Pancreatic CancerPhase 2NCT04386057
LY3214996 +/- HCQ in Pancreatic Cancer
A Phase 2 study testing Hydroxychloroquine Sulfate and LY3214996 in people with Pancreatic Cancer and Advanced Cancer, run by Kimberly Perez, MD at 4 sites in United States.
Trial summary
This study is evaluating the safety and efficacy of combining the study drug LY3214996 with hydroxychloroquine sulfate (HCQ) in patients with advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Advanced Cancer
- What is being tested?
- Hydroxychloroquine Sulfate and LY3214996
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 May 2020to 5 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 adenocarcinoma or poorly differentiated carcinoma of the pancreas.
- Age ≥ 18 years.
- ECOG performance status ≤ 1
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for nonnodal lesions and short axis for nodal lesions) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan, MRI, or calipers by clinical exam.
- Participants must have received at least one but no more than two prior lines of systemic therapy for metastatic pancreatic cancer. Perioperative treatment (chemotherapy and/or radiation) is not considered a prior line of therapy.
- Participants must have adequate organ and marrow function as defined below:
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- Absolute Neutrophil Count ≥ 1,500/mcL
- Platelet Count ≥ 100,000/mcL
- Total Bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
- AST (SGOT) / ALT(SGPT) ≤ 2.5 × institutional ULN, OR
- AST (SGOT) / ALT (SGPT) ≤ 5 × institutional ULN if elevation is a result of metastases
- Creatinine ≤ 1.5 × institutional ULN, OR
- Creatinine Clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels above 1.5 × institutional normal (calculated via the Cockcroft-Gault equation)
- The effects of LY3214996 or HCQ on the developing human fetus are unknown. For this reason and because anti-cancer agents are known to be teratogenic, women of child bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 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 6 months after completion of LY3214996 or HCQ administration.
- Ability to understand and the willingness to sign a written informed consent document.
- Ability to swallow and retain oral medication
- Baseline QTcB of ≤ 470 msec on screening EKG.
- Participants must be able and willing to undergo the pre-treatment biopsy procedure, and have a cancer site amenable to biopsy.
Who cannot join
- Participants with pancreatic histologies other than adenocarcinoma or poorly differentiated carcinoma, such as neuroendocrine or acinar cell carcinoma.
- Participants who have received a prior MAPK pathway inhibitor, including but not limited to LY3214996.
- Participants who have had systemic chemotherapy, other investigational therapy, or immunotherapy within 3 weeks prior to the first dose of study medication.
- Participants who have received oral tyrosine kinase inhibitors (TKIs) within 5 half-lives of the first dose of study medication.
- Participants who have received radiation therapy within 2 weeks prior to the first dose of study medication.
- Participants who have had major surgery within 4 weeks prior to the first dose of study medication.
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- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to LY3214996 or HCQ. Individuals with a history of a different malignancy are ineligible with the following exceptions: individuals who have been treated and are disease-free for a minimum of 3 years prior to study enrollment, or individuals who are deemed by the treating investigator to be at low risk for disease recurrence. Additionally, individuals with the following cancers are eligible if diagnosed and curatively treated within the past 3 years: basal or squamous cell carcinomas of the skin, and breast or cervical carcinomas in situ.
- 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.
- Pregnant women are excluded from this study because LY3214996 and HCQ are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with LY3214996 or HCQ, breastfeeding should be discontinued if the mother is treated with LY3214996 or HCQ. A negative serum pregnancy test is required for women of childbearing potential prior to the first dose of study medication.
- Participants who are known to be seropositive for human immunodeficiency virus (HIV) or hepatitis B or C.
- Participants with a history or findings of central or branch retinal artery or venous occlusion with significant vision loss, or other retinal diseases causing visual impairment or would likely cause visual impairment over the time period of the study, as assessed by an ophthalmologist.
- Participants with a known personal or family history of long QT syndrome.
- Participants with known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Participants who are known at the time of trial enrollment to require concomitant treatment with strong CYP3A4 inhibitors or inducers. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
Official title: Phase II Trial of ERK Inhibition Alone and in Combination With Autophagy Inhibition in Patients With Metastatic Pancreatic Cancer
This study is evaluating the safety and efficacy of combining the study drug LY3214996 with hydroxychloroquine sulfate (HCQ) in patients with advanced pancreatic cancer.
