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CancerPhase 1NCT00551512

Phase I Study of CBP501 and Cisplatin in Patients With Advanced Refractory Solid Tumors

A Phase 1 study testing CBP501 and Cisplatin in people with Cancer and Solid Tumors, run by CanBas Co. Ltd. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research study is to find the answers to the following questions: 1. What are the highest doses of CBP501 and cisplatin that can be safely administered as consecutive 2-hours and 1-hour infusions every 21 days? 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Solid Tumors
What is being tested?
CBP501 and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
3 sitesUnited States
Study dates
Nov 2006to May 2009
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 obtained prior to initiation of any study-specific procedures.
  • Pathologically-confirmed, locally advanced or metastatic solid tumors, refractory to standard therapy.
  • Male or female patients aged 18 years or over.
  • ECOG Performance Status (PS): 0-1.
  • Life expectancy > 3 months.
  • Previous anticancer treatment must be discontinued at least 3 weeks prior to first dose of study treatment (6 weeks for mitomycin C; 6 weeks for anti-androgen therapy if discontinued prior to treatment initiation, with the exception of 8 weeks for bicalutamide).
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  • Adequate organ function including the following:
  • Bone Marrow: absolute neutrophil count (ANC) ³ 1.5 x 109/L, platelet count ³ 100 x 109/L, hemoglobin ³ 9 g/dL
  • Hepatic: Bilirubin £ 1.5 x the upper limit of normal (ULN), aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) £ 2.5 x ULN (or ≤ 5 x ULN if liver metastases are present), INR £ 1.5 x ULN
  • Renal: Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ³ 70 mL/min (calculated according to the Cockroft and Gault formula)
  • Metabolic: serum potassium, calcium and magnesium ³ lower limit of normal (LLN)
  • Creatine phosphokinase isoenzymes: CPK-MB, CPK-MM ≤ ULN
  • Troponin I serum level within normal values
  • Female patients of child-bearing potential must have a negative pregnancy test and use at least one form of contraception as approved by the investigator for 4 weeks prior to the study and 4 months after the last dose of study drug. For the purposes of this study, child-bearing potential is defined as: "All female patients unless they are post-menopausal for at least one year or are surgically sterile".
  • Male patients must use a form of barrier contraception approved by the investigator during the study and for 4 months after the last dose of study drug.
  • Ability to co-operate with the treatment and follow-up.

Who cannot join

  • Radiation therapy to more than 30% of the bone marrow prior to entry into the study.
  • Prior chemotherapy with nitrosoureas or high dose carboplatin (AUC > 6 mg/mL), prior mitomycin C cumulative dose ³ 25 mg/m², prior bone marrow transplant or intensive chemotherapy with stem cell support.
  • Presence of any serious concomitant systemic disorders incompatible with the study (e.g. uncontrolled congestive heart failure, active infection, etc.).
  • Any previous history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry.
  • Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance.
  • Evidence of peripheral neuropathy > grade 1 according to NCI-CTCAE Version 3.
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  • Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to study entry.
  • Pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception.
  • Known HIV, HBV, HCV infection.
  • Active CNS metastasis: patients with a history of CNS metastases will be eligible if they have been treated and are stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for > 1 week prior to enrollment.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • Scottsdale Clinical Research Institute

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: Phase I Clinical and Pharmacokinetic Study of CBP501 and Cisplatin Every 3 Weeks in Patients With Advanced Refractory Solid Tumors

The purpose of this research study is to find the answers to the following questions:

  1. What are the highest doses of CBP501 and cisplatin that can be safely administered as consecutive 2-hours and 1-hour infusions every 21 days?
  2. What are the side effects of the combination of CBP501 and cisplatin when given as an infusion every 21 days?
  3. What amount of CBP501 and cisplatin are found in the blood at certain times after it is given?
  4. Are there any substances in your blood or tumor that can tell us about tumor sensitivity to CBP501 and cisplatin?
  5. Will CBP501 given with cisplatin help to treat your cancer?
Read the detailed description

