Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205

OSI Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Ependymoma

Treatments: Drug: Erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01247922

OSI-774-206

2010-023478-38 (EudraCT Number)

Details and patient eligibility

About

Participants that were assigned to the oral etoposide treatment arm in protocol OSI-774-205 and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide were allowed to participate in this study to assess the safety profile of single-agent erlotinib in participants with recurrent or refractory pediatric ependymoma.

Full description

The protocol-specified futility criteria were met at the second interim analysis dated 15 Aug 2012 for OSI-774-205. Per the Data Monitoring Committee's recommendation and FDA's agreement, the enrollment of patients in that study and Study OSI-774-206 was permanently closed.

Enrollment: 4 patients

Sex: All

Ages: 1 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have been enrolled in OSI-774-205, been randomized to oral etoposide and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide
• Performance status: Lansky ≥ 50% for patients ≤ 10 years of age or younger or Karnofsky ≥ 50% for patients greater than 10 years of age
• Patients must have recovered from any acute toxicity to any prior anti-cancer treatment
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, serum glutamic pyruvic transaminase (SGPT) ALT ≤ 3 x ULN
• Serum creatinine based on age OR Creatinine Clearance/Glomerular Filtration Rate (GFR) ≥ 70 mL/min/m2
• Patients must be neurologically stable for at least 7 days before registration
• Patients, both males and females, with reproductive potential must agree to practice effective contraceptive measures for the duration of study drug therapy and for at least 90 days after completion of study drug therapy
• Patients must be able to take erlotinib orally

Exclusion criteria

• Taking strong/moderate CYP3A4 or CYP1A2 inhibitors/inducers ≤ 14 days before registration
• Have received any other chemotherapy or immunotherapy to treat ependymoma after discontinuation from OSI-774-205
• Taking proton pump inhibitors ≤ 14 days before registration
• Participating in another investigational drug trial while on study
• Pregnant or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Erlotinib

Experimental group

Description:

Participants who received erlotinib in a continuous oral dose of 85 mg/m\^2 per day until dose modification, interruption or study discontinuation occurred.

Treatment:

Drug: Erlotinib