Read the detailed description
- This is an open label, randomized, two arm, phase II with safety lead- in study exploring the anti-tumor activity of the extracellular signal-regulated kinase (ERK) inhibitor LY3214996 with and without hydroxychloroquine (HCQ) in patients with advanced pancreatic cancer.
- The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
- The safety lead-in will test the safety of a combination of investigational drugs and also try to define appropriate dosage. The names of the study drugs involved in this study are:
- LY3214996
- Hydroxychloroquine Sulfate (HCQ)
- Following completion of a brief combination treatment safety lead-in cohort, participants will be randomized 1:1 for enrollment to one of two treatment arms:
- Arm 1: receiving combination treatment with LY3214996 and HCQ
- Arm 2: receiving monotherapy treatment with LY3214996
It is expected that about 52 people will take part in this research study
The U.S. Food and Drug Administration (FDA) has not approved LY3214996 as a treatment for any disease.
The U.S. Food and Drug Administration (FDA) has not approved HCQ for your specific disease but it has been approved for other uses.
- Conditions
- Pancreatic Cancer, Advanced Cancer
- Being tested
- Hydroxychloroquine Sulfate, LY3214996
- Keywords
- Pancreatic Cancer, Advanced Cancer, Extracellular Signal-Regulated Kinases, Cell Growth Inhibitors
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine SulfateDrug
Also called Plaquenil®), HCQ
HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle
LY3214996Drug
LY3214996-daily oral dosage per protocol per 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Safety Lead-In Cohort | Experimental | The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis.
Test the safety of study drugs in combination and define dose levels.
* LY3214996
* HCQ Receives: Drug: Hydroxychloroquine Sulfate; Drug: LY3214996 |
| LY3214996 and HCQ Combination | Experimental | The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Combined dosage per determined Lead-In Cohort
* LY3214996
* HCQ Receives: Drug: Hydroxychloroquine Sulfate; Drug: LY3214996 |
| LY3214996-Monotherapy | Experimental | The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days.Treatment will be administered on an outpatient basis.
-LY3214996 Receives: Drug: LY3214996 |
| Cross Over Arm | Experimental | Participants who are enrolled to Arm 2 who experience radiologic disease progression on monotherapy will have the option to cross-over to receive treatment with the combination. Crossover will occur at the treating investigator's discretion following consultation and approval from the overall principal investigator. Combined dosage per determined Lead-In Cohort
* LY3214996
* HCQ Receives: Drug: Hydroxychloroquine Sulfate; Drug: LY3214996 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate (DCR)
Anti-tumor activity will be measured via disease control rate (DCR), which will be defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) that persists for ≥ 4 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: 28 Months
Dose Limiting Toxicity-Lead In
Dose Limiting Toxicity-Lead In
Measured: 28 Days
Secondary outcomes (3)
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the number of participants who had a complete or partial response at any time during treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.
Measured: 28 Months
Progression-free Survival (PFS)
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study . The sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesion and/or unequivocal progression of existing non-target lesions are also considered progression. Unequivocal progression should not normally trump target lesion status and must be representative of overall disease status change, not a single lesion increase.
Measured: time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation up to 28 Months
Overall Survival (OS)
Kaplan and Meier to assess Overall survival (OS)
Measured: Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. OS was calculated for a median of 115 days, ranging from 18 - 327 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start27 May 2020
- Primary completion9 Aug 2023
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kimberly Perez, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor-investigator, Kimberly Perez, MD, Dana-Farber Cancer Institute
- Investigators
- Kimberly Perez, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386057
- Sponsor's protocol ID
- 19-529
- Status last verified
- Jan 2025
- First submitted
- 10 May 2020
- Last updated
- 12 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of ERK Inhibition Alone and in Combination With Autophagy Inhibition in Patients With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04386057
- Acronym / sponsor ID
- 19-529
- Conditions
- Pancreatic Cancer, Advanced Cancer
- Keywords
- Pancreatic Cancer, Advanced Cancer, Extracellular Signal-Regulated Kinases, Cell Growth Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kimberly Perez, MDUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 27 May 2020 (actual)
- Primary completion
- 9 Aug 2023 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Posted 27 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is evaluating the safety and efficacy of combining the study drug LY3214996 with hydroxychloroquine sulfate (HCQ) in patients with advanced pancreatic cancer.
