Solid TumorsPhase 1PACIFIKNCT01165385
Study With Pazopanib in Combination With Cisplatin (CDDP) in Patients With Advanced Solid Tumors
A Phase 1 study testing cisplatin and Pazopanib in people with Solid Tumors and Metastatic Cancer, run by UNICANCER at 5 sites in France.
Trial summary
The aim of this research is to evaluate the potential interest of an association of Pazopanib, a multi-tyrosine kinase inhibitor, and cisplatin. As cisplatin has marketing approval for several cancers (ovarian, testicle, bladder, esophagus, endometrium, lung, stomach, head and neck cancer (HNC)), and in order to have… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Metastatic Cancer
- What is being tested?
- cisplatin and Pazopanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesFrance
- Study dates
- Jun 2010to Oct 2014
- 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
Main Inclusion Criteria:
- Documented metastatic solid malignancies for patients who are candidate to receive a cisplatin based regimen.
- During the dose seeking procedure : ALL solid tumors
- During the Optimal Tolerated Regimen validation procedure : ONLY HER2-RH- breast cancer
- Measurable or evaluable disease
- WHO performance status ≤ 1
- Negative dipstick proteinuria test or if positive proteinuria <1g/24h. If proteinuria appears ≥ 2+ on routine dipstick testing, patients must undergo a 24H -urine collection and demonstrate proteinuria < 1g/24H
- Corrected QT interval (QTc) ≤ 480 msecs using Bazett's formula
Main Exclusion Criteria:
- Prior treatment with cisplatin reaching a cumulative dose> 300 mg/m2
- HER2 positive breast cancer
- Patients at high risk of bleeding
- Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product
- calcium and magnesium levels inferior to standard levels (measured within 14 days before the first pazopanib dose) and potassium levels inferior to standard levels (measured within 72 hours before the first pazopanib dose)
- Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study
- Hearing impairment/tinnitus > or = grade 2
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre François BACLESSE
Caen, 14076
Centre Georges François LECLERC
Dijon, 21079
Centre Léon Berard
Lyon, 69373 CEDEX 08
Centre René Gauducheau
Nantes Saint Herblain, 44805
Institut Curie
Paris, 75248
About this study
Official title: An Open Label Dose Escalation and Pharmacokinetic Phase I Study With Pazopanib in Combination With Cisplatin (CDDP) Every Three Weeks in Patients With Advanced Solid Tumors
The aim of this research is to evaluate the potential interest of an association of Pazopanib, a multi-tyrosine kinase inhibitor, and cisplatin.
As cisplatin has marketing approval for several cancers (ovarian, testicle, bladder, esophagus, endometrium, lung, stomach, head and neck cancer (HNC)), and in order to have a rapid evaluation of this combination, we will evaluate the combination in any patient whose tumors is known to be sensible to cisplatin (except tumors at risk of bleeding).
This study is a classical phase 1 trial of pazopanib and 3-weekly cisplatin association. It will allow for optimal dose selection and pharmacokinetic analysis. It is planed to include around 38 patients, enriching the optimal tolerated regimen (OTR) level only with a cohort of triple negative breast cancer patients. If the association is proven to be feasible, we will then move to a specific phase II study in triple negative breast cancer patients.
Read the detailed description
The main objective of the study is to determine the dose limiting toxicities (DLT) and the optimal tolerated regimen (OTR) which are both safety criteria evaluated upon the NCI CTC-AE system version 4.0.
Efficacy is not the primary objective; however the anti-tumor activity of the pazopanib/cisplatin combination will be carried out by the determination of the objective response rate according to RECIST criteria version 1.1.
The objective response is defined as either a complete response (CR) or partial response (PR), assessed either by CT Scan and/or MRI and/or bone Scan, performed at baseline and every 6 weeks.
This is an open-label, non-randomized, dose escalation and pharmacokinetic, phase I study pazopanib with cisplatin in patients with relapsed or refractory solid tumors (except tumors at risk of bleeding) for whom the selected combined chemotherapy is indicated or is a reasonable option (as per tumor characteristics and previous treatments).
All eligible patients entering the study will receive daily oral pazopanib, supplied as 200 mg aqueous film-coated tablets and intravenous cisplatin every three weeks. Doses of both compounds will be adjusted according to the reached dose level.
The treatment will continue until the development of unacceptable toxicity or evidence of disease progression or until patient's / investigator's decision of withdrawal.
All patients who received at least on dose of the study drug will be followed for survival outcome.
- Conditions
- Solid Tumors, Metastatic Cancer
- Being tested
- cisplatin, Pazopanib
- Keywords
- Relapsed or refractory solid tumors, Pazopanib, Cisplatin
- Medical subject headings
- Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
Also called Cisplatinum
60, 75 or 100 mg/m2 , day 1 - 3 weekly
PazopanibDrug
Also called GW76034
400 mg, 600 mg or 800 mg/day, daily
| Study group | Role | What they receive |
|---|---|---|
| Pazopanib and Cisplatin | Experimental | * Steady state period:Pazopanib will be given 8 days prior to cisplatin
* Then pazopanib will be given 400 mg, 600 mg or 800 mg/day, daily and cisplatin 60, 75 or 100 mg/m2 , day 1 - 3 weekly, depending of the dose level Receives: Drug: cisplatin; Drug: Pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the Optimal Tolerated Regimen (OTR) based on the occurrence of Dose Limiting Toxicities
Measured: cycles 1 and 2
Secondary outcomes (2)
Objective response - Overall Objective response rate - Clinical Benefit Rate
Anti-tumor activity of the pazopanib/cisplatin combination will be carried out by the determination of the objective response rate according to RECIST criteria version 1.1.
