NCT03334487

Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer

Brief summary

A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer by evaluating the frequency of high grade (>= Grade 3) select treatment-emergent adverse events (TEAEs).

Interventional study

Status:
Withdrawn
Conditions:
Small Cell Lung Cancer
Enrollment:
0 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M16-292
Intervention model:
Single Group Assignment
Masking:
None (Open Label)
Purpose:
Treatment

Would you like to know more about this trial?

alert image Please note, participation in the clinical trial is open to patients with the disease or condition under investigation.
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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Minimum life expectancy of at least 12 weeks.

- Laboratory values meeting the criteria specified in the protocol.

- Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with
documented disease progression after at least 2 prior systemic regimens, including at
least one platinum-based regimen.

- Delta-Like Protein 3 (DLL3)-expressing SCLC based on central immunohistochemistry
(IHC) assessment of banked or otherwise representative tumor tissue.

- Measurable disease as described per protocol.

- In participants with a history of central nervous system (CNS) metastases,
documentation of stable or improved status based on brain imaging for at least 2 weeks
after completion of definitive treatment and within 2 weeks prior to first dose of
study drug, off or on a stable dose of corticosteroids.

Exclusion Criteria:

- Documented history of a cerebral vascular event (stroke or transient ischemic attack),
unstable angina, myocardial infarction, or cardiac symptoms consistent with New York
Heart Association Class III - IV within 6 months prior to first dose of study drug.

- Recent or on-going serious infection.

- History of other invasive malignancy that has not been in remission for at least 3
years.

- History of exposure to a pyrrolobenzodiazepine (PBD)-based drug or known
hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug
formulation.

- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells.

- Documented history of capillary leak syndrome.

- Grade 2 or higher pleural or pericardial effusion within 4 weeks of investigational
drug start, or earlier history of recurrent Grade 2 or higher effusions with ongoing
requirements for pericardiocentesis or thoracentesis.

All the cities where the clinical studies are located

Calgary - T2N 4N2
Halifax - B3H 1V7
London - N6A 5A5
Ottawa - K1H 8L6

Alberta

Nova Scotia