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Cell Cycle Checkpoint Kinase Inhibitor

Sequential Olaparib + Adavosertib for Cancer

Phase 1

Waitlist Available

Led By Timothy A Yap

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status score of 0-1 (Karnofsky >= 70%)

Germline or somatic mutations in BRCA1 or BRCA2

Must not have

Previous or current MDS/AML or features suggestive of MDS/AML

Concomitant use of strong or moderate CYP3A inducers/inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up tumor reassessment every 8 weeks from start of treatment until radiological documentation of disease progression/recurrence through study completion, for a period of approximately 3 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing adavosertib with olaparib to see if it's effective at treating patients with solid tumors that have spread with selected mutations.

Who is the study for?

This trial is for adults with advanced solid tumors that have spread and are not treatable by surgery or other standard treatments. Participants must have specific genetic mutations, including BRCA1/2, and their cancer must have progressed after previous PARP inhibitor treatment. They should be in good physical condition (ECOG score 0-1), able to undergo a biopsy, and willing to use effective contraception.

What is being tested?

The STAR study is testing the sequential use of two anti-cancer drugs: Olaparib followed by Adavosertib in patients with advanced solid tumors resistant to PARP inhibitors. The goal is to find the safest doses with the least side effects while trying to shrink or stabilize the cancer.

What are the potential side effects?

Possible side effects include fatigue, nausea, vomiting, diarrhea, blood count changes leading to increased infection risk or bleeding problems, liver enzyme changes suggesting liver damage, allergic reactions similar to those seen with compounds like AZD1775 or olaparib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I have a genetic mutation in BRCA1 or BRCA2.

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I have specific gene mutations related to DNA repair or cyclin E amplification.

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My cancer initially responded to treatment but has since gotten worse.

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I have BRCA mutations and my cancer progressed after PARP inhibitor treatment.

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I had treatment with PARP inhibitors, showed improvement but then my cancer progressed. I also have specific genetic mutations or changes.

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My tumor can be measured and biopsied, and I agree to have a biopsy.

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My cancer has spread, cannot be surgically removed, and standard treatments are not effective.

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I've had at least one treatment for my advanced cancer or there are no treatments known to work for me.

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I am using two effective birth control methods or not having sex.

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I am HIV-positive, on treatment, with no recent severe infections and a good immune status.

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My cancer can be measured and biopsied safely, and I agree to have a biopsy.

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My cancer has spread, cannot be surgically removed, and standard treatments are not effective.

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I have been treated with PARP inhibitors before.

Exclusion Criteria

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

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I have or had myelodysplastic syndrome or acute myeloid leukemia.

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I am not taking strong or moderate drugs that affect liver enzymes.

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I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.

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I am allergic to medications similar to AZD1775 or olaparib.

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I am not taking any other cancer treatments while on the study medication.

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I have brain metastases but they are stable and treated.

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I have lasting side effects from cancer treatment, but not hair loss.

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I haven't had serious heart issues like heart attacks or uncontrolled heart rhythm problems in the last 6 months.

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I have not had radiotherapy in the last 28 days.

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I haven't taken any cancer drugs in the last 28 days or 5 half-lives.

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I cannot swallow pills or have a stomach condition that affects medication absorption.

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I have had a bone marrow or cord blood transplant before.

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I will not drink grapefruit juice while taking the study drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ tumor reassessment every 8 weeks from start of treatment until radiological documentation of disease progression/recurrence through study completion, for a period of approximately 3 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~tumor reassessment every 8 weeks from start of treatment until radiological documentation of disease progression/recurrence through study completion, for a period of approximately 3 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and tumor reassessment every 8 weeks from start of treatment until radiological documentation of disease progression/recurrence through study completion, for a period of approximately 3 years. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose Limiting Toxicity

Incidence and Causality of Treatment-Related Adverse Events

Secondary study objectives

Clinical Benefit

Objective Response Rate

Overall Survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (olaparib, adavosertib)Experimental Treatment2 Interventions

Patients receive olaparib PO BID on days 1-5 and 15-19 of each cycle and adavosertib PO QD on days 8-12 and 22-26 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2190

Adavosertib

2015

Completed Phase 2

~570