Measured: At baseline and every 6 weeks.
To characterize the pharmacokinetic (PK) profile of the combination pazopanib and cisplatin
The objective of the pharmacokinetics is to investigate the interactions between cisplatin IV and pazopanib
Measured: Cycles 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2013
- Study completionOct 2014
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.
- More trials run by UNICANCERThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronique DIERAS, MD, Study chair, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165385
- Sponsor's protocol ID
- GEP 07/0908 - PACIFIK
- Acronym
- PACIFIK
- Status last verified
- Nov 2014
- First submitted
- 25 Jun 2010
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dieras V, Bachelot T, Campone M, Isambert N, Joly F, Le Tourneau C, Cassier P, Bompas E, Fumoleau P, Noal S, Orsini C, Jimenez M, Imbs DC, Chatelut E. A Phase I, Dose-Escalation Trial of Pazopanib in Combination with Cisplatin in Patients with Advanced Solid Tumors: A UNICANCER Study. Oncol Ther. 2016;4(2):211-223. doi: 10.1007/s40487-016-0027-x. Epub 2016 Aug 18.
PubMed 28261651
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Dose Escalation and Pharmacokinetic Phase I Study With Pazopanib in Combination With Cisplatin (CDDP) Every Three Weeks in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01165385
- Acronym / sponsor ID
- PACIFIK / GEP 07/0908 - PACIFIK
- Conditions
- Solid Tumors, Metastatic Cancer
- Keywords
- Relapsed or refractory solid tumors, Pazopanib, Cisplatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Jul 2010 (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 aim of this research is to evaluate the potential interest of an association of Pazopanib, a multi-tyrosine kinase inhibitor, and cisplatin.
As cisplatin has marketing approval for several cancers (ovarian, testicle, bladder, esophagus, endometrium, lung, stomach, head and neck cancer (HNC)), and in order to have a rapid evaluation of this combination, we will evaluate the combination in any patient whose tumors is known to be sensible to cisplatin (except tumors at risk of bleeding).
This study is a classical phase 1 trial of pazopanib and 3-weekly cisplatin association. It will allow for optimal dose selection and pharmacokinetic analysis. It is planed to include around 38 patients, enriching the optimal tolerated regimen (OTR) level only with a cohort of triple negative breast cancer patients. If the association is proven to be feasible, we will then move to a specific phase II study in triple negative breast cancer patients.
Detailed description
The main objective of the study is to determine the dose limiting toxicities (DLT) and the optimal tolerated regimen (OTR) which are both safety criteria evaluated upon the NCI CTC-AE system version 4.0.
Efficacy is not the primary objective; however the anti-tumor activity of the pazopanib/cisplatin combination will be carried out by the determination of the objective response rate according to RECIST criteria version 1.1.
The objective response is defined as either a complete response (CR) or partial response (PR), assessed either by CT Scan and/or MRI and/or bone Scan, performed at baseline and every 6 weeks.
This is an open-label, non-randomized, dose escalation and pharmacokinetic, phase I study pazopanib with cisplatin in patients with relapsed or refractory solid tumors (except tumors at risk of bleeding) for whom the selected combined chemotherapy is indicated or is a reasonable option (as per tumor characteristics and previous treatments).
All eligible patients entering the study will receive daily oral pazopanib, supplied as 200 mg aqueous film-coated tablets and intravenous cisplatin every three weeks. Doses of both compounds will be adjusted according to the reached dose level.
The treatment will continue until the development of unacceptable toxicity or evidence of disease progression or until patient's / investigator's decision of withdrawal.
All patients who received at least on dose of the study drug will be followed for survival outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pazopanib and Cisplatin | Experimental | Drug: cisplatin, Drug: Pazopanib* Steady state period:Pazopanib will be given 8 days prior to cisplatin * Then pazopanib will be given 400 mg, 600 mg or 800 mg/day, daily and cisplatin 60, 75 or 100 mg/m2 , day 1 - 3 weekly, depending of the dose level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cisplatinAlso: Cisplatinum60, 75 or 100 mg/m2 , day 1 - 3 weekly | Drug | Pazopanib and Cisplatin |
| PazopanibAlso: GW76034400 mg, 600 mg or 800 mg/day, daily | Drug | Pazopanib and Cisplatin |
Primary outcome
Determination of the Optimal Tolerated Regimen (OTR) based on the occurrence of Dose Limiting Toxicities
Time frame: cycles 1 and 2
2 secondary outcomes
Objective response - Overall Objective response rate - Clinical Benefit Rate
Time frame: At baseline and every 6 weeks.
To characterize the pharmacokinetic (PK) profile of the combination pazopanib and cisplatin
Time frame: Cycles 1 and 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 17 Nov 2014.
- Derived from this study: PubMed 28261651Dieras V, Bachelot T, Campone M, Isambert N, Joly F, Le Tourneau C, Cassier P, Bompas E, Fumoleau P, Noal S, Orsini C, Jimenez M, Imbs DC, Chatelut E. A Phase I, Dose-Escalation Trial of Pazopanib in Combination with Cisplatin in Patients with Advanced Solid Tumors: A UNICANCER Study. Oncol Ther. 2016;4(2):211-223. doi: 10.1007/s40487-016-0027-x. Epub 2016 Aug 18.
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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.
Veronique DIERAS, MD study chair
Institut Curie
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 cisplatin and Pazopanib in people with Solid Tumors and Metastatic Cancer, run by UNICANCER at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Nov 2014. 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 France. 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?
Determination of the Optimal Tolerated Regimen (OTR) based on the occurrence of Dose Limiting Toxicities (time frame: cycles 1 and 2). 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 NCT01165385, 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 17 Nov 2014.