AMG 102 and Erlotinib for Advanced Non-Small Cell Lung Cancer

NCT01233687 | Completed Phase 1 Results DMC

• 1 other identifier: 10-058
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I/II study of erlotinib and AMG 102 in previously treated subjects with advanced NSCLC. Subjects will be enrolled with recurrent or progressive advanced stage NSCLC that has been treated with at least one and a maximum of two prior chemotherapy regimens. The Phase I part of the study will enroll 8-16 subjects with the Phase II part enrolling 21-45 subjects. The Phase I part of the study is designed to determine how safest the combination of AMG 102 and erlotinib is and the recommended dose for the Phase II part. The Phase II part is to determine whether the combination of AMG102 and erlotinib works enough to warrant further interest in this combination.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Recurrent; progressive; advanced

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants That Experienced a Dose Limiting Toxicity

  Determination of the safety and recommended phase II dose of AMG 102 when combined with erlotinib for the treatment of patients with advanced, previously-treated NSCLC.

  During first cycle of treatment (3 weeks)

• Disease Control Rate (DCR)

  Using RECIST v1.1 criteria, DCR was determined by following equation: the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants / the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.

  Six weeks from initiation of treatment with AMG 102 + Erlotinib

Secondary Outcomes (3)

• Objective Response Rate (ORR/Clinical Response)

  Up to 6 months

• Progression-free Survival (PFS)

  Up to 24 months (after the first patient is accrued)

• Overall Survival (OS)

  Up to 24 months (after the first evaluable patient is accrued)

Study Arms (1)

AMG 102 and erlotinib

EXPERIMENTAL

Combination of AMG 102 and erlotinib

Drug: AMG 102 and erlotinib

Interventions

AMG 102 and erlotinib DRUG

Dose Level -2 Dose level -1 Dose Level 0 AMG 102 5 mg/kg 7.5 mg/kg 15 mg/kg Erlotinib 150 mg 150 mg 150 mg The first cohort of patients in the phase I portion will start at dose level 0 of AMG102.

Also known as: Rilotumumab

AMG 102 and erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with recurrent or progressive advanced stage Non-small cell lung cancer (NSCLC,no SCLC component) who have been treated with at least one and a maximum of two prior chemotherapy regimens for advanced NSCLC. Chemotherapy as part of initial potentially curative therapy (given as part of adjuvant or concomitant chemoradiotherapy) that was completed \<1 year counts as 1 prior regimen. Prior erlotinib, other epidermal growth factor receptor (EGFR) TKIs or monoclonal antibodies targeting EGFR are not allowed.
• NOTE: Chemotherapy as part of initial potentially curative therapy (given as part of adjuvant or concomitant chemoradiotherapy) that was completed one or more years prior to screening for this study does not count as a prior regimen.
• If the tumor is refractory (progressed) after a prior chemotherapy regimen, then that regimen would count. If a prior chemotherapy regimen has been changed due to other reasons than disease progression (e.g. poor tolerance, allergic reaction), then it would not count as a separate prior regimen. A chemotherapy drug added for "maintenance" following disease stabilization or response to a chemotherapy regimen (in the absence of prior disease progression) does not count as a separate prior regimen.
• NOTE: Pathology reports documenting the diagnosis of NSCLC are required to be reviewed by the screening physician investigator.
• Measurable disease (RECIST version 1.1) (for phase II part only).
• Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 and life expectancy of ≥ 3 months.
• NOTE: For the phase I part of the study, patients with ECOG Performance Status 2 will be excluded.
• Age ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
• Patients must meet the following laboratory criteria (within 14 days prior to study registration):
• oHematology: Absolute neutrophil count (ANC) ≥ 1500/mm³ Platelets ≥ 100,000/mm³ Hemoglobin ≥ 9 g/dL International normalized ratio (INR) ≤ 1.5 or prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution oBiochemistry: Total Bilirubin within normal institutional limits. AST/SGOT and ALT/SGPT ≤ 2.5 x upper limit of normal (ULN), except if there is known hepatic metastasis, wherein transaminases may be ≤ 5 x institutional ULN.
• Creatinine clearance 45 ml/min or higher calculated using the Cockcroft-Gault formula. Multiply the number by 0.85 if the patient is female.
• If patient has history of brain metastases, brain lesions should have been treated with surgery and/or radiation and be stable on repeat imaging and patients should be neurologically stable on a stable or tapering dose of corticosteroids.
• No history of prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, unless there is a 3-year disease-free interval.
• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days of the first administration of study treatment and must be willing to use two methods of contraception one of them being a barrier method or abstain from sexual activity during the study and for 6 months after last study drug administration. Sexually active males and their female partners must agree to use two methods of accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study.
• All patients must have given signed, informed consent prior to registration on study.

Sponsors & Collaborators

• Ahmad Tarhini: lead
• Amgen: collaborator

Study Sites (1)

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Recurrence

Interventions

rilotumumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Ahmad Tarhini, MD
• Organization: University of Pittsburgh

tarhiniaa@upmc.edu

(412) 648-6578

Study Officials

• Ahmad Tarhini, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 3, 2010
• Study Start: August 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 22, 2017
• Results First Posted: September 1, 2016

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)