Advanced CancersPhase 1NCT00473720
Phase I Study of the Combination of Satraplatin and Abraxane in Advanced Cancers
A Phase 1 study testing Satraplatin and Abraxane in people with Advanced Cancers, run by Yale University at 1 site in United States.
Trial summary
This is a phase I dose escalating study of oral satraplatin in combination with Abraxane administered weekly for three out of every four weeks in patients with advanced solid cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Satraplatin and Abraxane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jun 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
- Patients must have histologically-confirmed advanced solid tumors.
- The patients must be refractory to standard therapy or have a tumor for which no therapy with clinical benefit exists.
- Patients should have evidence of disease progression if they received a prior therapy. This includes development of new lesions or an increase in preexisting lesions on bone scintigraphy, CT, MRI or by physical examination. Patients in whom the sole criterion for progression is an increase in a biochemical marker, e.g., carcinoembryonic antigen (CEA), or an increase in symptoms, are not eligible, with the exception of the biochemical marker PSA (prostate specific antigen).
- No radiotherapy, treatment with cytotoxic agents, or treatment with biologic agents within the 4 weeks prior to beginning treatment on this study (6 weeks for mitomycin or nitrosoureas). Patients must have fully recovered from the acute toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment). Patients with persisting, stable chronic toxicities from prior treatment ≤ grade 1 are eligible.
- All non-prostate cancer patients need to be at least 2 weeks off any hormonal therapy. Prostate cancer patients need to be maintained with castrate levels of testosterone and at least 2 weeks off any non steroidal anti-androgen, diethylstilbestrol, or ketoconazole.
- At least 2 weeks must have elapsed from any prior surgery .
Show all 13Show fewer
- Age ≥18 years.
- ECOG performance status ≤2 (Karnofsky ≥60%).
- Life expectancy of greater than 3 months.
- Patients must have normal organ and marrow function as defined below:
- Hemoglobin ≥ 9 g/dL leukocytes ≥3,000/mcL absolute neutrophil count ≥1,500/mcL platelets ≥100,000/mcL total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT) ≤2.5 x institutional upper limit of normal creatinine within 1.5 x ULN OR creatinine clearance ≥50 mL/min/1.73 m² for patients with creatinine levels above institutional normal.
- Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Pregnant and nursing patients are excluded because the effects of the combination of Abraxane and Satraplatin on a fetus or nursing child are unknown. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Sexually active men must also use appropriate contraception method and should not father a child while receiving therapy during this study.
- Must be able to understand and sign a written informed consent document.
Who cannot join
- Patients who are less than 4 weeks from chemotherapy or radiotherapy, or have not recovered from any adverse events
- Patients receiving any other investigational agents.
- Patients with known active brain metastases. Patients with treated brain metastases are eligible if they have received radiation to the brain or surgery, more than 4 weeks prior to enrollment onto this study, and do not have progression of their central nervous system disease radiologically or clinically. Such patients should be off steroids for a minimum of two weeks prior to the first dose on study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.
- Peripheral neuropathy ≥ Grade 2
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Show all 9Show fewer
- Pregnant women are excluded from this study because the investigational agents may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated.
- HIV-positive patients are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy and the potential pharmacokinetic interaction between antiretroviral therapy and the investigational agents.
- Concomitant use of certain medications that inhibit the liver microsomal enzyme CYP3A4 and CYP2CA8/9 may result in increased levels of Satraplatin and/or Abraxane. This increase may be clinically relevant because toxicities are related to dose and exposure. Therefore, all herbal and alternative medications should be discontinued while on study, these include: Hydrastis canadensis (goldenseal), Uncaria tomentosa (cat's claw), Echinacea angustifolia roots, trifolium pratense (wild cherry), matricaria chamomila (chamomile), and Glycyrrhiza glabra (licorice), dillapiol, and naringenim. No concomitant use of the following drugs is allowed: cyclosporine, diltiazem, ketoconazole, rifampin, fluconazole, delavirdine, nicardipine, pioglitazone, and sulfonamides, St Johns Wort. Consumption of grapefruit juice is prohibited during the study. Patients will be asked as to which medicines (traditional or herbal) they are taking at every study visit. If possible, these medications and/or all herbal medicines should not be restarted until 72 hours after the last drug dose on study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University, Comprehensive Cancer Center
New Haven, Connecticut, 06520
About this study
Official title: Phase I Dose Finding Study of the Orally Bioavailable Platinum Analog Satraplatin in Combination With Abraxane (Paclitaxel Protein-bound Particles) in Advanced Cancers
This is a phase I dose escalating study of oral satraplatin in combination with Abraxane administered weekly for three out of every four weeks in patients with advanced solid cancers.
