Pancreatic CancerPhase 2NCT05212025
Adavosertib and Gemcitabine in Advanced Pancreatic
A Phase 2 study testing Adavosertib and Gemcitabine in people with Pancreatic Cancer, run by James Cleary, MD, PhD.
Trial summary
This study is being done to test the safety and effectiveness of combining Adavosertib and Gemcitabine in patients with pancreatic cancer. The names of the study drugs involved in this study are: Adavosertib Gemcitabine 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?
- Adavosertib and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to 31 Dec 2023
- Phase
- Phase 2
- 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 a histologically confirmed advanced pancreatic adenocarcinoma that is not curable with standard approaches based on the judgement of the treating investigator. Patients with metastatic pancreatic cancer and unresectable pancreatic cancer are eligible.
- Patients must have progressed on a platinum-based regimen prior to enrolling on the trial.
- Patients must have received no more than 1 prior lines of platinum-based chemotherapy in the metastatic setting. Therapy given in the adjuvant or neoadjuvant setting is counted as a prior therapy if it occurred less than 6 months before cancer recurrence or progression.
- Age ≥ 18 years. As no dosing or adverse event data are currently available in participants < 18 years of age, children and adolescents are excluded from this study.
- ECOG performance status of 0 or 1 (see Appendix A).
- Participants must have adequate organ and marrow function as defined below:
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- Absolute neutrophil count ≥ 1,500/mm3
- Platelets ≥ 100,000/mm3
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN); or total bilirubin ≤3.0 x ULN with direct bilirubin WNL in patients with documented Gilbert's Syndrome.
- Alanine aminotransferase (ALT) and ≤ 3 × institutional ULN; or ≤ 5 × institutional aspartate aminotransferase (AST) ULN if known hepatic metastases
- Albumin ≥ 2.7 g/dL
- Serum creatinine ≤ 1.5 × institutional ULN -OR-
- Creatinine clearance measured creatinine clearance (CrCl) ≥50 mL/min as calculated by either the Cockcroft-Gault method, a 24-hour urine test or another validated test as per local practice (confirmation of creatinine clearance is only required when creatinine is >1.5 x institutional ULN)
- Cockcroft-Gault equation for estimated CrCL:
- CrCl (glomerular filtration rate [GFR]) = (140-age) x (weight/kg) x Fa (72 x serum creatinine mg/dL)
- where F= 0.85 for females and F=1 for males - Participants must have measurable disease by RECIST v. 1.1 criteria and be willing to undergo a pre-treatment and on-treatment tumor biopsy. The biopsy requirement can be waived only with approval from the sponsor-investigator.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patient has read and understands the informed consent form (ICF) and has been given written ICF prior to any study procedures which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Female patients who are not of child-bearing potential* and women of childbearing potential who agree to use adequate contraceptive measures from 2 weeks prior to the study and 5x half-lives of adavosertib + 6 months after study treatment discontinuation, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 7 days prior to the start of study treatment.
- Evidence of non-childbearing status, defined as below:
- -- Women who are surgically sterile (i.e., have undergone bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy).
- -- Age ≥50 years with any one or more of the conditions below:
- Amenorrheic for 12 months or more following cessation of all hormonal replacement therapy
- Had radiation-induced menopause with last menses >1 year ago
- Had chemotherapy-induced menopause with last menses >1 year ago
- Age <50 if amenorrhoeic for 12 months or more following cessation of all hormonal replacement therapy and if luteinizing hormone and follicle-stimulating hormone levels are in the post-menopausal range per institutional standards of practice.
- Male patients should be willing to abstain or use barrier contraception (i.e., condoms) for the duration of the study drug exposure and for 5x half-lives of adavosertib + 3 months after study treatment discontinuation.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
Who cannot join
- Patients who have previously received adavosertib are not eligible.
- Use of an anti-cancer treatment drug ≤ 21 days or 5 half-lives (whichever is shorter) prior to the first dose of adavosertib (AZD1775).
- Any prior palliative radiation must have been completed at least 7 days prior to the first dose of adavosertib, and patient must have recovered from any acute adverse effects, that the treating investigator thinks could impair the tolerance of the study drugs, prior to the start of study treatment.
- Participants who have undergone major surgical procedures ≤ 28 days, or minor surgical procedures ≤ 7 days, of the first dose of adavosertib. No waiting period is required following port-a-cath or other central venous access placement.
- Presence of CTCAE v5.0 Grade >1 toxicity from prior therapy (except alopecia, anorexia or CTCAE grade 2 peripheral neuropathy).
- Patient is unable to swallow oral medications. Note: Patient may not have a percutaneous endoscopic gastrostomy (PEG) tube or be receiving total parenteral nutrition (TPN).
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- Participants with known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases - defined as metastasis having no evidence of progression or hemorrhage for at least 2 weeks after the completion of treatment (including brain radiotherapy). Must be off any systemic corticosteroids for the treatment of brain metastases for at least 14 days prior to enrollment.
