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JOURNAL ONKOLOGIE – STUDIE

Study in Patients With SCLC of Veliparib in Combination With Topotecan

Rekrutierend

NCT-Nummer:
NCT03227016

Studienbeginn:
Oktober 2016

Letztes Update:
27.01.2021

Wirkstoff:
Topotecan, Veliparib

Indikation (Clinical Trials):
Lung Neoplasms, Small Cell Lung Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Central European Society for Anticancer Drug Research

Collaborator:
-

Studienleiter

Joachim von Pawel, MD
Study Chair
Askelios Klinik München Gauting

Kontakt

Studienlocations
(1 von 1)

Studien-Informationen

Detailed Description:

For this study sensitive or refractory SCLC patients (refractory to prior chemotherapy

defined as having experienced no response or a relapse within 90 days after the end of

chemotherapy) will be eligible. In total, around 130 patients will be enrolled, around 30

evaluable patients in phase I and 100 patients in phase II.

The study will consist of two parts:

A preceding Phase I part will be performed to identify the Recommended Dose of veliparib to

be administered in the Phase II part in combination with topotecan at the dose regimen of

1.25 mg/m2 (on days 1-5 of a 3 week cycle [d1-5q21d]). Each patient will be subjected to an

initial cycle of topotecan monotherapy (1.25 mg/m2 on day 1-5 of a 3 week cycle); this run-in

cycle shall prove topotecan tolerance of the candidates. Only patients who do not reveal any

DLTs receive further treatment with combination therapy. In a dose-escalating 3+3 design the

RD of veliparib for the subsequent Phase II part of the study will be defined during a

maximum of 5 cycles combination therapy.

The Phase II part will follow upon completion of Phase I.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Subject must be ≥ 18 years of age

- Subject with progressive or recurrent ED-SCLC after first line platinum-based therapy,

which is either histologically or cytologically confirmed

- Performance status (PS) 0-2 ECOG

- Adequate bone marrow reserve

- Total bilirubin < 2 x upper limit of normal

- AST and ALT < 2.5 x upper limit of normal, or < 5 x upper limit of normal in case of

liver metastases

- Serum creatinine < 2 x upper limit of normal or creatinine clearance > 50 ml/min

Exclusion Criteria:

- Other anti-cancer chemotherapy or radiotherapy

- Symptomatic motor or sensory neuro-toxicities CTCAE > Grade 2 or any other unresolved

toxicities from prior systemic anti-cancer therapy or radiotherapy CTCAE > Grade 1

- Known hypersensitivity to topotecan or veliparib

- Brain or meningeal metastasis (unless they are asymptomatic and not requiring systemic

corticosteroid therapy)

- Major surgery within 6 weeks prior to first treatment on study (subjects must have

completely recovered from any previous surgery prior to first treatment on study).

- History of cardiac events within the past 3 months

- Uncontrolled severe hypertension

- Abdominal or tracheo-oesophageal fistula, gastrointestinal perforation, or

intra-abdominal abscess

- Uncontrolled nausea / vomiting / diarrhea

- Previous malignancy (other than SCLC) in the last 3 years, except basal cell cancer of

the skin, pre-invasive cancer of the cervix, T1a prostate carcinoma or superficial

bladder tumor [Ta, Tis and T1] that was cured in the opinion of the investigator.

- History of organ allograft

- Active (acute or chronic) or uncontrolled infection of bacterial, mycotic or viral

genesis

Studien-Rationale

Primary outcome:

1. adverse events (Time Frame - 6 months):
adverse events related to study drug(s) qualifying as Dose-Limiting Toxicities (DLT)

Geprüfte Regime

  • veliparib (PARP inhibitor):
    Topotecan at increasing doses (1x or 2x per day) will be administered in each cycle.
  • Topotecan (Hycamtin):
    Topotecan at dose 1.25 mg/m2 will be administered in each cycle.

Quelle: ClinicalTrials.gov


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