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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)

Must not have

Receiving any other investigational agents or additional anti-cancer agents

Endometrial carcinosarcoma; ovarian cancer with histology other than high-grade serous in the absence of a deleterious BRCA mutation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months from study treatment

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any experimental drugs or additional cancer treatments.

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My cancer is not high-grade serous ovarian or it's endometrial carcinosarcoma without a harmful BRCA mutation.

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I have a history of myelodysplastic syndrome.

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I have uncontrolled symptoms from spinal or brain cancer spread.

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I have had severe side effects from specific cancer drugs.

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I have a history of heart or brain blood vessel conditions.

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I do not have serious heart conditions or uncontrolled low blood pressure.

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My tumor cannot be biopsied due to its location.

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I have not used specific therapies recently.

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My cancer recurrence can potentially be cured with surgery or radiation.

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My ECG shows a QT interval of 470 msec or more, or I have a family history of long QT syndrome.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months from study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose

Secondary study objectives

Cmax for Olaparib

Progression-free survival (PFS)

Response duration

+2 more

Other study objectives

Changes in protein expression

Cmax for AZD2014

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358

33%

Infusion Related Reaction

33%

Alanine aminotransferase increased

33%

Aspartate aminotransferase increased

33%

Neutrophil count decreased

17%

Sinusitis

17%

Tumor Lysis Syndrome

17%

Interoperative Hemorrhage

17%

Platelet count decreased

17%

Febrile neutropenia

17%

Infusion related reaction

17%

Upper respiratory infection

17%

Otitis externa

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1, Dose 1 (400 mg Entospletinib Daily)

Phase 2 and MTD (800 mg Entospletinib Daily)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Olaparib

2007

Completed Phase 4

~2190

Capivasertib

2021

Completed Phase 1

~130