Vintafolide Metabolites, including AUC and Cmax

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01688791
Sponsor's protocol ID
8109-001
Other IDs
2012-002799-14
Status last verified
Feb 2015
First submitted
17 Sep 2012
Last updated
10 Feb 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vintafolide, Carboplatin and Paclitaxel in people with Advanced Cancer, 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 10 inclusion and 23 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?

Parts A and C: Number of participants with dose-limiting toxicities (DLTs) (time frame: Cycle 1 (21 days)). The study lists 3 primary outcomes in all. 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 NCT01688791.

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.

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