Pancreatic CancerPhase 1NCT02155088
BYL719 in Combination With Gemcitabine and (Nab)-Paclitaxel in Locally Advanced and Metastatic Pancreatic Cancer
A Phase 1 study testing BYL719, 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 see primarily if BYL719 is safe to be given to patients in combination with gemcitabine and nab-paclitaxel. Gemcitabine and nab-paclitaxel is an FDA-approved regimen to treat pancreatic cancer. 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?
- BYL719, Gemcitabine and (nab)-paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2014to 31 Jan 2020
- 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
- Patient is able to swallow and retain oral medication
- Histologically documented diagnosis of pancreatic adenocarcinoma.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Required baseline laboratory status according to protocol document
Who cannot join
- Prior sensitivity or intolerance to PI3K inhibitors
- Potential participants with central nervous system (CNS) involvement may participate if the patient is: >/= 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment; Clinically stable with respect to the CNS tumor at the time of screening; Not receiving steroid therapy.
- Prior treatment with any cytotoxic chemotherapy for treatment of pancreatic cancer except as an adjuvant therapy. 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.
- Potential participants who have received radiotherapy ≤ 4 weeks prior to starting study drugs, with exception of palliative radiotherapy, who have not recovered from side effects of such therapy to baseline or Grade ≤ 1 and/or from whom ≥ 30% of the bone marrow was irradiated.
- Potential participants who have undergone major surgery ≤ 4 weeks prior to starting study treatment or who have not recovered from side effects of such procedure.
- Have received investigation agent within 30 days prior to enrollment
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- Clinically significant cardiac disease or impaired cardiac function
- QT interval adjusted according to Fredericia (QTcF) > 480 msec on screening ECG
- Potential participants with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting plasma glucose (FPG)> 140 mg/dL or history of documented steroid-induced diabetes mellitus.
- Any other condition that would, in the Investigator's judgment, preclude participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, unable to swallow oral medication, social/psychological complications.
- Impaired GI function or GI disease that may significantly alter the absorption of oral BYL719 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- Liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-DNA and/or positive HbsAg, quantifiable hepatitis C virus [HCV]-RNA).
- Known positive serology for human immunodeficiency virus (HIV)
- Known severely impaired lung function (spirometry and diffusing capacity of lung for carbon monoxide[DLCO] 50% or less of normal and O2 saturation 88% or less at rest on room air).
- Currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
- Currently receiving treatment with drugs known to be strong inhibitors or inducers of isoenzyme CYP3A. Must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the start of treatment. Switching to a different medication prior to starting study treatment is allowed.
- Has a history of non-compliance to medical regimen or inability to grant consent
- Currently receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes (TdP) and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug treatment
- History of another malignancy requiring active treatment within 2 years prior to starting study treatment, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL)
- Participant who does not apply highly effective contraception during the study and through 12 weeks after final dose of study treatment
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 BYL719 in Combination With Gemcitabine and (Nab)-Paclitaxel in Locally Advanced and Metastatic Pancreatic Cancer
The main purpose of this study is to see primarily if BYL719 is safe to be given to patients in combination with gemcitabine and nab-paclitaxel. Gemcitabine and nab-paclitaxel is an FDA-approved regimen to treat pancreatic cancer. Secondary goals will be to find out the effect on tumor of this new drug combination of BYL719, gemcitabine and nab-paclitaxel. In the first part of the study, different doses of BYL719 will be tested. In the second part of the study, all patients will be started at the same dose of BYL719.
- Conditions
- Pancreatic Cancer
- Being tested
- BYL719, Gemcitabine, (nab)-paclitaxel
- Keywords
- Locally Advanced, Metastatic, Recurrent, Pancreas
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BYL719Drug
Also called a-specific P13K inhibitor
Dose escalation beginning at 250 mg/day
GemcitabineDrug
Also called Gemzar
Dose escalation beginning at 800 mg/m^2
(nab)-paclitaxelDrug
Also called Abraxane
125 mg/m^2 dose
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy: BYL719, Gemcitabine, (Nab)-Paciltaxel | Experimental | Dose escalation, followed by expansion, of BYL719 in combination with Gemcitabine and (Nab)-Paclitaxel. BYL719: once daily. Gemcitabine: Days 1,8, 15 of 28-day cycle. (Nab)-Paclitaxel: Days 1,8, 15 of 28-day cycle. Receives: Drug: BYL719; 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)
The MTD is defined as the highest dose level at which one or none of 6 patients experience a Dose Limiting Toxicity (DLT).
