Advanced Solid TumorsPhase 1NCT00692354
Safety Study to Evaluate CHR-2797 in Patients With Advanced Tumours
A Phase 1 study testing CHR-2797 (tosedostat) in people with Advanced Solid Tumors, run by Chroma Therapeutics.
Trial summary
The primary objective of this study was to determine the safety, tolerability, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of CHR-2797 when administered orally, once daily, to patients with advanced solid tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- CHR-2797 (tosedostat)
- Type of treatment
- Pill or oral medicine
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Mar 2008
- 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
- Signed, informed consent
- Histological or cytologically confirmed malignant solid tumour refractory to standard therapy or for which no standard therapy exists
- Evaluable disease
- Recovered from the acute adverse effects of prior therapies (excluding alopecia and grade 1 neuropathy)
- Adequate bone marrow, hepatic and renal function including the following:
- Hb ≥ 9.0 g/dl, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 100x109/L
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- Total bilirubin ≤ 1.5 x upper normal limit
- AST and ALT ≤ 2.5 x upper normal limit (or ≤ 5 x UNL in the presence of liver metastases)
- Creatinine ≤1.5 x upper normal limit
- Age < 18 years
- Performance status (PS) < 2 (ECOG scale)
- Estimated life expectancy greater than 3 months
- Female patients with reproductive potential had to have a negative serum pregnancy test within 7 days of treatment. Both women and men had to agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment. Acceptable methods of contraception included IUD, oral contraceptive, sub-dermal implant and double barrier (condom with a contraceptive sponge or contraceptive pessary)
Who cannot join
- Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to study entry (or a longer period depending on the defined characteristics of the agents used e.g. 6 weeks for mitomycin or nitrosourea). In patients with progressive disease (PD), continuation of LHRH agonists for prostate cancer, bisphosphonates for bone disease and corticosteroids was permitted provided the dose was stable before and during the study
- Co-existing active infection or serious concurrent illness
- Significant cardiovascular disease as defined by
- History of congestive heart failure requiring therapy
- History of unstable angina pectoris or myocardial infarction up to 6 months prior to study entry
- Presence of severe valvular heart disease
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- Presence of a ventricular arrhythmia requiring treatment
- Any co-existing medical condition that in the Investigator's judgement substantially increased the risk associated with the patient's participation in the study
- Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
- Gastrointestinal disorders that might have interfered with absorption of the study drug
- Persistent grade 2 or greater toxicities from any cause
- Patients with known brain tumours or metastases should have been excluded from this clinical study because of their poor prognosis and because they often develop progressive neurologic dysfunction that would have confounded the evaluation of neurologic and other AEs
- Pregnant or breast-feeding women
About this study
Official title: A Phase I Study to Evaluate the Safety and Tolerability, of the Aminopeptidase Inhibitor, CHR-2797, in Patients With Advanced Tumours
The primary objective of this study was to determine the safety, tolerability, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of CHR-2797 when administered orally, once daily, to patients with advanced solid tumours.
The secondary objectives of this study were:
- To determine pharmacokinetic parameters for CHR-2797 when administered orally at increasing dose levels;
- To investigate the pharmacodynamic effects of CHR-2797 in blood mononuclear cells and, when possible, tumour cells; - To enable a preliminary assessment of anti-tumour activity of CHR-2797.
- Conditions
- Advanced Solid Tumors
- Being tested
- CHR-2797 (tosedostat)
- Keywords
- Advanced, Solid, Tumour, Tumor, Oral
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHR-2797 (tosedostat)Drug
Drug was given orally, once daily, ensuring a dosing interval of approximately 24 hours. Dose escalations took place starting at 10mg and escalating (per protocol) as follows: 20, 40, 90, 130, 180, 240 and 320 mg
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety, tolerability, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of CHR-2797 when administered orally, once daily, to patients with advanced solid tumours.
Measured: 3 years
Secondary outcomes (3)
To determine the PK parameters for oral CHR-2797 at increasing dose levels;
Measured: 3 years
To investigate the PD effects of CHR-2797 in blood and tumour cells
Measured: 3 years
To enable a preliminary assessment of anti-tumour activity of CHR-2797
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startOct 2004
- Primary completionNov 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chroma Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692354
- Sponsor's protocol ID
- CHR-2797-001
- Status last verified
- Jun 2008
- First submitted
- 4 Jun 2008
- Last updated
- 6 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Tolerability, of the Aminopeptidase Inhibitor, CHR-2797, in Patients With Advanced Tumours
- ClinicalTrials.gov ID
- NCT00692354
- Acronym / sponsor ID
- CHR-2797-001
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced, Solid, Tumour, Tumor, Oral
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Chroma TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Institute of Cancer Research, United Kingdom
- Study start
- Oct 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 6 Jun 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.
The primary objective of this study was to determine the safety, tolerability, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of CHR-2797 when administered orally, once daily, to patients with advanced solid tumours.
The secondary objectives of this study were:
- To determine pharmacokinetic parameters for CHR-2797 when administered orally at increasing dose levels;
- To investigate the pharmacodynamic effects of CHR-2797 in blood mononuclear cells and, when possible, tumour cells; - To enable a preliminary assessment of anti-tumour activity of CHR-2797.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed, informed consent
- Histological or cytologically confirmed malignant solid tumour refractory to standard therapy or for which no standard therapy exists
- Evaluable disease
- Recovered from the acute adverse effects of prior therapies (excluding alopecia and grade 1 neuropathy)
- Adequate bone marrow, hepatic and renal function including the following:
Key exclusion criteria (13 listed)
- Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to study entry (or a longer period depending on the defined characteristics of the agents used e.g. 6 weeks for mitomycin or nitrosourea). In patients with progressive disease (PD), continuation of LHRH agonists for prostate cancer, bisphosphonates for bone disease and corticosteroids was permitted provided the dose was stable before and during the study
- Co-existing active infection or serious concurrent illness
- Significant cardiovascular disease as defined by
- Any co-existing medical condition that in the Investigator's judgement substantially increased the risk associated with the patient's participation in the study
- Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
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 |
|---|---|---|
| CHR-2797 (tosedostat)Drug was given orally, once daily, ensuring a dosing interval of approximately 24 hours. Dose escalations took place starting at 10mg and escalating (per protocol) as follows: 20, 40, 90, 130, 180, 240 and 320 mg | Drug | – |
Primary outcome
To determine the safety, tolerability, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of CHR-2797 when administered orally, once daily, to patients with advanced solid tumours.
Time frame: 3 years
3 secondary outcomes
To determine the PK parameters for oral CHR-2797 at increasing dose levels;
Time frame: 3 years
To investigate the PD effects of CHR-2797 in blood and tumour cells
Time frame: 3 years
To enable a preliminary assessment of anti-tumour activity of CHR-2797
Time frame: 3 years
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 Aug 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHR-2797 (tosedostat) in people with Advanced Solid Tumors, run by Chroma Therapeutics.
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 13 inclusion and 13 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 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
To determine the safety, tolerability, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of CHR-2797 when administered orally, once daily, to patients with advanced solid tumours. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2010.