Pancreatic CancerPhase 1NCT02138383
Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer
A Phase 1 study testing Enzalutamide, Gemcitabine and Nab-paclitaxel in people with Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The main purpose of this study is to find out the dose of enzalutamide that can be safely given with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer. Researchers also want to find out the side effects of these drugs when given together. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Enzalutamide, Gemcitabine and Nab-paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2014to 7 Oct 2019
- 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
- Participants must have histologically or cytologically confirmed pancreatic adenocarcinoma that is metastatic or unresectable. In the dose expansion phase, the tumor must express Androgen Receptor (AR) by immunohistochemistry. If ≥1% of the tumor cells express AR, it will be considered positive for this trial.
- Must have measurable disease per Response Criteria in Solid Tumors (RECIST) criteria version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%)
- Life expectancy of greater than 3 months
- Must have normal organ and marrow function
- Prior treatment with gemcitabine alone or 5-Fluorouracil with radiation as an adjuvant therapy will be allowed; Should not have received gemcitabine within 6 months of starting the study treatment; 5-Fluorouracil or radiation treatment should be received more than 4 weeks prior to receiving the study drug.
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of the study treatment.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Prior treatment with any cytotoxic chemotherapy except as an adjuvant therapy. Participant should not have received gemcitabine within 6 months of starting the study treatment. 5-Fluorouracil or radiation treatment should be received more than 4 weeks prior to receiving the study drug.
- May not be receiving any other investigational agents within 4 weeks of starting the study treatment and during the study period.
- Untreated brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel or enzalutamide.
- Have undergone major surgery within 4 weeks prior to starting the study treatment.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; history of myocardial infarction within 6 months of starting study treatment.
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- Known history of human immunodeficiency virus (HIV) infection or active hepatitis B or hepatitis C
- Any history of seizure. History of loss of consciousness or transient ischemic attack within 12 months of starting the study drug.
- Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control
- Chronic treatment with immunosuppressant drugs
- Other malignancy requiring active treatment
- Any significant medical condition, laboratory abnormality, or psychiatric illness, that would prevent participating in the study, including the inability to swallow capsules
- Any active infection not controlled by antibiotics
- Concomitant medications that lower seizure threshold
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase I Trial With Cohort Expansion of Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer
The main purpose of this study is to find out the dose of enzalutamide that can be safely given with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer. Researchers also want to find out the side effects of these drugs when given together. This study will help in finding out the effect on tumor of the combination of enzalutamide, gemcitabine and nab-paclitaxel. In the first part of the study, different doses of enzalutamide will be tested. In the second part of the study, all patients will be started at the same dose of enzalutamide.
- Conditions
- Pancreatic Cancer
- Being tested
- Enzalutamide, Gemcitabine, Nab-paclitaxel
- Keywords
- advanced pancreatic cancer, pancreas, malignant neoplasm, endocrine system
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
Also called MDV3100, XTANDI®, androgen receptor (AR) antagonist
The starting dose of enzalutamide will be 80 mg (Level 1) daily, taken orally. The dose escalation schedule is a standard 3 + 3 design. In the first part of the study, different doses of enzalutamide will be tested. In the second part of the study, all patients will be started at the same dose of enzalutamide.
GemcitabineDrug
Also called nucleoside inhibitor, GEMZAR®
The starting dose of gemcitabine will be 1000 mg/m^2 administered intravenously on days 1, 8 and 15 of each cycle.
Nab-paclitaxelDrug
Also called albumin bound paclitaxel, microtubule inhibitor, Abraxane®
The starting dose of nab-paclitaxel will be 125 mg/m^2 administered intravenously on days 1, 8 and 15 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation and Dose Expansion | Experimental | Dose Escalation: To find the dose of enzalutamide that can be safely given with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer.
Dose Expansion: To find the effect on tumor of the combination of enzalutamide, gemcitabine and nab-paclitaxel. Receives: Drug: Enzalutamide; Drug: Gemcitabine; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
To determine the maximally tolerated dose (MTD) of enzalutamide in combination with gemcitabine and nab-paclitaxel in advanced pancreatic cancer.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study start22 May 2014
- Primary completion15 Dec 2016
- Study completion7 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Richard Kim, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138383
- Sponsor's protocol ID
- MCC-17696
- Status last verified
- Aug 2021
- First submitted
- 12 May 2014
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial With Cohort Expansion of Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02138383
- Acronym / sponsor ID
- MCC-17696
- Conditions
- Pancreatic Cancer
- Keywords
- advanced pancreatic cancer, pancreas, malignant neoplasm, endocrine system
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- 22 May 2014 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 14 May 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 find out the dose of enzalutamide that can be safely given with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer. Researchers also want to find out the side effects of these drugs when given together. This study will help in finding out the effect on tumor of the combination of enzalutamide, gemcitabine and nab-paclitaxel. In the first part of the study, different doses of enzalutamide will be tested. In the second part of the study, all patients will be started at the same dose of enzalutamide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation and Dose Expansion | Experimental | Drug: Enzalutamide, Drug: Gemcitabine, Drug: Nab-paclitaxelDose Escalation: To find the dose of enzalutamide that can be safely given with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer. Dose Expansion: To find the effect on tumor of the combination of enzalutamide, gemcitabine and nab-paclitaxel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must have histologically or cytologically confirmed pancreatic adenocarcinoma that is metastatic or unresectable. In the dose expansion phase, the tumor must express Androgen Receptor (AR) by immunohistochemistry. If ≥1% of the tumor cells express AR, it will be considered positive for this trial.
- Must have measurable disease per Response Criteria in Solid Tumors (RECIST) criteria version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%)
- Life expectancy of greater than 3 months
- Must have normal organ and marrow function
Key exclusion criteria (14 listed)
- Prior treatment with any cytotoxic chemotherapy except as an adjuvant therapy. Participant should not have received gemcitabine within 6 months of starting the study treatment. 5-Fluorouracil or radiation treatment should be received more than 4 weeks prior to receiving the study drug.
- May not be receiving any other investigational agents within 4 weeks of starting the study treatment and during the study period.
- Untreated brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel or enzalutamide.
- Have undergone major surgery within 4 weeks prior to starting the study treatment.
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 |
|---|---|---|
| EnzalutamideAlso: MDV3100, XTANDI®, androgen receptor (AR) antagonistThe starting dose of enzalutamide will be 80 mg (Level 1) daily, taken orally. The dose escalation schedule is a standard 3 + 3 design. In the first part of the study, different doses of enzalutamide will be tested. In the second part of the study, all patients will be started at the same dose of enzalutamide. | Drug | Dose Escalation and Dose Expansion |
| GemcitabineAlso: nucleoside inhibitor, GEMZAR®The starting dose of gemcitabine will be 1000 mg/m^2 administered intravenously on days 1, 8 and 15 of each cycle. | Drug | Dose Escalation and Dose Expansion |
| Nab-paclitaxelAlso: albumin bound paclitaxel, microtubule inhibitor, Abraxane®The starting dose of nab-paclitaxel will be 125 mg/m^2 administered intravenously on days 1, 8 and 15 of each cycle. | Drug | Dose Escalation and Dose Expansion |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: Up to 18 months
To determine the maximally tolerated dose (MTD) of enzalutamide in combination with gemcitabine and nab-paclitaxel in advanced pancreatic cancer.
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 17 Aug 2021.
- Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.
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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.
Richard Kim, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
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 Enzalutamide, Gemcitabine and Nab-paclitaxel in people with Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute 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 8 inclusion and 14 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 17 Aug 2021. 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?
Maximum Tolerated Dose (MTD) (time frame: Up to 18 months). 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 17 Aug 2021.