Solid TumorsPhase 1NCT00778128
A Phase I Clinical Study of Oral CP-4126 in Patients With Advanced Solid Tumour
A Phase 1 study testing CP-4126 and Gemcitabine in people with Solid Tumors, run by Clavis Pharma at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- CP-4126 and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2008to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed solid tumour diagnosis
- Locally advanced or metastatic disease, for which there is no known effective treatment
- Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
- Age 18 years or more
- Life expectancy > 3 months
- Adequate hematological and biological functions:
- Signed informed consent
Who cannot join
- Symptomatic brain metastases
- Current peripheral neuropathy of grade > 1 according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
- Radiotherapy
- to more than 30 % of bone marrow
- single dose up to 8 Gy
- less than one week prior to the study treatment
Show all 21Show fewer
- of the upper GI tract
- Mucositis of the upper digestive tract, including stomatitis
- Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
- 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)]
- Requirement of concomitant treatment with a non-permitted medication including alternative drugs and high doses of vitamins
- History of allergic reactions to gemcitabine
- Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
- Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
- Pregnant or breast feeding women
- 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
- Known positive status for HIV and/or hepatitis B or C
- Any reason why, in the investigator's opinion, the patient should not participate
- Condition that impairs ability to swallow pills
- Coeliac disease or any other lipid malabsorption syndrome
- Drug and/or alcohol abuse
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Netherlands2 sites
The Netherlands Cancer Institute
Amsterdam
University Medical Centre Utrecht
Utrecht
About this study
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.
Read the 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.
- Conditions
- Solid Tumors
- Being tested
- CP-4126, Gemcitabine
- Keywords
- CP-4126, Cancer, Metastatic, Solid tumours, Gemzitabine, Gemzar
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-4126Drug
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
GemcitabineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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. Receives: Drug: CP-4126; Drug: Gemcitabine |
| 2 | Experimental | 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. Receives: Drug: CP-4126; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step 1: MTD of oral CP-4126 in patients with advanced solid tumours, followed by establishing the recommended dose
Measured: 6 months
Step 2: Pharmacokinetic parameters comparison of oral CP-4126 with IV gemcitabine
Measured: 12 months
Secondary outcomes (3)
Tolerability of oral CP-4126
Measured: 12 months
Biovailability of oral CP-4126
Measured: 12 months
Preliminary assessment of antitumor activity of oral CP-4126
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clavis Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ahmad H Awada, MD, Principal investigator, Institute Jules Bordet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778128
- Sponsor's protocol ID
- CP4126-111
- Status last verified
- Sep 2010
- First submitted
- 22 Oct 2008
- Last updated
- 6 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Stuurman FE, Voest EE, Awada A, Witteveen PO, Bergeland T, Hals PA, Rasch W, Schellens JH, Hendlisz A. Phase I study of oral CP-4126, a gemcitabine derivative, in patients with advanced solid tumors. Invest New Drugs. 2013 Aug;31(4):959-66. doi: 10.1007/s10637-013-9925-z. Epub 2013 Jan 24.
PubMed 23345000
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of Oral CP-4126 in Patients With Advanced Solid Tumour
- ClinicalTrials.gov ID
- NCT00778128
- Acronym / sponsor ID
- CP4126-111
- Conditions
- Solid Tumors
- Keywords
- CP-4126, Cancer, Metastatic, Solid tumours, Gemzitabine, Gemzar
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Clavis PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CP-4126, Drug: GemcitabineStep 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. |
| 2 | Experimental | Drug: CP-4126, Drug: GemcitabineStep 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed solid tumour diagnosis
- Locally advanced or metastatic disease, for which there is no known effective treatment
- Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
- Age 18 years or more
- Life expectancy > 3 months
Key exclusion criteria (21 listed)
- Symptomatic brain metastases
- Current peripheral neuropathy of grade > 1 according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
- Radiotherapy
- Mucositis of the upper digestive tract, including stomatitis
- Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP-4126Step 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 | Drug | 1, 2 |
| GemcitabineStep 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 | Drug | 1, 2 |
Primary outcome
Step 1: MTD of oral CP-4126 in patients with advanced solid tumours, followed by establishing the recommended dose
Time frame: 6 months
Step 2: Pharmacokinetic parameters comparison of oral CP-4126 with IV gemcitabine
Time frame: 12 months
3 secondary outcomes
Tolerability of oral CP-4126
Time frame: 12 months
Biovailability of oral CP-4126
Time frame: 12 months
Preliminary assessment of antitumor activity of oral CP-4126
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2010.
- Derived from this study: PubMed 23345000Stuurman FE, Voest EE, Awada A, Witteveen PO, Bergeland T, Hals PA, Rasch W, Schellens JH, Hendlisz A. Phase I study of oral CP-4126, a gemcitabine derivative, in patients with advanced solid tumors. Invest New Drugs. 2013 Aug;31(4):959-66. doi: 10.1007/s10637-013-9925-z. Epub 2013 Jan 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad H Awada, MD principal investigator
Institute Jules Bordet
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CP-4126 and Gemcitabine in people with Solid Tumors, run by Clavis Pharma at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step 1: MTD of oral CP-4126 in patients with advanced solid tumours, followed by establishing the recommended dose (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00778128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2010.