Notch Inhibitor in Advanced Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01158404
First received: July 6, 2010
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

The objective of this phase 1 study is to evaluate the safety and tolerability of Notch Inhibitor in patients with advanced cancer. This study includes dose escalation and dose confirmation components.


Condition Intervention Phase
Advanced Cancer
Drug: Notch Inhibitor
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of a Notch Inhibitor in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • The number of participants with clinically significant effects. [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recommended dose range for phase 2 studies. [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]
  • Document the antitumor activity [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
  • Pharmacokinetics, area under the concentration-time curve [ Time Frame: Cycles 1 and 2 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, maximum concentration(Cmax) [ Time Frame: Cycles 1 and 2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: July 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Notch Inhibitor Drug: Notch Inhibitor

Dose Escalation: 2-120 mg administered orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28 day cycle.

Dose Confirmation: Dose determined by dose escalation administered orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28 day cycle.

Patients experiencing clinical benefit may continue treatment unless discontinuation criteria are met.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have ceased to provide clinical benefit for their disease.
  • The patient must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced and/or metastatic.
  • Have adequate organ function including:

    • Hematologic: Absolute neutrophil count (ANC) ≥1.5 x 109/L, platelets ≥100 x 109/L, and hemoglobin ≥8 g/dL.
    • Hepatic: Bilirubin ≤1.5 times upper limits of normal (ULN) and alanine aminotransferase (ALT) ≤3.0 times ULN.
    • Renal: Serum creatinine ≤1.5 times ULN.
  • Have a performance status less than or equal to 1 for Dose Escalation and less than or equal to 2 for Dose Confirmation on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (treatment-related toxicity resolved to baseline) except for residual alopecia.
  • Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug.
  • Females with childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of study drug.

Exclusion Criteria:

  • Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.
  • Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, inflammatory bowel disease or history of major surgical resection involving the stomach or small bowel).
  • Have malabsorptive syndromes, enteropathies, gastroenteritis (acute or chronic), or diarrhea (acute or chronic).
  • Females who are pregnant or lactating.
  • Have CNS malignancy or metastasis.
  • Have an acute leukemia.
  • Have active bacterial, fungal and/or known viral infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158404

Locations
United States, Oklahoma
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT -5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01158404     History of Changes
Other Study ID Numbers: 13284, I3F-MC-JSRB
Study First Received: July 6, 2010
Last Updated: August 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Metastatic Cancer
Solid Tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 22, 2014