Measured: Up to 4 months per participant
Secondary outcomes (3)
Overall Response Rate (ORR)
Complete Response plus Partial Response (CR+PR). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Up to 3 years
Overall Survival (OS)
Overall survival of patients who receive at least one dose of the study drug at MTD.
Measured: Up to 3 years
Progression-Free Survival (PFS)
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study start30 Oct 2014
- Primary completion1 Dec 2016
- Study completion31 Jan 2020
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
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- 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
- NCT02155088
- Sponsor's protocol ID
- MCC-17815
- Status last verified
- Apr 2021
- First submitted
- 2 Jun 2014
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial With Cohort Expansion of BYL719 in Combination With Gemcitabine and (Nab)-Paclitaxel in Locally Advanced and Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02155088
- Acronym / sponsor ID
- MCC-17815
- Conditions
- Pancreatic Cancer
- Keywords
- Locally Advanced, Metastatic, Recurrent, Pancreas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 30 Oct 2014 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 4 Jun 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 see primarily if BYL719 is safe to be given to patients in combination with gemcitabine and nab-paclitaxel. Gemcitabine and nab-paclitaxel is an FDA-approved regimen to treat pancreatic cancer. Secondary goals will be to find out the effect on tumor of this new drug combination of BYL719, gemcitabine and nab-paclitaxel. In the first part of the study, different doses of BYL719 will be tested. In the second part of the study, all patients will be started at the same dose of BYL719.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy: BYL719, Gemcitabine, (Nab)-Paciltaxel | Experimental | Drug: BYL719, Drug: Gemcitabine, Drug: (nab)-paclitaxelDose escalation, followed by expansion, of BYL719 in combination with Gemcitabine and (Nab)-Paclitaxel. BYL719: once daily. Gemcitabine: Days 1,8, 15 of 28-day cycle. (Nab)-Paclitaxel: Days 1,8, 15 of 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is able to swallow and retain oral medication
- Histologically documented diagnosis of pancreatic adenocarcinoma.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Required baseline laboratory status according to protocol document
Key exclusion criteria (21 listed)
- Prior sensitivity or intolerance to PI3K inhibitors
- Potential participants with central nervous system (CNS) involvement may participate if the patient is: >/= 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment; Clinically stable with respect to the CNS tumor at the time of screening; Not receiving steroid therapy.
- Prior treatment with any cytotoxic chemotherapy for treatment of pancreatic cancer except as an adjuvant therapy. 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.
- Potential participants who have received radiotherapy ≤ 4 weeks prior to starting study drugs, with exception of palliative radiotherapy, who have not recovered from side effects of such therapy to baseline or Grade ≤ 1 and/or from whom ≥ 30% of the bone marrow was irradiated.
- Potential participants who have undergone major surgery ≤ 4 weeks prior to starting study treatment or who have not recovered from side effects of such procedure.
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 |
|---|---|---|
| BYL719Also: a-specific P13K inhibitorDose escalation beginning at 250 mg/day | Drug | Combination Therapy: BYL719, Gemcitabine, (Nab)-Paciltaxel |
| GemcitabineAlso: GemzarDose escalation beginning at 800 mg/m^2 | Drug | Combination Therapy: BYL719, Gemcitabine, (Nab)-Paciltaxel |
| (nab)-paclitaxelAlso: Abraxane125 mg/m^2 dose | Drug | Combination Therapy: BYL719, Gemcitabine, (Nab)-Paciltaxel |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: Up to 4 months per participant
The MTD is defined as the highest dose level at which one or none of 6 patients experience a Dose Limiting Toxicity (DLT).
3 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 3 years
Progression-Free Survival (PFS)
Time frame: Up to 3 years
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 8 Apr 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 BYL719, 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 4 inclusion and 21 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 8 Apr 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 4 months per participant). 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 8 Apr 2021.