Detailed description
- This is an open label, randomized, two arm, phase II with safety lead- in study exploring the anti-tumor activity of the extracellular signal-regulated kinase (ERK) inhibitor LY3214996 with and without hydroxychloroquine (HCQ) in patients with advanced pancreatic cancer.
- The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
- The safety lead-in will test the safety of a combination of investigational drugs and also try to define appropriate dosage. The names of the study drugs involved in this study are:
- LY3214996
- Hydroxychloroquine Sulfate (HCQ)
- Following completion of a brief combination treatment safety lead-in cohort, participants will be randomized 1:1 for enrollment to one of two treatment arms:
- Arm 1: receiving combination treatment with LY3214996 and HCQ
- Arm 2: receiving monotherapy treatment with LY3214996
It is expected that about 52 people will take part in this research study
The U.S. Food and Drug Administration (FDA) has not approved LY3214996 as a treatment for any disease.
The U.S. Food and Drug Administration (FDA) has not approved HCQ for your specific disease but it has been approved for other uses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Safety Lead-In Cohort | Experimental | Drug: Hydroxychloroquine Sulfate, Drug: LY3214996The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ |
| LY3214996 and HCQ Combination | Experimental | Drug: Hydroxychloroquine Sulfate, Drug: LY3214996The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ |
| LY3214996-Monotherapy | Experimental | Drug: LY3214996The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days.Treatment will be administered on an outpatient basis. -LY3214996 |
| Cross Over Arm | Experimental | Drug: Hydroxychloroquine Sulfate, Drug: LY3214996Participants who are enrolled to Arm 2 who experience radiologic disease progression on monotherapy will have the option to cross-over to receive treatment with the combination. Crossover will occur at the treating investigator's discretion following consultation and approval from the overall principal investigator. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Participants must have histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the pancreas.
- Age ≥ 18 years.
- ECOG performance status ≤ 1
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for nonnodal lesions and short axis for nodal lesions) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan, MRI, or calipers by clinical exam.
- Participants must have received at least one but no more than two prior lines of systemic therapy for metastatic pancreatic cancer. Perioperative treatment (chemotherapy and/or radiation) is not considered a prior line of therapy.
Key exclusion criteria (15 listed)
- Participants with pancreatic histologies other than adenocarcinoma or poorly differentiated carcinoma, such as neuroendocrine or acinar cell carcinoma.
- Participants who have received a prior MAPK pathway inhibitor, including but not limited to LY3214996.
- Participants who have had systemic chemotherapy, other investigational therapy, or immunotherapy within 3 weeks prior to the first dose of study medication.
- Participants who have received oral tyrosine kinase inhibitors (TKIs) within 5 half-lives of the first dose of study medication.
- Participants who have received radiation therapy within 2 weeks prior to the first dose of study medication.
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 |
|---|---|---|
| Hydroxychloroquine SulfateAlso: Plaquenil®), HCQHCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle | Drug | Cross Over Arm, LY3214996 and HCQ Combination, Safety Lead-In Cohort |
| LY3214996LY3214996-daily oral dosage per protocol per 28 day cycle | Drug | Cross Over Arm, LY3214996 and HCQ Combination, LY3214996-Monotherapy, Safety Lead-In Cohort |
Primary outcome
Disease Control Rate (DCR)
Time frame: 28 Months
Anti-tumor activity will be measured via disease control rate (DCR), which will be defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) that persists for ≥ 4 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Dose Limiting Toxicity-Lead In
Time frame: 28 Days
Dose Limiting Toxicity-Lead In
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: 28 Months
Progression-free Survival (PFS)
Time frame: time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation up to 28 Months
Overall Survival (OS)
Time frame: Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. OS was calculated for a median of 115 days, ranging from 18 - 327 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Kimberly Perez, MD principal investigator
Dana-Farber Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine Sulfate and LY3214996 in people with Pancreatic Cancer and Advanced Cancer, run by Kimberly Perez, MD at 4 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 18 inclusion and 15 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 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disease Control Rate (DCR) (time frame: 28 Months). The study lists 2 primary outcomes in all. 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 12 Feb 2025.