Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.

October 4, 2021 updated by: Celgene

A Phase 1a/1b, Multicenter, Open Label, Dosefinding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Dual Dna-pk and Tor Kinase Inhibitor, Cc-115, Administered Orally to Subjects With Advanced Solid Tumors and Hematologic Malignancies

The main purpose of this first human study with CC-115 is to assess the safety and action of a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor types for later-stage clinical trials. The bioavailability of tablet and capsule formulations under fasting and fed conditions will also be evaluated in some patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Latest amendment clarifies that Chronic Lymophocytic Leukemia (CLL) includes T-cell Prolymphocytic Leukemia (T-PLL). Prior treatment with some drugs targeting mTOR, P13K and related pathways is now permitted.

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Villejuif Cedex, France, 94805
        • Gustave Roussy
  • Germany
      • Koeln, Germany, 50937
        • Uniklinik Köln
      • Würzburg, Germany, 97070
        • Universitätsklinikum Würzburg
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Val d'Hebron
      • Madrid, Spain, 28050
        • Hospital Universitario Madrid Sanchinarro
      • San Sebastián (Guipuzcoa), Spain, 20014
        • Hospital de Donosti
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90095
        • UCLA
      • San Francisco, California, United States, 94115
        • University of California, San Francisco Comprehensive Cancer Center and Cancer Research Institiute
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Medical Center - New Center One
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute Drug Development Unit
    • Texas
      • Dallas, Texas, United States, 75201
        • Mary Crowley Medical Research Center
      • Houston, Texas, United States, 77303
        • The University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically-confirmed advanced solid tumor, chronic lymphocytic leukemia, small lymphocytic lymphoma, T-cell prolymphocytic leukemia, Non-Hodgkin Lymphoma or multiple myeloma
  • Progressed or not tolerated standard therapy, and no further standard therapy is available
  • Archival and screening tumor biopsy
  • Eastern Cooperative Oncology Group Performance Status: 0 or 1
  • Adequate organ function

Exclusion Criteria:

  • Prior cancer-directed modalities or investigational drugs within 4 wks or 5 half lives, whichever is shorter
  • Symptomatic brain metastases (prior treatment and stable metastases are allowed)
  • Acute or chronic renal disease or pancreatitis
  • Diarrhea ≥ Grade 2, impaired gastrointestinal absorption
  • Impaired cardiac function
  • History of diabetes requiring treatment, glucose >126 mg/dL, Glycated hemoglobin (HbA1c) ≥6.5%
  • Peripheral neuropathy ≥ Grade 2
  • Known Human Immunodeficiency Virus (HIV) infection, chronic hepatitis B or C (unless associated with hepatocellular cancer)
  • Pregnant, inadequate contraception, breast feeding
  • Most concurrent second malignancies
  • Part B only: Prior treatment with agents targeting both mammalian target of rapamycin (mTOR) complexes (dual mammalian target of rapamycin complex 1/2 inhibitors) and/or PI3K/AKT pathways. However, prior treatment with isolated target of rapamycin complex 1 (TORC1) inhibitors (eg., rapalogs) is allowed in both parts of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CC-115
Drug: CC-115

Part A (actively recruiting): Dose level starts with 0.5mg daily by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose schedule is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity).

Part B: Optimal dose schedule is administered in 28-day cycles until disease progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-Limiting Toxicity
Time Frame: Continuously for 28 days after starting treatment
Continuously for 28 days after starting treatment
Non-Tolerated Dose
Time Frame: Continuously for 28 days after starting treatment
Continuously for 28 days after starting treatment
Maximum Tolerated Dose
Time Frame: Continuously for 28 days after starting treatment
Continuously for 28 days after starting treatment
Maximum Observed Concentration in Plasma of CC-115
Time Frame: Days 1, 2, 15, 16 of treatment
Days 1, 2, 15, 16 of treatment
Area Under the Concentration-Time Curve for CC-115
Time Frame: Days 1, 2, 15 and 16 of treatment
Days 1, 2, 15 and 16 of treatment
Time to Maximum Concentration of CC-115
Time Frame: Days 1, 2, 15, and 16 of treatment
Days 1, 2, 15, and 16 of treatment
Terminal Half-Life for CC-115
Time Frame: Days 1, 2, 15, and 16 of treatment
Days 1, 2, 15, and 16 of treatment
Apparent Total Body Clearance of CC-115
Time Frame: Days 1, 2, 15 and 16 of treatment
Days 1, 2, 15 and 16 of treatment
Apparent Volume of Distribution of CC-115
Time Frame: Days 1, 2, 15, and 16 of treatment
Days 1, 2, 15, and 16 of treatment
Accumulation Index of CC-115
Time Frame: Days 1, 2, 15 and 16 of treatment
Days 1, 2, 15 and 16 of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacodynamics
Time Frame: Screening (within 28 days prior to first dose of study drug) and Days 1, 2, 8, 15, 22, 28, 155, and end of treatment
Phosphorylation inhibition determined by changes in the levels of multiple biomarkers including S6 and, 4EBP (for mTORC1), AKT (for mTORC2) and other appropriate biomarkers in circulating granulocytes and tumor tissue (when available).
Screening (within 28 days prior to first dose of study drug) and Days 1, 2, 8, 15, 22, 28, 155, and end of treatment
Anti-Tumor Efficacy
Time Frame: Every 2-3 months until proof of tumor progression
Tumor response rates using appropriate objective criteria for various malignancies
Every 2-3 months until proof of tumor progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 25, 2011

Primary Completion (ACTUAL)

March 12, 2021

Study Completion (ACTUAL)

March 12, 2021

Study Registration Dates

First Submitted

May 12, 2011

First Submitted That Met QC Criteria

May 12, 2011

First Posted (ESTIMATE)

May 13, 2011

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-115-ST-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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