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Compares treatment options for Pancreatic Acinar Cell Carcinoma
Official title APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
ClinicalTrials.gov ID: NCT04858334
What this study is testing
What is Olaparib?
Olaparib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for pancreatic acinar cell carcinoma.
Also referred to as AZD 2281, AZD-2281.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial investigates how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed (resected) and has a pathogenic mutation in BRCA1, BRCA2, or PALB2. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- STEP 0 (PRE-REGISTRATION) Patient must be \>= 18 years of age on day of consent
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Patient must have a diagnosis of pancreatic cancer and have successfully undergone a curative intent surgical resection and must have no evidence of...
- NOTE: This includes patients with adenocarcinoma, acinar carcinoma, squamous cell carcinoma adenosquamous and variants thereof. Patients with...
- Patient must (1) be planning to receive, (2) be receiving or (3) have received at least three combined months (i.e., 12 weeks) of perioperative...
See the full eligibility criteria
Who can join
- STEP 0 (PRE-REGISTRATION) Patient must be \>= 18 years of age on day of consent
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Patient must have a diagnosis of pancreatic cancer and have successfully undergone a curative intent surgical resection and must have no evidence of recurrent disease as determined by the investigator
- NOTE: This includes patients with adenocarcinoma, acinar carcinoma, squamous cell carcinoma adenosquamous and variants thereof. Patients with neuroendocrine tumors are excluded from enrolling
- Patient must (1) be planning to receive, (2) be receiving or (3) have received at least three combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent...
- Patient must be no more than 12 weeks from their most recent treatment (this may be chemotherapy, radiotherapy or surgery)
- Patient must have a known pathogenic or likely pathogenic germline or somatic mutation in BRCA1, BRCA2, or PALB2, as determined by a Clinical Laboratory Improvement Amendments (CLIA) certified or equivalently-accredited...
- STEP 1 (RANDOMIZATION) Patient must have met the eligibility criteria outlined above
- Patient must have undergone at least 3 combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy. Patients may have had up to 6 months of...
- Central expert reviewer must have determined the patient eligible for randomization after review of local genetic testing reports
- If mutation in BRCA1, BRCA2 or PALB2 was identified in tumor tissue and the patient has not previously undergone germline testing, the patient must agree to undergo germline testing
- Patient must have no evidence of recurrent or metastatic pancreatic cancer at the time of randomization as documented by baseline scans obtained =\< 4 weeks prior to Step 1 randomization
- Patient must not have previously had evidence of progressive pancreatic cancer while receiving platinum-based therapy
- Patient must be \>= 21 days (three weeks) from their last treatment (including chemotherapy radiotherapy or surgery) but =\< 84 days (twelve weeks) from their last treatment at the time of Step 1 randomization. Patients...
- Patient must have recovered from any adverse events due to prior anti-cancer therapy (i.e., have no residual toxicities \> grade 1 with the exception of alopecia and/or neuropathy)
- Patient must not be receiving any other investigational agents at the time of Step 1 randomization and while on protocol treatment
- Patient must not have any history of allergic reactions attributed to compounds of similar chemical or biological composition to olaparib
- Patient must not have any personal history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML
- Patient must not have any uncontrolled gastrointestinal disorder that would, in the opinion of the investigator, interfere with the ingestion or absorption of olaparib
- Patient must not be pregnant or breast-feeding due the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing...
- Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 6...
- Leukocytes \>= 3,000/mcL (obtained =\< 28 days prior to Step 1 randomization)
- Absolute neutrophil count \>= 1,500/mcL (obtained =\< 28 days prior to Step 1 randomization)
- Platelets \>= 100,000/mcL (obtained =\< 28 days prior to Step 1 randomization)
- Hemoglobin \>= 9.0 g/dL with no blood transfusion in the past 28 days (obtained =\< 28 days prior to Step 1 randomization)
- Total bilirubin =\< 1.5 institutional upper limit of normal (ULN) except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin =\< 2.5 x ULN of the direct bilirubin...
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 2.5 x institutional ULN (obtained =\< 28 days prior to...
- Creatinine =\ 50 mL/min/1.73 m\^2 (obtained =\< 28 days prior to Step 1 randomization)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patient must not have resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia...
- Concomitant use of known potent CYP3A4/5 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir is prohibited
- Patients who are being actively treated for an ongoing concurrent malignancy are ineligible, with the exception of those receiving adjuvant hormone therapies and those receiving topical therapies for skin cancers
- Patient must not have, in the opinion of the investigator, any other concurrent medical condition that would prevent the patient from complying with the study procedures
- Patient must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to...
- Patient must have the ability to understand and the willingness to sign a written informed consent document, or have legally authorized representative provide authorization to participate
- Patient must not have had major surgery within 2 weeks prior to Step 1 randomization and patients must have recovered from any effects of any major surgery
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Kingman, Arizona, United States
- Phoenix, Arizona, United States
- Fort Smith, Arkansas, United States
- Hot Springs, Arkansas, United States
- Jonesboro, Arkansas, United States
- Arroyo Grande, California, United States
- Berkeley, California, United States
- Burbank, California, United States
- Fremont, California, United States
- Modesto, California, United States
- Mountain View, California, United States
- Orange, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- San Luis Obispo, California, United States
- San Mateo, California, United States
- Santa Cruz, California, United States
+ 290 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Kingman, Arizona, United States; Phoenix, Arizona, United States; Fort Smith, Arkansas, United States; Hot Springs, Arkansas, United States and 304 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.