Carcinoma, Renal CellPhase 2NCT00422786
Phase II Study of CAP-232 in Patients With Refractory Metastatic Renal Cell Carcinoma
A Phase 2 study testing CAP-232 in people with Carcinoma, Renal Cell, run by Thallion Pharmaceuticals at 2 sites in France.
Trial summary
The purpose of this study was to evaluate the safety and efficacy of CAP-232 in the treatment of patients with previously treated (refractory) renal cell carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- CAP-232
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2007to Mar 2008
- Phase
- Phase 2
- 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 confirmed stage IV kidney clear cell carcinoma.
- Confirmed progressive disease after receiving a previous systemic therapy, including at least one line of standard of care.
- Measurable disease
- Age >18 years.
- Life expectancy of greater than 3 months.
- At least 5 years free of any other cancer(s). Basal cell carcinoma, provided that is neither infiltrating nor sclerosing and carcinoma in situ of the cervix, is acceptable.
Show all 12Show fewer
- ECOG performance status 2 or lower (Karnofsky 60%).
- Normal organ and marrow function
- Adequate contraception prior to study entry and for the duration of study participation.
- Ability to understand and have the willingness to sign a written informed consent document.
- Ability to receive central vein access catheter and manage an infusion pump.
- Women of child bearing potential must have a negative serum pregnancy test.
Who cannot join
- Anti-cancer therapy within 4 weeks prior to entering the study
- Investigational agents less than 30 days prior to enrollment in the study.
- Known brain metastases
- History of allergic reactions attributed to compounds of similar composition to CAP-232.
- Past or current cancer other than kidney cancer, except for: Curatively treated non-melanoma skin cancer, In situ carcinoma of the cervix, Other cancer curatively treated and with no evidence of disease for at least 5 years
- Uncontrolled intercurrent illness /social situations that would limit compliance with study requirements.
- Breastfeeding
- Patients previously enrolled into this study and subsequently withdrawn
Trial locations and contacts
2 sites in 1 country.
France2 sites
CRLC Val d'Aurelle Paul-Lamarque
Montpellier, 34298
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42270
About this study
Official title: A Multi-Centre, Open Label, Phase II Study of the Safety, Efficacy and Pharmacokinetic (PK) Profile of CAP-232 Administered Through Continuous Intravenous Infusion in Patients With Metastatic Kidney Cancer
The purpose of this study was to evaluate the safety and efficacy of CAP-232 in the treatment of patients with previously treated (refractory) renal cell carcinoma
Read the detailed description
This was a multi-center, open label, single arm study. Approximately 40 patients were initially planned to be recruited.
Each patient was to receive a treatment cycle consisting of CAP-232 via continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period. Treatment cycles to be repeated in the absence of disease progression or unacceptable toxicity.
Quality of Life questionnaires were to be administered at baseline, after each visit and at the end of the study.
Signs and symptoms of adverse events were closely monitored during treatment cycles. Safety laboratory measures were done at Screening, during the 72hr hospitalization (first cycle), at every interim visit , and at the end of the study. A follow-up safety visit was to be scheduled at least 30 days after the end of treatment.
CAP-232 plasma levels were also determined.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- CAP-232
- Keywords
- Refractory Clear Cell Renal Cell Carcinoma, Phase II, Thallion, TLN-232, CAP-232, M2PK
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAP-232Drug
Also called TLN-232
Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period
| Study group | Role | What they receive |
|---|---|---|
| CAP-232 | Experimental | Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period. Receives: Drug: CAP-232 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy parameter was the response rate based on RECIST criteria after 3 cycles
Secondary outcomes (5)
Safety (through clinical and biological evaluations)
Other efficacy parameters (progression-free survival rate, time to progression and overall survival)
Pharmacokinetic (PK) characteristics of the first 15 recruited patients
Quality of life
Biological modulation (through potential blood and/or urine biomarkers including M2PK)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Renal CellStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thallion Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Aline Guillot, MD, Principal investigator, Institut de Cancérologie de la Loire, Dpt Oncologie Médicale, Saint-Priest en Jarez, FranceDamien Pouessel, MD, Principal investigator, CRLC Val d'Aurelle Paul-Lamarque, Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422786
- Sponsor's protocol ID
- CTP_CAP001
- Status last verified
- Jul 2008
- First submitted
- 12 Jan 2007
- Last updated
- 15 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tejeda M, Gaal D, Hullan L, Hegymegi-Barakonyi B, Keri G. Evaluation of the antitumor efficacy of the somatostatin structural derivative TT-232 on different tumor models. Anticancer Res. 2006 Sep-Oct;26(5A):3477-83.
PubMed 17094470Tejeda M, Gaal D, Hullan L, Csuka O, Schwab R, Szokoloczi O, Keri G. A comparison of the tumor growth inhibitory effect of intermittent and continuous administration of the somatostatin structural derivative TT-232 in various human tumor models. Anticancer Res. 2006 Jul-Aug;26(4B):3011-5.
