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Saruparib in HRDsig+ Solid Tumors

ConditionMalignant Neoplastic Disease (Disorder)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine

About this trial

The main purpose of this study is to study the effect of saruparib, an experimental PARP inhibitor, on tumors that have an Homologous Recombination Deficiency Signature (HRDsig) positive tumor by the investigational FoundationOne®CDx clinical trial assay.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology (ECOG) performance status of 0 to 1

Diagnosis of a metastatic or locally advanced solid tumor malignancy for which no cure is considered possible.

Patients with breast, ovarian, prostate or pancreatic cancer may not enroll within Cohort A

Patients with ovarian cancer may not enroll in Cohort B

Disqualifiers

Reversion variant in the peripheral blood as assessed by a CLIA certified local assay (Cohort A only)

Prior exposure to PARP inhibition

Evidence of platinum-resistance, defined as disease progression within six months of exposure to a platinum chemotherapy (ie cisplatin, oxaliplatin, carboplatin)

Clinical evidence of uncontrolled malabsorption and/or any other gastrointestinal disorder or defect that would in the opinion of the investigator, interfere with absorption of saruparib

Trial design

Design model

Single group

Treatments tested in this trial

  • Saruparib

    Drug

    Saruparib (AZD5305) 60mg PO daily

  • FoundationOne®CDx

    Diagnostic test

    Tumors will be tested for positive HRDsig tumor by the investigational FoundationOne®CDx clinical trial assay.

Treatment groups

124 Participants
are divided into 1 treatment group
Group A: Saruparib (AZD5305)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Best objective response as determined by RECIST v.1.1

Best objective response as assessed by the Investigator per RECIST 1.1

Time frame
From baseline through documented disease progression (RECIST v1.1) or death from any cause, whichever occurs first, up to 2 years.

Secondary outcomes

1

Progression-free survival (PFS)

PFS, as assessed by the Investigator per RECIST 1.1

Time frame
From first dose of saruparib until documented disease progression (RECIST v1.1) or death from any cause, whichever occurs first, up to 2 years.
2

Overall survival

Overall survival, as assessed by the Investigator per RECIST 1.1

Time frame
From first dose of saruparib until death from any cause, up to 2 years.
3

Duration of response (DOR)

DOR as assessed by the Investigator

Time frame
From first documented complete or partial response until disease progression or death, up to 2 years.
4

Disease control rate (DCR)

DCR is defined as the proportion of patients who achieve CR, PR, or SD by RECIST v1.1.

Time frame
Percentage of participants achieving complete response, partial response, or stable disease per RECIST v1.1, assessed up to 2 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abramson Cancer Center at Penn Medicine

Lead sponsor

AstraZeneca

Collaborator

Basser Center for BRCA

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: