Advanced Solid TumorsPhase 1NCT00426582
Combination Trial of Patupilone and Carboplatin in Adult Patients With Advanced Solid Tumors
A Phase 1 study testing Patupilone in people with Advanced Solid Tumors, run by Novartis Pharmaceuticals at 5 sites in United States.
Trial summary
This study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone combined with carboplatin in adult patients with advanced solid tumors who progressed despite standard therapy or for whom no standard therapy exists or who might benefit from treatment with carboplatin 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?
- Patupilone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2006to Aug 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 advanced solid tumors who have progressed despite standard therapy, or for whom no standard therapy exists, or who might benefit from treatment with carboplatin
- A minimum of 4 weeks since the last treatment with chemotherapy
- WHO Performance Status 0 (able to carry out all normal activity without restriction) or 1 (restricted in physically strenuous activity but ambulatory and able to carry out work)
- Age ≥ 18
- Adequate hematological parameters
- No major impairment of renal or hepatic function
- Written informed consent obtained
Who cannot join
- Major surgery less than 4 weeks prior to study entry and/or not fully recovered from surgery
- Chemotherapy or investigational compound less than 4 weeks prior to study entry, or planned while participating in the study
- Prior administration of an epothilone
- Hypersensitivity to carboplatin. Patients resistant to carboplatin are not recommended to enter the trial
- Radiotherapy (RT) less than 4 weeks prior to study entry (except for palliative therapy of distant metastases), or planned RT while participating in the study
- Diarrhea within 7 days prior to start of treatment. Unresolved bowel obstruction
Show all 10Show fewer
- Peripheral neuropathy > Grade 1 (mild)
- Symptomatic brain metastases
- Colostomy
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cancer Research and Treatment Center (University of New Mexico)
Albuquerque, New Mexico, 87131
Wertz Clinical Cancer Center (Wayne State University)
Detroit, Michigan, 48201
Norwalk Hospital
Norwalk, Connecticut, 06856
Associates in Oncology
Rockville, Maryland, 20850
Siteman Cancer Center (Washington University School of Medicine)
St Louis, Missouri, 63110-1093
About this study
Official title: A Phase Ib, Multicenter, Open-label, Dose-finding Study of Patupilone Administered Intravenously Every 3 Weeks in Combination With Carboplatin AUC 6 in Adult Patients With Advanced Solid Tumors
This study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone combined with carboplatin in adult patients with advanced solid tumors who progressed despite standard therapy or for whom no standard therapy exists or who might benefit from treatment with carboplatin
- Conditions
- Advanced Solid Tumors
- Being tested
- Patupilone
- Keywords
- Cancer, maximum tolerated dose, dose-limiting toxicity, patupilone, carboplatin, pharmacokinetics
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatupiloneDrug
| Study group | Role | What they receive |
|---|---|---|
| Patupilone only | Experimental | Cycle 1 patupilone alone Cycle 2 and onward patupilone and carboplatin Receives: Drug: Patupilone |
| Carboplatin alone | Active comparator | Cycle 1 Carboplatin alone Cycle 2 and onward patuilone and carboplatin Receives: Drug: Patupilone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6)
Measured: Every 3 weeks
Secondary outcomes (5)
Safety of patupilone combined with carboplatin assessed by adverse events, serious adverse events, laboratory values and physical examinations
Measured: Every 6 weeks
Overall response rate (complete and partial response; CR + PR) according to RECIST (response evaluation criteria in solid tumors)
Measured: Every 6 weeks
Time to progression (TTP), duration of overall response, duration of stable disease and time to overall response
Measured: Every 6 weeks
Pharmacokinetic profile of patupilone combined with carboplatin
Measured: First 6 weeks (cycle 1 & 2 only)
Relationship between pharmacokinetics and clinical outcome
Measured: Every 6 weeks during cycle 1 & cycle 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2007 (estimated)
- Study startAug 2006
- Primary completionAug 2010
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.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426582
- Sponsor's protocol ID
- CEPO906A2105
- Status last verified
- Mar 2011
- First submitted
- 24 Jan 2007
- Last updated
- 9 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Multicenter, Open-label, Dose-finding Study of Patupilone Administered Intravenously Every 3 Weeks in Combination With Carboplatin AUC 6 in Adult Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00426582
- Acronym / sponsor ID
- CEPO906A2105
- Conditions
- Advanced Solid Tumors
- Keywords
- Cancer, maximum tolerated dose, dose-limiting toxicity, patupilone, carboplatin, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Aug 2010 (actual)
- First posted
- 25 Jan 2007 (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.
This study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone combined with carboplatin in adult patients with advanced solid tumors who progressed despite standard therapy or for whom no standard therapy exists or who might benefit from treatment with carboplatin
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patupilone only | Experimental | Drug: PatupiloneCycle 1 patupilone alone Cycle 2 and onward patupilone and carboplatin |
| Carboplatin alone | Active comparator | Drug: PatupiloneCycle 1 Carboplatin alone Cycle 2 and onward patuilone and carboplatin |
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 advanced solid tumors who have progressed despite standard therapy, or for whom no standard therapy exists, or who might benefit from treatment with carboplatin
- A minimum of 4 weeks since the last treatment with chemotherapy
- WHO Performance Status 0 (able to carry out all normal activity without restriction) or 1 (restricted in physically strenuous activity but ambulatory and able to carry out work)
- Age ≥ 18
- Adequate hematological parameters
Key exclusion criteria (10 listed)
- Major surgery less than 4 weeks prior to study entry and/or not fully recovered from surgery
- Chemotherapy or investigational compound less than 4 weeks prior to study entry, or planned while participating in the study
- Prior administration of an epothilone
- Hypersensitivity to carboplatin. Patients resistant to carboplatin are not recommended to enter the trial
- Radiotherapy (RT) less than 4 weeks prior to study entry (except for palliative therapy of distant metastases), or planned RT while participating in the 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 |
|---|---|---|
| Patupilone | Drug | Carboplatin alone, Patupilone only |
Primary outcome
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6)
Time frame: Every 3 weeks
5 secondary outcomes
Safety of patupilone combined with carboplatin assessed by adverse events, serious adverse events, laboratory values and physical examinations
Time frame: Every 6 weeks
Overall response rate (complete and partial response; CR + PR) according to RECIST (response evaluation criteria in solid tumors)
Time frame: Every 6 weeks
Time to progression (TTP), duration of overall response, duration of stable disease and time to overall response
Time frame: Every 6 weeks
Pharmacokinetic profile of patupilone combined with carboplatin
Time frame: First 6 weeks (cycle 1 & 2 only)
Relationship between pharmacokinetics and clinical outcome
Time frame: Every 6 weeks during cycle 1 & cycle 2
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 9 Dec 2020.
- Results can be found for CEPO906A2105 on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Novartis Pharmaceuticals study director
Novartis Pharmeceuticals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Patupilone in people with Advanced Solid Tumors, run by Novartis Pharmaceuticals at 5 sites in United States.
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 10 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 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6) (time frame: Every 3 weeks). 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 9 Dec 2020.