Know Cancer

or
forgot password

A Phase I Dose-escalation Study of OSI-906 and Erlotinib (Tarceva®) in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

A Phase I Dose-escalation Study of OSI-906 and Erlotinib (Tarceva®) in Patients With Advanced Solid Tumors


The study will open with Schedule 1 (S1), in which OSI-906 is administered on Days 1-3 every
7 days. Erlotinib will be administered daily starting on Day 2. A treatment period is
defined as 21 days.

Initiation of Schedule 2 (S2), in which OSI-906 is administered daily starting on Day 1 and
erlotinib is administered daily starting on Day 2, will occur after observation of
clinically significant related toxicity >/= grade 2 in any patient on S1 or after > 2 dose
levels in S1 have been examined without evidence of Dose Limiting Toxicities (DLT).

Initiation of Schedule 3 (S3), in which OSI-906 is administered twice daily starting on Day
1 and erlotinib is administered daily starting on Day 2, will occur after observation of
clinically significant related toxicity >/= grade 2 in any patient on S2 or after > 2 dose
levels in S2 have been examined without evidence of DLT.

Once the phase 2 dose has been established for S3, 1 expansion cohort will be opened.

The Expansion Cohort will enroll approximately 30 evaluable patients with stage IIIB/IV
Non-small Cell Lung Carcinoma (NSCLC). Patients in the NSCLC Expansion Cohort will be
required to have either archival tissue or fresh tumor tissue available at the start of
study.


Inclusion Criteria:



- Histologically or cytologically confirmed advanced solid tumor

- For the NSCLC Expansion Cohort, a confirmed diagnosis of stage IIIB/IV NSCLC after
failure of at least 1 prior chemotherapy regimen is required

- Patients with Eastern Cooperative Oncology Group (ECOG) performance status
- Predicted life expectancy >/= 12 weeks

- Patients may have had prior therapy, providing certain conditions are met:

1. Chemotherapy: A minimum of 3 weeks (4 weeks for carboplatin or investigational
anticancer agents and 6 weeks for nitrosoureas and mitomycin C) must have
elapsed between the end of treatment and registration into this study. Patients
must have recovered from any treatment-related toxicities (except for alopecia,
fatigue, and grade 1 neurotoxicity) prior to registration.

2. Hormonal therapy: Patients may have had prior anticancer hormonal therapy
provided it is discontinued prior to registration into the study. However,
patients with prostate cancer with evidence of progressive disease may continue
on therapy that produces medical castration (eg, goserelin or leuprorelin),
provided this therapy was commenced at least 3 months earlier.

3. Radiation: Patients may have had prior radiation therapy provided they have
recovered from the acute, toxic effects of radiotherapy prior to registration.
A minimum of 21 days must have elapsed between the end of radiotherapy and
registration into the study unless the radiation affected less than 25% of bone
marrow.

4. Surgery: Previous surgery is permitted provided that wound healing has occurred
prior to registration.

- Fasting glucose
- Blood ketones
- Neutrophil count >/= 1.5 x 10^9/L

- Platelets >/= 100 x 10^9/L

- Bilirubin
- AST and/or ALT metastases

- Serum creatinine
- Patients must be nonsmokers (or former smokers who stopped smoking > 3 months
previously) and have a negative cotinine test at baseline and on Day 1

- Patients in the NSCLC Expansion Cohort must have measurable disease per Response
Evaluation Criteria in Solid Tumors (RECIST)

- Patients in the NSCLC Expansion Cohort will be required to have either an archival or
fresh tumor tissue (whole or partial block) available at the start of study

- Patients must be accessible for repeat dosing and follow-up, including
pharmacokinetic sampling

- Patients - both males and females - with reproductive potential must agree to
practice effective contraceptive measures throughout the study. Women of childbearing
potential must provide a negative pregnancy test at baseline and on Day 1

- Patients must provide verbal and written informed consent to participate in the study

Exclusion Criteria:

- Documented history of diabetes mellitus

- History of significant cardiac disease unless the disease is well-controlled.
Significant cardiac diseases includes second/third degree heart block; significant
ischemic heart disease; QTc interval > 450 msec at baseline; poorly controlled
hypertension; congestive heart failure of New York Heart Association (NYHA) Class II
or worse (slight limitation of physical activity; comfortable at rest, but ordinary
physical activity results in fatigue, palpitation, or dyspnea)

- History of cerebrovascular accident (CVA) within 12 months prior to registration or
that is not stable

- Prior epidermal growth factor receptor (EGFR) or insulin like growth factor receptor
(IGFR) inhibitor therapy, except for prior erlotinib therapy in the NSCLC Expansion
Cohort, prior erlotinib therapy will not be exclusionary

- History of any psychiatric condition that might impair the patient's ability to
understand or to comply with the requirements of the study or to provide informed
consent

- Pregnant or breast-feeding females

- Gastrointestinal (GI) abnormalities including inability to take oral medication,
requirement for intravenous (IV) alimentation, active peptic ulcer, or prior surgical
procedures affecting absorption

- Ocular inflammatory or infectious condition that is not completely resolved prior to
registration

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to the study drug

- Any type of active seizure disorder

- Use of drugs that have a risk of causing QT interval prolongation within 14 days
prior to Day 1 dosing

- Use of strong or moderate CYP3A4 or CYP1A2 inhibitors/inducers, with the exception of
low-dose steroids, within 14 days prior to Day 1 dosing

- Use of proton pump inhibitors within 14 days prior to day 1 dosing

- Symptomatic brain metastases that are not stable, require steroids, or that have
required radiation within the last 28 days

- Active or uncontrolled infections or serious illnesses or medical conditions that
could interfere with the patient's ongoing participation in the study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose (MTD) and recommended phase 2 dose of OSI-906 and erlotinib

Outcome Time Frame:

21 days

Safety Issue:

No

Principal Investigator

Sr. Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Food and Drug Administration

Study ID:

OSI-906-103

NCT ID:

NCT00739453

Start Date:

October 2008

Completion Date:

December 2011

Related Keywords:

  • Advanced Solid Tumors
  • Advanced cancer
  • Non-small cell lung cancer
  • Pancreatic cancer
  • Colorectal cancer
  • Prostate cancer

Name

Location

University of Colorado Health Science CenterAurora, Colorado  80010-0510
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland  21231
Hudson-Webber Cancer Research Center, Karmanos Cancer InstituteDetroit, Michigan  48201