A Phase I Clinical Study of Oral CP-4126 in Patients With Advanced Solid Tumour

This study has been completed.
Sponsor:
Information provided by:
Clavis Pharma
ClinicalTrials.gov Identifier:
NCT00778128
First received: October 22, 2008
Last updated: September 3, 2010
Last verified: September 2010
  Purpose

At step 1, patients with advanced solid tumors will receive CP-4126 capsules following a dose escalation schedule until the maximum tolerated dose is reached. At step 2, 20 patients will be randomized. They will receive at days 1 and 8 in a double cross design either oral CP-4126 at the recommended dose or gemcitabine 1000mg/m2 intravenously. At both steps, the schedule of treatment will be day 1, 8, 15 q4w until complete response or disease worsening/ progressing. All further treatment at step 2 will be oral CP-4126.


Condition Intervention Phase
Solid Tumors
Drug: CP-4126
Drug: Gemcitabine
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: A Phase I Clinical Study of Oral CP-4126 in Patients With Advanced Solid Tumour

Resource links provided by NLM:


Further study details as provided by Clavis Pharma:

Primary Outcome Measures:
  • Step 1: MTD of oral CP-4126 in patients with advanced solid tumours, followed by establishing the recommended dose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Step 2: Pharmacokinetic parameters comparison of oral CP-4126 with IV gemcitabine [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability of oral CP-4126 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Biovailability of oral CP-4126 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Preliminary assessment of antitumor activity of oral CP-4126 [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: October 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

Step 1: Dose escalation - oral CP-4126

Step 2: Oral CP-4126 on day 1 and 15 in a 4 week schedule. One dose (only) gemcitabine IV on day 8.

Drug: CP-4126
Step 1: Dose escalation oral CP-4126 until maximum tolerated dose. Step 2: Oral CP-4126 day 1 and 15 + IV Gemcitabine 1000 mg/m2 day 8 in a 4 week schedule until complete response or disease worsening / progression
Other Name: CP-4126
Drug: Gemcitabine
Step 1: Dose escalation oral CP-4126 until maximum tolerated dose Step 2: Oral CP-4126 day 8 and 15 + IV Gemcitabine 1000 mg/m2 day 1 in a 4 week schedule until complete response or disease worsening / progression
Other Name: Gemcitabine
Experimental: 2

Step 1: Dose escalation - oral CP-4126

Step 2: Oral CP-4126 on day 8 and 15 in a 4 week schedule. One dose (only) gemcitabine IV on day 1.

Drug: CP-4126
Step 1: Dose escalation oral CP-4126 until maximum tolerated dose. Step 2: Oral CP-4126 day 1 and 15 + IV Gemcitabine 1000 mg/m2 day 8 in a 4 week schedule until complete response or disease worsening / progression
Other Name: CP-4126
Drug: Gemcitabine
Step 1: Dose escalation oral CP-4126 until maximum tolerated dose Step 2: Oral CP-4126 day 8 and 15 + IV Gemcitabine 1000 mg/m2 day 1 in a 4 week schedule until complete response or disease worsening / progression
Other Name: Gemcitabine

Detailed Description:

This is a multicentre clinical study conducted in Belgium and in The Netherlands. The study is a phase I divided in 2 steps: The first step is a dose escalation to define the RD. At the second step the PK profile of oral CP-4126 will be compared with the PK profile of IV gemcitabine. In addition, the study is conducted to characterize the tolerability of oral CP-4126, to evaluate its bioavailability, and to make a preliminary assessment of antitumor activity in patients with solid tumours.

  Eligibility

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

Inclusion Criteria:

  1. Histologically or cytologically confirmed solid tumour diagnosis
  2. Locally advanced or metastatic disease, for which there is no known effective treatment
  3. Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
  4. Age 18 years or more
  5. Life expectancy > 3 months
  6. Adequate hematological and biological functions:
  7. Signed informed consent

Exclusion Criteria:

  1. Symptomatic brain metastases
  2. Current peripheral neuropathy of grade > 1 according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
  3. Radiotherapy

    • to more than 30 % of bone marrow
    • single dose up to 8 Gy
    • less than one week prior to the study treatment
    • of the upper GI tract
  4. Mucositis of the upper digestive tract, including stomatitis
  5. Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
  6. Previous anticancer therapy (chemotherapy, hormone therapy or immunotherapy) within 30 days prior to the first dose of oral CP-4126 [6 weeks for mitomycin C and BCNU (= carmustine) and CCNU (=lomustine)]
  7. Requirement of concomitant treatment with a non-permitted medication including alternative drugs and high doses of vitamins
  8. History of allergic reactions to gemcitabine
  9. Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
  10. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
  11. Pregnant or breast feeding women
  12. Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for six months after last treatment
  13. Known positive status for HIV and/or hepatitis B or C
  14. Any reason why, in the investigator's opinion, the patient should not participate
  15. Condition that impairs ability to swallow pills
  16. Coeliac disease or any other lipid malabsorption syndrome
  17. Drug and/or alcohol abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778128

Locations
Belgium
Institute Jules Bordet
Brussels, Belgium, 1000
Netherlands
The Netherlands Cancer Institute
Amsterdam, Netherlands
University Medical Centre Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
Clavis Pharma
Investigators
Principal Investigator: Ahmad H Awada, MD Institute Jules Bordet
  More Information

No publications provided by Clavis Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Trygve Bergeland, Clavis Pharma ASA
ClinicalTrials.gov Identifier: NCT00778128     History of Changes
Other Study ID Numbers: CP4126-111
Study First Received: October 22, 2008
Last Updated: September 3, 2010
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Clavis Pharma:
CP-4126
Cancer
Metastatic
Solid tumours
Gemzitabine
Gemzar

Additional relevant MeSH terms:
Neoplasms
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 22, 2014