Study of Oral OSI-027 in Patients With Advanced Solid Tumors or Lymphoma | Completed
Study of Oral OSI-027 in Patients W... | Completed
Study of Oral OSI-027 in Patients With Advanced Solid Tumors or Lymphoma

Trial Source

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Medical Conditions
  • Any Solid Tumor or Lymphoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT00698243
Primary Trial ID Number

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
The primary objective of this study is to determine the maximum tolerated dose (MTD) and to establish the recommended phase 2 dose of oral OSI-027 when administered via 3 schedules, namely, intermittent, weekly, and continuous in patients with advanced solid tumors or lymphoma, namely, intermittent, weekly, and continuous.
Research Details
  • The study will open with Schedule 1 (S1, intermittent) with initiation of Schedule 2 (S2, weekly) and Schedule 3 (S3, continuous), which may occur in parallel after observation of clinically significant related dose limiting toxicity (DLT) in the S1 schedule. Dosing will be initiated on Day 1 with intermittent weekly dosing continuing for 21 days (1 Treatment Period). Expansion of Dose Escalation Cohorts may occur for S1 and S2 at the recommended phase 2 dose level(s) and a Biomarker Expansion Cohort may be opened in S1 and/or S2.
Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : OSI-027

Study Arm Groups : Schedule 1, Schedule 2, Schedule 3

Intervention Type
See Interventions above
Primary Outcome Measures
    Maximum tolerated dose; 21 days
Secondary Outcome Measures
    Safety profile of OSI-027; up to 5 years; Pharmacokinetic profile of OSI-027; up to 23 days; Preliminary pharmacodynamic relationship with OSI-027 systemic exposure; up to 23 days; Preliminary antitumor activity of OSI-027; up to 5 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    - Histologically or cytologically documented malignancy (solid tumor or lymphoma)

    - Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2

    - Predicted life expectancy of at least 3 months

    - Adequate hematopoietic and hepatic function, and normal renal function

    - Fasting glucose <7mmol/L at baseline

    - Left ventricular ejection fracture (LVEF) by Multiple gated acquisition scan (MUGA)≥ 60%

    - Practice effective contraceptive measures throughout study

    - Verbal and written informed consent

    - Prior therapy:

    - Chemotherapy, minimum of 3 weeks and recovered from any treatment-related toxicities (except for alopecia, and grade 1 neurotoxicity) prior to registration

    - Hormonal, discontinued prior to registration

    - Radiation, minimum of 21 days and recovered from toxic effects prior to registration

    - Surgery, provided wound healing has occurred

    Exclusion Criteria:

    - History of significant cardiac disease unless well controlled

    - Discontinuation from prior therapy due to cardiac toxicity

    - Active or uncontrolled infections

    - Serious illness or medical condition that could interfere with study participation

    - History of any psychiatric condition that might impair understanding or compliance

    - Documented history of diabetes mellitus

    - Pregnant or breastfeeding females

    - Unstable symptomatic brain metastases, that require steroid or that have required radiation in the last 28 days

    - Chronic systemic steroid use for cancer related condition

    - History of allergic reactions

    - Patients with cataract who are expected to undergo surgery within 6 months of registration

    - Use of drugs causing QT interval prolongation within 14 days prior to dosing

    - Patients with clinically significant electrolyte imbalances
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Royal Marsden - Surrey
Sutton
England
SM2 5PT
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Belgium, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase 1 Dose-escalation Study of Intermittent, Once Weekly, and Continuous Daily Oral OSI-027 Dosing in Patients With Advanced Solid Tumors or Lymphoma
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
OSI-027-101
Sponsor(s)
Astellas Pharma Inc
Key Dates

Recruitment Start Date

Jun 2008

Recruitment End Date

Feb 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

13 Jun 2008

Last Updated

11 Apr 2013