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mTORC1/2 Inhibitor
mTOR/AKT Inhibitors for Endometrial and Ovarian Cancer
Phase 1 & 2
Waitlist Available
Led By Shannon N Westin
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed locally advanced recurrent endometrial adenocarcinoma, high-grade serous ovarian/primary peritoneal/fallopian tube carcinoma, or deleterious BRCA mutant recurrent ovarian/primary peritoneal/fallopian tube cancer with no curative option available
Metastatic triple negative breast cancer, defined as negative for estrogen receptor (ER) and progesterone receptor (PR) (< 10% tumor staining)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months from study treatment
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of two different drug combinations in treating patients with recurrent endometrial, triple negative breast cancer, ovarian, primary peritoneal, or fallopian tube cancer.
Who is the study for?
This trial is for patients with recurrent endometrial, ovarian, peritoneal, fallopian tube cancer or triple negative breast cancer. Participants must have a life expectancy over 4 months and be able to take oral meds. They should agree to use contraception and have specific blood levels within normal ranges. Those with other recent cancers or certain health conditions can't join.Check my eligibility
What is being tested?
The study tests the combination of olaparib with either vistusertib (AZD2014) or capivasertib (AZD5363) on tumor growth in selected cancers. It aims to find the safest doses and observe how well these drug combinations work against recurrent cancers by blocking enzymes that promote cell growth.See study design
What are the potential side effects?
Potential side effects include issues related to organ function due to enzyme inhibition which may affect cell growth processes, digestive disturbances from oral medications, possible blood disorders from altered hematologic parameters, and general discomforts like fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced and cannot be cured with surgery or radiation.
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My breast cancer is triple negative.
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I have had multiple chemotherapy treatments for advanced cancer in the uterus, ovaries, or triple-negative breast.
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My type II diabetes is well-managed.
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I can swallow and tolerate pills.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months from study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months from study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose
Secondary outcome measures
Cmax for Olaparib
Progression-free survival (PFS)
Response duration
+2 moreOther outcome measures
Changes in protein expression
Cmax for AZD2014
Side effects data
From 2021 Phase 1 & 2 trial • 24 Patients • NCT0301035865%
Infusion related reaction
59%
Neutrophil count decreased
41%
Upper respiratory infection
29%
Aspartate aminotransferase increased
29%
Platelet count decreased
24%
Alanine aminotransferase increased
18%
Sinusitis
18%
Urinary tract infection
12%
Tooth infection
6%
Bronchial infection
6%
Acute Coronary Syndrome
6%
Febrile neutropenia
6%
Sepsis
6%
Infections and infestations - Other, specify
6%
Nail infection
6%
Rhinitis infective
6%
Tumor lysis syndrome
6%
Infusion Related Reaction
6%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 and MTD (800 mg Entospletinib Daily)
Phase 1, Dose 1 (400 mg Entospletinib Daily)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm III (olaparib, capivasertib)Experimental Treatment3 Interventions
INTERMITTENT AZD5363 DOSING: Patients receive olaparib PO BID on days 1-28 (on days 5-28 of course 1 and alone on days -3 to -1 of week -1) and capivasertib PO BID for 4 days on and 3 days off (alone on days 1-4 of week 1).
Group II: Arm II (olaparib, vistusertib)Experimental Treatment3 Interventions
INTERMITTENT AZD2014 DOSING: Patients receive olaparib PO BID on days 1-28 (days 3-28 on course 1 and alone on days -5 to -3 of week -1) and vistusertib 4 PO BID for 2 days on and 5 days off (alone on days 1-2 of week 1).
Group III: Arm I (olaparib, vistusertib)Experimental Treatment4 Interventions
CONTINUOUS AZD2014 DOSING: Patients receive olaparib PO BID on days 1-28 (days 5-28 of course 1 and alone on days -3 to -1 of week -1) and vistusertib PO BID on days 1-28 (alone on days 1-4 of week 1).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capivasertib
2021
Completed Phase 1
~130
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,508 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,643 Total Patients Enrolled
Shannon N WestinPrincipal InvestigatorM.D. Anderson Cancer Center
11 Previous Clinical Trials
1,037 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any experimental drugs or additional cancer treatments.You have an unusual heart ultrasound or scan before starting the study.There are no preserved samples from when you were first diagnosed with cancer or when it came back.You are expected to live for more than 4 months.You need to provide samples from when you were first diagnosed or when the cancer came back.I haven't had any other cancers in the last 5 years, except for certain types.I have a history of myelodysplastic syndrome.My cancer is not high-grade serous ovarian or it's endometrial carcinosarcoma without a harmful BRCA mutation.I have uncontrolled symptoms from spinal or brain cancer spread.I needed a blood transfusion in the last 28 days.I have had severe side effects from specific cancer drugs.I have a history of heart or brain blood vessel conditions.I do not have serious heart conditions or uncontrolled low blood pressure.I do not have uncontrolled diabetes, proteinuria, or other specific systemic diseases.My tumor cannot be biopsied due to its location.My cancer is advanced and cannot be cured with surgery or radiation.My breast cancer is triple negative.I have had multiple chemotherapy treatments for advanced cancer in the uterus, ovaries, or triple-negative breast.My disease can be measured and biopsied.My type II diabetes is well-managed.I haven't used any blood cell growth factors in the last 2 weeks.I can swallow and tolerate pills.Your blood and body chemistry tests must show normal results.I have not used specific therapies recently.My cancer recurrence can potentially be cured with surgery or radiation.My ECG shows a QT interval of 470 msec or more, or I have a family history of long QT syndrome.Your disease can be measured or assessed using specific criteria for tumors.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (olaparib, vistusertib)
- Group 2: Arm I (olaparib, vistusertib)
- Group 3: Arm III (olaparib, capivasertib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any precedent investigations into Pharmacological Study?
"Currently, 31 Phase 3 trials of Pharmacological Study are underway; 208 total active clinical studies. While Houston is a hub for such research, there are 12652 locations globally running related medical investigations."
Answered by AI
To what maladies is Pharmacological Study most often employed?
"Pharmacological Study is a commonly prescribed medication for advanced directives, as well as malignant neoplasm of the ovary, primary peritoneal cancer, hallucinations and somatic symptoms."
Answered by AI
Is the enrollment process for this clinical trial open at the moment?
"This research trial is not actively enrolling patients at the moment. It was first advertised on November 11th, 2014 and last updated on November 10th 2022. However, if you are open to participating in other studies dealing with cystadenocarcinoma serous or Pharmacological Study trials, there are currently 5971 and 208 respective opportunities available for recruitment."
Answered by AI
Does this clinical trial represent a novel approach to treatment?
"Since 2005, Pharmacological Study has been extensively explored in clinical trials. The inaugural research effort was conducted by AstraZeneca and included 98 participants. Following this initial study, Phase 1 FDA approval was granted to the medication. Currently, 208 active studies are being administered at 1659 sites across 61 nations around the world."
Answered by AI
What is the cap on patient enrolment for this clinical research?
"Currently, this research study is not recruiting participants. The trial was initially posted on November 11th 2014 and last modified on the 10th of November 2022. For other medical studies, there are 5,971 trials actively enrolling individuals with cystadenocarcinoma serous and 208 Pharmacological Study trails in search for volunteers."
Answered by AI
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