Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START)

Recruiting Phase 1 Phase 2 Interventional Study
Advanced Refractory Solid Tumors Advanced Triple Negative Breast Cancers Metastatic Triple Negative Breast Cancers
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 99
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
63 (estimated)
Sponsor
National University Hospital, Singapore · Other
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About This Trial

This is a single arm, open-label, phase I dose finding study, followed by a phase II expansion study. Phase I will be carried out in a modified 3+3 dose escalation design, with a projected enrolment of 33 patients with refractory solid tumors to determine the RP2D. In the phase II portion, a total of 30 patients with advanced/metastatic TNBC will be enrolled.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. All patients must sign an informed consent in accordance with local institutional guidelines. 2. All patient must not have received prior PARPi including talazoparib 3. All patients must not have prior therapy with selinexor. 4. Age ≥ 18 5. Estimated life expectancy of at lea…
Contacts

Soo Chin Lee

6779 5555

soo_chin_lee@nuhs.edu.sg

CONTACT