Olaparib for Stage IIB Pancreatic Cancer AJCC v8

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
OHSU Knight Cancer Institute, Portland, OR
Stage IIB Pancreatic Cancer AJCC v8+13 More
Olaparib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called cobimetinib or olaparib might work better than standard treatments for people with pancreatic cancer.

See full description

Eligible Conditions

  • Stage IIB Pancreatic Cancer AJCC v8
  • Stage II Pancreatic Cancer AJCC v8
  • Stage I Pancreatic Cancer AJCC v8
  • Stage IB Pancreatic Cancer AJCC v8
  • Stage IV Pancreatic Cancer AJCC v8
  • Metastatic Pancreatic (Ductal) Adenocarcinoma
  • Resectable Pancreatic Ductal Adenocarcinoma (PDAC)
  • Stage III Pancreatic Cancer AJCC v8
  • Stage IA Pancreatic Cancer AJCC v8
  • Stage IIA Pancreatic Cancer AJCC v8
  • Borderline Resectable Pancreatic Adenocarcinoma
  • Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Stage IIB Pancreatic Cancer AJCC v8

Study Objectives

This trial is evaluating whether Olaparib will improve 2 primary outcomes and 2 secondary outcomes in patients with Stage IIB Pancreatic Cancer AJCC v8. Measurement will happen over the course of Changes in tumor biology from baseline (i.e., Day 0) and on-treatment biopsy (i.e., 10 days from start of study intervention).

Day 10
Proportion of all feasibility-evaluable participants that have a measurable change in post-treatment tumor biology from baseline
Proportion of all pharmacodynamic feasibility-evaluable participants that have a measurable change in post-treatment tumor biology from baseline
Proportion of feasibility-evaluable participants within each study arm that have a measurable change in post-treatment tumor biology from baseline
Up to 30 days
Incidence of >= grade 3 toxicities for each assigned window treatment

Trial Safety

Safety Progress

1 of 3

Other trials for Stage IIB Pancreatic Cancer AJCC v8

Trial Design

4 Treatment Groups

Arm IV (onvansertib)
1 of 4
Arm II (olaparib)
1 of 4
Arm III (temuterkib)
1 of 4
Arm I (cobimetinib)
1 of 4
Experimental Treatment

This trial requires 80 total participants across 4 different treatment groups

This trial involves 4 different treatments. Olaparib is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Arm IV (onvansertib)
Drug
Patients receive onvansertib PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient's disease.
Arm II (olaparib)
Drug
Patients receive olaparib PO BID on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery.
Arm III (temuterkib)
Drug
Patients receive temuterkib PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient's disease.
Arm I (cobimetinib)
Drug
Patients receive cobimetinib PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved
Onvansertib
2017
Completed Phase 2
~80
Cobimetinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 30 days for reporting.

Who is running the study

Principal Investigator
C. D. L.
Charles D Lopez, Principal Investigator
OHSU Knight Cancer Institute

Closest Location

OHSU Knight Cancer Institute - Portland, OR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Stage IIB Pancreatic Cancer AJCC v8 or one of the other 13 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Clinically-confirmed diagnosis of adenocarcinoma of the pancreas (resectable, borderline resectable, locally advanced, or metastatic disease at presentation) are eligible
People in the study may have never been treated before, or they may have received treatment before for their pancreatic cancer show original
The person in the study must have at least one lesion that can be biopsied, in accordance with the institutional standards. show original
The patient must have a hemoglobin level of 10.0 g/dL or higher without receiving a blood transfusion in the 28 days prior to starting treatment (within 4 weeks of starting the window treatment). show original
The patient's blood must have an absolute neutrophil count of at least 1,500 per cubic millimeter within four weeks of starting the treatment window. show original
The text suggests that the policy of not waiving the $50 fee for laboratory tests may be waived on a case-by-case basis for certain patients. show original
Definite platelet count > 100 x 10^9/L (> 100,000 per mm^3) at least 4 weeks before starting the treatment window. show original
The text states that a person's white blood cell count must be above 3x10^9/L four weeks before they start treatment with a window. show original
Ability to understand and the willingness to sign a written informed consent document
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 means that the individual is able to carry out all self-care activities, normal work, and activities of daily living, with minimal assistance. show original

Patient Q&A Section

Can cancer of pancreas be cured?