- Participants receiving any medications or substances that are known to be moderate to strong inhibitors or inducers of CYP3A4 and which cannot be discontinued at least 2 weeks prior to the first dose of adavosertib are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product. Refer to Protocol Section 5 for information on prohibited concomitant medications.
- Use of herbal medications or supplements within 7 days prior to the first dose of adavosertib.
- History of hypersensitivity to compounds of similar chemical or biologic composition to gemcitabine or adavosertib.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or psychiatric illness/social situations that would limit compliance with study requirements.
- Known HIV-positive participants are ineligible because these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy.
- Participants with a clinically significant gastrointestinal disorder that in the opinion of the treating investigator could impact the absorption of the study drugs, including but not limited to refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of adavosertib.
- Participants with a history of a clinically relevant second primary malignancy within the past 2 years. Exceptions include: resected basal and squamous cell carcinomas of the skin and completely resected carcinoma in situ of any type.
- Pregnant or lactating women are excluded from this study because gemcitabine/adavosertib are anti-cancer 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 gemcitabine/adavosertib, breastfeeding should be discontinued if the mother is treated with gemcitabine/adavosertib.
- Any of the following cardiac diseases currently or within 6 months of the first dose of adavosertib:
- -- Unstable angina pectoris
- -- Acute myocardial infarction
- -- Congestive heart failure ≥ Class 2 (as defined by New York Heart Association (NYHA))
- -- Conduction abnormality not controlled with pacemaker or medication
- Significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible)
- History of Torsades de pointes unless all risk factors that contributed to Torsades have been corrected.
- Participants ECG must not meet the following criteria:
- Resting corrected QTc interval using the Fridericia formula (QTcF) >480 msec (as calculated per institutional standards) (Note: if one ECG performed as screening demonstrates a QTcF > 480 msec, then a mean QTcF of ≤ 480 msec obtained from 3 ECGs 2-5 minutes apart, is required at study entry for the participant to be considered eligible)
- congenital long QT syndrome
About this study
Official title: Phase 2 Single Arm Trial Testing Adavosertib and Gemcitabine in Platinum-Resistant Advanced Pancreatic Adenocarcinoma
This study is being done to test the safety and effectiveness of combining Adavosertib and Gemcitabine in patients with pancreatic cancer.
The names of the study drugs involved in this study are:
- Adavosertib
- Gemcitabine
Read the detailed description
This is an open label, single arm phase 2 trial evaluating adavosertib combined with gemcitabine in platinum-resistant advanced pancreatic cancer.
Laboratory studies suggest that adavosertib and gemcitabine can impair the growth of cancers by interfering with the way cancer cells repair their DNA.
The U.S. Food and Drug Administration (FDA) has not approved adavosertib as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has approved gemcitabine as a treatment option for pancreatic cancer.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
It is expected that about 32 people will take part in this research study.
The Lustgarten Foundation for Pancreatic Research and Stand Up to Cancer are supporting this research study by providing funding to conduct the study. AstraZeneca, a pharmaceutical company, is supplying the study drug, Adavosertib.
- Conditions
- Pancreatic Cancer
- Being tested
- Adavosertib, Gemcitabine
- Keywords
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdavosertibDrug
Also called AZD 1775
Taken Orally
GemcitabineDrug
Also called Gemzar
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| Adavosertib and Gemcitabine | Experimental | Participants will receive:
* Adavosertib 1x per day on days 2, 3, 9, 10, 16, and 17 of every 28 day study cycle.
* Gemcitabineon on days 1,8, and 15 of every 28-day cycle Receives: Drug: Adavosertib; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
The primary objective is the evaluation of the overall response rate (ORR) by RECIST 1.1 criteria.
Objective response rate (ORR) is defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Measured: Baseline and every 8 weeks during treatment until disease progression or unacceptable toxicity up to 2 years
Secondary outcomes (4)
Overall Survival (OS)
Overall Survival (OS) is based on the Kaplan-Meier method and is defined as the time from study entry to death or censored at date last known alive.
Measured: Every 8 weeks during treatment, followed for survival after treatment discontinuation up to 2 years
Progression-free Survival (PFS)
Progression-free Survival (PFS) is based on the Kaplan-Meier method and is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Measured: Every 8 weeks during treatment, followed for survival after treatment discontinuation up to 2 years.
Disease Control Rate (DCR)
Disease Control Rate (DCR) defined as stable disease for ≥16 weeks, confirmed complete response (CR), or confirmed partial response (PR). CR defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
Measured: Baseline and every 8 weeks during treatment until disease progression or unacceptable toxicity up to 2 years
Incidence of Grade 3 or Higher Treatment-Related Toxicity
Evaluation of the safety and tolerability of this combination in platinum-resistant pancreatic cancer patients as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. All grade 3 or higher adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 3 or higher AE of any type during the time of observation.