- Conditions
- Advanced Cancers
- Being tested
- Satraplatin, Abraxane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SatraplatinDrug
Also called platinum analog
Dose escalation of 40, 60 and 80 mg/m²/day on days 1-5
AbraxaneDrug
Also called Paclitaxel protein-bound particles
Dose escalation of 80 and 100 mg/mm²/day on days 1,8,15,22 every 28 days
| Study group | Role | What they receive |
|---|---|---|
| satraplatin abraxane | Experimental | Satraplatin and abraxane will be given in escalating cohorts on a 3 + 3 design from satraplatin 40mg/m2 and abraxane 80mg/m2 Receives: Drug: Satraplatin; Drug: Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine a safe dose of oral Satraplatin to be administered for 5 consecutive days every week in combination with a 30 minute infusion of Abraxane administered weekly for 3 weeks out of 4 weeks.
Measured: Upon completion of dose escalation and determination of MTD
Secondary outcomes (3)
To determine the toxicity profile of Satraplatin combined with Abraxane
Measured: Upon completion of study
To determine the anti-tumor effect of the combination of Satraplatin and Abraxane
Measured: Upon completion of study
To determine if the administration of Satraplatin alters the pharmacokinetic profile of weekly Abraxane
Measured: Upon completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Agennix
- Responsible party
- Principal investigator, Hari Deshpande, Yale University
- Investigators
- Hari Deshpande, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473720
- Sponsor's protocol ID
- 0606001535
- Status last verified
- Jan 2013
- First submitted
- 11 May 2007
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Finding Study of the Orally Bioavailable Platinum Analog Satraplatin in Combination With Abraxane (Paclitaxel Protein-bound Particles) in Advanced Cancers
- ClinicalTrials.gov ID
- NCT00473720
- Acronym / sponsor ID
- 0606001535
- Conditions
- Advanced Cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Agennix
- Study start
- May 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 May 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 is a phase I dose escalating study of oral satraplatin in combination with Abraxane administered weekly for three out of every four weeks in patients with advanced solid cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| satraplatin abraxane | Experimental | Drug: Satraplatin, Drug: AbraxaneSatraplatin and abraxane will be given in escalating cohorts on a 3 + 3 design from satraplatin 40mg/m2 and abraxane 80mg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must have histologically-confirmed advanced solid tumors.
- The patients must be refractory to standard therapy or have a tumor for which no therapy with clinical benefit exists.
- Patients should have evidence of disease progression if they received a prior therapy. This includes development of new lesions or an increase in preexisting lesions on bone scintigraphy, CT, MRI or by physical examination. Patients in whom the sole criterion for progression is an increase in a biochemical marker, e.g., carcinoembryonic antigen (CEA), or an increase in symptoms, are not eligible, with the exception of the biochemical marker PSA (prostate specific antigen).
- No radiotherapy, treatment with cytotoxic agents, or treatment with biologic agents within the 4 weeks prior to beginning treatment on this study (6 weeks for mitomycin or nitrosoureas). Patients must have fully recovered from the acute toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment). Patients with persisting, stable chronic toxicities from prior treatment ≤ grade 1 are eligible.
- All non-prostate cancer patients need to be at least 2 weeks off any hormonal therapy. Prostate cancer patients need to be maintained with castrate levels of testosterone and at least 2 weeks off any non steroidal anti-androgen, diethylstilbestrol, or ketoconazole.
Key exclusion criteria (9 listed)
- Patients who are less than 4 weeks from chemotherapy or radiotherapy, or have not recovered from any adverse events
- Patients receiving any other investigational agents.
- Patients with known active brain metastases. Patients with treated brain metastases are eligible if they have received radiation to the brain or surgery, more than 4 weeks prior to enrollment onto this study, and do not have progression of their central nervous system disease radiologically or clinically. Such patients should be off steroids for a minimum of two weeks prior to the first dose on study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.
- Peripheral neuropathy ≥ Grade 2
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 |
|---|---|---|
| SatraplatinAlso: platinum analogDose escalation of 40, 60 and 80 mg/m²/day on days 1-5 | Drug | satraplatin abraxane |
| AbraxaneAlso: Paclitaxel protein-bound particlesDose escalation of 80 and 100 mg/mm²/day on days 1,8,15,22 every 28 days | Drug | satraplatin abraxane |
Primary outcome
To determine a safe dose of oral Satraplatin to be administered for 5 consecutive days every week in combination with a 30 minute infusion of Abraxane administered weekly for 3 weeks out of 4 weeks.
Time frame: Upon completion of dose escalation and determination of MTD
3 secondary outcomes
To determine the toxicity profile of Satraplatin combined with Abraxane
Time frame: Upon completion of study
To determine the anti-tumor effect of the combination of Satraplatin and Abraxane
Time frame: Upon completion of study
To determine if the administration of Satraplatin alters the pharmacokinetic profile of weekly Abraxane
Time frame: Upon completion of study
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 23 Jan 2013.
Related trials for Advanced Cancers
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
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 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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.
Hari Deshpande, M.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Satraplatin and Abraxane in people with Advanced Cancers, run by Yale University at 1 site 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 13 inclusion and 9 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 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To determine a safe dose of oral Satraplatin to be administered for 5 consecutive days every week in combination with a 30 minute infusion of Abraxane administered weekly for 3 weeks out of 4 weeks. (time frame: Upon completion of dose escalation and determination of MTD). 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 23 Jan 2013.