PubMed 16886628Gyergyay F, Gödény M, Sármay G, Kralovanszky J, Papp E, Gergye M, Vincze B, Kéri G, Bodrogi I : Antitumor activity and pharmacology of TT-232 (a novel somatostatin structural derivative) in malignant melanoma patients JCO, 2004 ASCO Annual Meeting Proceedings Vol 22, No 14S (July 15 Supplement), 2004: 3151
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Open Label, Phase II Study of the Safety, Efficacy and Pharmacokinetic (PK) Profile of CAP-232 Administered Through Continuous Intravenous Infusion in Patients With Metastatic Kidney Cancer
- ClinicalTrials.gov ID
- NCT00422786
- Acronym / sponsor ID
- CTP_CAP001
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Refractory Clear Cell Renal Cell Carcinoma, Phase II, Thallion, TLN-232, CAP-232, M2PK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Thallion PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 17 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.
The purpose of this study was to evaluate the safety and efficacy of CAP-232 in the treatment of patients with previously treated (refractory) renal cell carcinoma
Detailed description
This was a multi-center, open label, single arm study. Approximately 40 patients were initially planned to be recruited.
Each patient was to receive a treatment cycle consisting of CAP-232 via continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period. Treatment cycles to be repeated in the absence of disease progression or unacceptable toxicity.
Quality of Life questionnaires were to be administered at baseline, after each visit and at the end of the study.
Signs and symptoms of adverse events were closely monitored during treatment cycles. Safety laboratory measures were done at Screening, during the 72hr hospitalization (first cycle), at every interim visit , and at the end of the study. A follow-up safety visit was to be scheduled at least 30 days after the end of treatment.
CAP-232 plasma levels were also determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAP-232 | Experimental | Drug: CAP-232Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed stage IV kidney clear cell carcinoma.
- Confirmed progressive disease after receiving a previous systemic therapy, including at least one line of standard of care.
- Measurable disease
- Age >18 years.
- Life expectancy of greater than 3 months.
Key exclusion criteria (8 listed)
- Anti-cancer therapy within 4 weeks prior to entering the study
- Investigational agents less than 30 days prior to enrollment in the study.
- Known brain metastases
- History of allergic reactions attributed to compounds of similar composition to CAP-232.
- Past or current cancer other than kidney cancer, except for: Curatively treated non-melanoma skin cancer, In situ carcinoma of the cervix, Other cancer curatively treated and with no evidence of disease for at least 5 years
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 |
|---|---|---|
| CAP-232Also: TLN-232Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period | Drug | CAP-232 |
Primary outcome
The primary efficacy parameter was the response rate based on RECIST criteria after 3 cycles
5 secondary outcomes
Safety (through clinical and biological evaluations)
Other efficacy parameters (progression-free survival rate, time to progression and overall survival)
Pharmacokinetic (PK) characteristics of the first 15 recruited patients
Quality of life
Biological modulation (through potential blood and/or urine biomarkers including M2PK)
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 15 Jul 2008.
- Background: PubMed 17094470Tejeda M, Gaal D, Hullan L, Hegymegi-Barakonyi B, Keri G. Evaluation of the antitumor efficacy of the somatostatin structural derivative TT-232 on different tumor models. Anticancer Res. 2006 Sep-Oct;26(5A):3477-83.
- Background: PubMed 16886628Tejeda M, Gaal D, Hullan L, Csuka O, Schwab R, Szokoloczi O, Keri G. A comparison of the tumor growth inhibitory effect of intermittent and continuous administration of the somatostatin structural derivative TT-232 in various human tumor models. Anticancer Res. 2006 Jul-Aug;26(4B):3011-5.
- BackgroundGyergyay F, Gödény M, Sármay G, Kralovanszky J, Papp E, Gergye M, Vincze B, Kéri G, Bodrogi I : Antitumor activity and pharmacology of TT-232 (a novel somatostatin structural derivative) in malignant melanoma patients JCO, 2004 ASCO Annual Meeting Proceedings Vol 22, No 14S (July 15 Supplement), 2004: 3151
Related trials for Carcinoma, Renal Cell
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 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal 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.
Aline Guillot, MD principal investigator
Institut de Cancérologie de la Loire, Dpt Oncologie Médicale, Saint-Priest en Jarez, France
Damien Pouessel, MD principal investigator
CRLC Val d'Aurelle Paul-Lamarque, Montpellier, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAP-232 in people with Carcinoma, Renal Cell, run by Thallion Pharmaceuticals at 2 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?
The sponsor lists 12 inclusion and 8 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 15 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary efficacy parameter was the response rate based on RECIST criteria after 3 cycles. 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 NCT00422786, which also lists 3 linked publications.
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 15 Jul 2008.