"Early diagnosis and well-controlled treatment are a prerequisite for a normal life. In some patients, the malignant cells remain in the body but are effectively controlled by the treatment. Patients with the cured disease seem to be free from the disease for the period available in their life. This fact and their good quality of life, may be used to convince the patients to consider palliative care." - Anonymous Online Contributor

Unverified Answer

How many people get cancer of pancreas a year in the United States?

"Findings from a recent study shows that most cases of cancer of pancreas are diagnosed among older people. Also, it demonstrates that cancer of pancreatic duct is the most common cause of cancer of the pancreas." - Anonymous Online Contributor

Unverified Answer

What is cancer of pancreas?

"Cancer of pancreas has the highest number of fatal cases in the country. answer: Cancer of pancreas has very high fatal case count in Nepal. This is due to a high number of chronic diseases and lack of adequate care. Cancer of pancreas is not included in the basic health policy of Nepal. It is a vital problem, as it has significant financial burden, and high rate of death and other health problems. More focus needs to be given to cancer of pancreas." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer of pancreas?

"The common treatments for cancer of pancreas are summarized in this article. Differential use of chemotherapeutic agents was observed in tumors of different histologies. As in other malignancies, chemotherapeutics have been used first line with response rates of 23-65%. Radiation therapy is often used for tumors with advanced lesions and for locoregional control of these metastatic lesions. Chemo-sensitive tumors are often treated with radiation therapy or other chemotherapeutic drugs, with response rates being as high as 50-96%." - Anonymous Online Contributor

Unverified Answer

What causes cancer of pancreas?

"The pancreatic cancer risk associated with CPRA is not affected by any modifier, but the disease in patients with CPRA is significantly related to the age of onset and tumor size." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer of pancreas?

"The signs of pancreatic carcinoma include weight loss, poor appetite, dullness (pale appearance) and malaise (tired) or pain. Decreased jaundice, with no specific abnormalities on physical examination, may suggest the diagnosis. Abdominal mass may indicate a cancer of the pancreas or an acute pancreatitis, and patients should be questioned about a family history of pancreatic cancer. Diagnosis often requires testing procedures such as computed tomography (CT) scan or magnetic resonance imaging (MRI). These procedures have good sensitivity and specificity and are usually performed after a biopsy." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving olaparib?

"There was a significant lack of research involving olaparib. There is little evidence for the benefits of olaparib in specific subgroups with advanced pancreatic cancer. A trial with olaparib is ongoing for women with a HER2 positive and/or PgR negative breast cancer. [Astrofund." - Anonymous Online Contributor

Unverified Answer

Is olaparib safe for people?

"In this phase 2b study comparing carboplatin/bolus liposomal doxorubicin plus olaparib versus carboplatin/bolus liposomal doxorubicin plus doxorubicin in people with metastatic/high risk epithelial ovarian cancer (EOC), the authors identified no significant differences in grade rash/fever, or serious cutaneously related events between the two treatment groups. Neither common side effects of olaparib nor anemia prevented dose escalation. The safety profile of olaparib is not expected to be driven by its interaction with carboplatin/liposomal doxorubicin." - Anonymous Online Contributor

Unverified Answer

Has olaparib proven to be more effective than a placebo?

"Olaparib is a highly effective and well-tolerated chemotherapeutic agent in the treatment of ovarian cancer, and has been shown to be active against platinum refractory and platinum-sensitive recurrent high-grade serous epithelial ovarian cancer. Olaparib is well-tolerated at both standard doses and at both dosing intervals." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing cancer of pancreas?

"Pancreatic cancer is a rare disorder, however, it is related with complications including gallstone, pancreatitis, diabetes, or bleeding. Diabetes, especially type 2 diabetes mellitus, is not strongly correlated but it is related with pancreatitis. Moreover it is correlated with chronic alcohol abuse as well as smoking and also high blood pressure." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating cancer of pancreas?

"We thought that there will be more advancements in research, and more advances in treatment options for patients of pancreatic cancer through more studies. There may also be new research on pancreatic cancer itself, which will help us understand better the mechanisms and the cause of the disease." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cancer of pancreas?

"Although the percentage of metastatic CDA patients with an advanced-stage disease increased, they still had a relatively good prognosis compared to those without cancer invasion in the pancreatic ducts. More intensive efforts are recommended to perform clinical trials for metastatic CDA patients with a good performance status and good life expectancy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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