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New treatment option for Advanced Refractory Solid Tumors
Official title Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START)
ClinicalTrials.gov ID: NCT05035745
What this study is testing
What is Talazoparib?
Talazoparib is an investigational medicine, given as an once-weekly, being studied as a potential treatment for advanced refractory solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- All patients must sign an informed consent in accordance with local institutional guidelines.
- All patient must not have received prior PARPi including talazoparib
- All patients must not have prior therapy with selinexor.
- Age ≥ 18
- Estimated life expectancy of at least 12 weeks.
You likely can't join if
- are met. Hormone ablation therapy is considered an anti-cancer regimen. Radiation and surgery are not considered anti-cancer regimens.
- Measurable disease by RECIST 1.1 criteria.
- Eastern cooperative Oncology Group (ECOG) Performance Status of 0-1
- Adequate bone marrow function and organ function within 2 weeks of study treatment
- Adequate hematologic function defined as:
- Absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 109/L
See the full eligibility criteria
- All patients must sign an informed consent in accordance with local institutional guidelines.
- All patient must not have received prior PARPi including talazoparib
- All patients must not have prior therapy with selinexor.
- Age ≥ 18
- Estimated life expectancy of at least 12 weeks.
- Has recovered from acute toxicities from prior anti-cancer therapies to grade 2 or lower.
- a) Dose escalation phase: Patients with histologically or cytologically confirmed advanced or metastatic solid tumors who have radiological evidence of progressive disease on study entry that is deemed unlikely to...
- are met. Hormone ablation therapy is considered an anti-cancer regimen. Radiation and surgery are not considered anti-cancer regimens.
- Measurable disease by RECIST 1.1 criteria.
- Eastern cooperative Oncology Group (ECOG) Performance Status of 0-1
- Adequate bone marrow function and organ function within 2 weeks of study treatment
- Adequate hematologic function defined as:
- Absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 109/L
- Platelets ≥ 125 x 109/L during dose escalation phase; platelets ≥ 100 x 109/L during dose expansion phase
- Hemoglobin ≥ 9 x 109/L
- Hepatic function:
- Bilirubin ≤ 1.5 times the upper limit of normal (ULN)
- ALT or AST ≤ 2.5 times ULN (or ≤ 5 times ULN with liver metastases)
- Adequate renal function:
- Calculated creatinine clearance of ≥ 60 mL/min, calculated using the formula of Cockroft and Gault: (140-Age) x Mass (kg)/(72 x creatinine mg/dL); multiply by 0.85 if female.
- Able to swallow tablets/ pills.
- Able to comply with study-related procedures.
- Female patients of childbearing potential must have a negative serum pregnancy test at screening and agree to use highly effective methods of contraception throughout the study and for 7 months following the last dose...
- Treatment within the last 30 days with any investigational drug.
- Concurrent administration of any other tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy
- Major surgery within 28 days of study drug administration
- Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
- Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Pregnancy
- Breast feeding
- Poorly controlled diabetes mellitus
- Second primary malignancy that is clinically detectable at the time of consideration for study enrolment (for phase II only).
- Symptomatic brain metastasis.
- History of significant neurological or mental disorder, including seizures or dementia.
- Unable to comply with study procedures
- Current or anticipated use of strong P-gp inhibitors: amiodarone, carvedilol, clarithromycin, cobicistat, darunavir, dronedarone, erythromycin, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone...
- Current or anticipated use of strong BCRP inhibitors: curcumin, cyclosporine A, eltrombopag, elacridar, fumitremorgin C, novobiocin, sulfasalazine
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.