Measured: Assessed day 1, 2, 3, 8, 9, 10, 15 and 22 at cycle 1, also day 1, 8, 9 and 15 at cycle 2+, and off-treatment up to 2 years. Each cycle is 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study startJun 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: manufacturer choice
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- James Cleary, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Lustgarten Foundation, Stand Up To Cancer
- Responsible party
- Sponsor-investigator, James Cleary, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- James Cleary, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212025
- Sponsor's protocol ID
- 21-620
- Status last verified
- Jun 2022
- First submitted
- 6 Jan 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- 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 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Single Arm Trial Testing Adavosertib and Gemcitabine in Platinum-Resistant Advanced Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05212025
- Acronym / sponsor ID
- 21-620
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: manufacturer choice
- Enrolment
- 0 participants (actual)
- Lead sponsor
- James Cleary, MD, PhDUniversity, hospital or other
- Collaborators
- AstraZeneca, Lustgarten Foundation, Stand Up To Cancer
- Study start
- Jun 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Jan 2022 (actual)
- 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 is being done to test the safety and effectiveness of combining Adavosertib and Gemcitabine in patients with pancreatic cancer.
The names of the study drugs involved in this study are:
- Adavosertib
- Gemcitabine
Detailed description
This is an open label, single arm phase 2 trial evaluating adavosertib combined with gemcitabine in platinum-resistant advanced pancreatic cancer.
Laboratory studies suggest that adavosertib and gemcitabine can impair the growth of cancers by interfering with the way cancer cells repair their DNA.
The U.S. Food and Drug Administration (FDA) has not approved adavosertib as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has approved gemcitabine as a treatment option for pancreatic cancer.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
It is expected that about 32 people will take part in this research study.
The Lustgarten Foundation for Pancreatic Research and Stand Up to Cancer are supporting this research study by providing funding to conduct the study. AstraZeneca, a pharmaceutical company, is supplying the study drug, Adavosertib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adavosertib and Gemcitabine | Experimental | Drug: Adavosertib, Drug: GemcitabineParticipants will receive: * Adavosertib 1x per day on days 2, 3, 9, 10, 16, and 17 of every 28 day study cycle. * Gemcitabineon on days 1,8, and 15 of every 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 (29 listed)
- Participants must have a histologically confirmed advanced pancreatic adenocarcinoma that is not curable with standard approaches based on the judgement of the treating investigator. Patients with metastatic pancreatic cancer and unresectable pancreatic cancer are eligible.
- Patients must have progressed on a platinum-based regimen prior to enrolling on the trial.
- Patients must have received no more than 1 prior lines of platinum-based chemotherapy in the metastatic setting. Therapy given in the adjuvant or neoadjuvant setting is counted as a prior therapy if it occurred less than 6 months before cancer recurrence or progression.
- Age ≥ 18 years. As no dosing or adverse event data are currently available in participants < 18 years of age, children and adolescents are excluded from this study.
- ECOG performance status of 0 or 1 (see Appendix A).
Key exclusion criteria (25 listed)
- -- Unstable angina pectoris
- -- Acute myocardial infarction
- -- Congestive heart failure ≥ Class 2 (as defined by New York Heart Association (NYHA))
- -- Conduction abnormality not controlled with pacemaker or 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 |
|---|---|---|
| AdavosertibAlso: AZD 1775Taken Orally | Drug | Adavosertib and Gemcitabine |
| GemcitabineAlso: GemzarIntravenous Infusion | Drug | Adavosertib and Gemcitabine |
Primary outcome
Overall Response Rate (ORR)
Time frame: Baseline and every 8 weeks during treatment until disease progression or unacceptable toxicity up to 2 years
The primary objective is the evaluation of the overall response rate (ORR) by RECIST 1.1 criteria. Objective response rate (ORR) is defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
4 secondary outcomes
Overall Survival (OS)
Time frame: Every 8 weeks during treatment, followed for survival after treatment discontinuation up to 2 years
Progression-free Survival (PFS)
Time frame: Every 8 weeks during treatment, followed for survival after treatment discontinuation up to 2 years.
Disease Control Rate (DCR)
Time frame: Baseline and every 8 weeks during treatment until disease progression or unacceptable toxicity up to 2 years
Incidence of Grade 3 or Higher Treatment-Related Toxicity
Time frame: Assessed day 1, 2, 3, 8, 9, 10, 15 and 22 at cycle 1, also day 1, 8, 9 and 15 at cycle 2+, and off-treatment up to 2 years. Each cycle is 28 days.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- 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.
James Cleary, MD, PhD principal investigator
Dana-Farber Cancer Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adavosertib and Gemcitabine in people with Pancreatic Cancer, run by James Cleary, MD, PhD.
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 29 inclusion and 25 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: withdrawn, as of the sponsor's last update on 14 Jun 2022. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Overall Response Rate (ORR) (time frame: Baseline and every 8 weeks during treatment until disease progression or unacceptable toxicity up to 2 years). 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 14 Jun 2022.