9.1 23BOverall Study Design and Plan This was an open-label, multicenter, dose-escalation and pharmacokinetic Phase I study of CBP501 and cisplatin administered as consecutive IV infusions according to a once-every-3-weeks schedule in patients with advanced solid tumors refractory to standard therapy. The study was conducted in three US centers. During the course of the study, an amendment was introduced (#3, October 17th, 2007; see section X9.8X) to allow administration of a unique dosing of single agent CBP501 prior to the initiation of combination therapy to enable completion of the pharmacokinetic (PK) characterization of single agent CBP501. Pharmacodynamic analysis involving phosphoserine 216 evaluations was also removed. See section X16.1.1X for copies of the protocol and all protocol amendments. With 8 additional patients included at the recommended dose (at DL6), it was decided to stop all PK and CTC sampling (and therefore the day-7 CBP501 alone infusion), as sufficient information had been retrieved. In addition, based on evidence of efficacy observed in ovarian cancer patients, a further 10 ovarian and 4 endometrial cancer patients were to be included at the recommended dose; these patients were to be assessed for DLT to confirm the identification of the MTD.

Case Report Forms were used to collect the data, and data management was carried out by AAIOncology. All laboratory data and Investigator observations were be transcribed into the CRF. ECG, U/S, MRI and CT scans were to be reported in summary in the CRF. The original reports, traces and films were to be retained by the Investigators for future reference. See section X16.1.2X for a sample CRF.

Conditions
Cancer, Solid Tumors
Being tested
CBP501 and Cisplatin
Keywords
cancer, solid tumors
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBP501 and CisplatinDrug

    Also called CBP501 and CDDP

    CBP501 is given IV on Day 1 of each cycle (every 21 days). Dose escalation of CBP501 and cisplatin will be starting doses of 3.6 mg/m² CBP501 and 50 mg/m² cisplatin (Dose Level 1). Step 1, if during the first 2 cycles, at least 2 out of 3 to 6 patients experience Dose Limiting Toxicity (DLT) at 50 mg/m² cisplatin, then the cisplatin dose will be de-escalated to 30 mg/m². If no more than 1 out of 6 patients experiences DLT, cisplatin dose will be escalated to 75 mg/m². Step 2, dose escalation will be performed using the cisplatin MTD, with escalating CBP501 doses. CBP501 dose escalation will take place until the MTD has been defined or 74 mg/m² is reached.

Study groups in NCT00551512
Study groupRoleWhat they receive
CBP501 and CisplatinExperimentalDose escalation study
Receives: Drug: CBP501 and Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicity (DLT) during the first two treatment cycles

    Measured: 6 weeks

Secondary outcomes (7)

  1. Incidence and severity of adverse events and laboratory abnormalities, graded according to NCI-CTCAE version 3.0

    Measured: During and at end of study

  2. Occurrence of Serious Adverse Events (SAEs)

    Measured: During and at end of study

  3. Occurrence of discontinuations due to treatment-related adverse events

    Measured: At end of study

  4. Serum concentrations of CBP501 and total and ultrafiltrate platinum to determine, via non-compartmental methods, Cmax, AUC, lz, t½, Cl and Vss.

    Measured: During and at end of study

  5. Evaluation of the relationship between administered dose and plasma pharmacokinetic parameters for CBP501 and cisplatin

    Measured: During and at end of study

  6. Objective tumor response assessed according to RECIST

    Measured: During and at end of study

  7. Time to progression

    Measured: During and at end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2007 (estimated)
  2. Study startNov 2006
  3. Primary completionMay 2009
  4. Study completionMay 2009

Resources

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00551512
Sponsor's protocol ID
CBP 06-01
Status last verified
Mar 2017
First submitted
29 Oct 2007
Last updated
14 Mar 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mine N, Yamamoto S, Saito N, Yamazaki S, Suda C, Ishigaki M, Kufe DW, Von Hoff DD, Kawabe T. CBP501-calmodulin binding contributes to sensitizing tumor cells to cisplatin and bleomycin. Mol Cancer Ther. 2011 Oct;10(10):1929-38. doi: 10.1158/1535-7163.MCT-10-1139. Epub 2011 Aug 10.

    PubMed 21831962

  • Sha SK, Sato T, Kobayashi H, Ishigaki M, Yamamoto S, Sato H, Takada A, Nakajyo S, Mochizuki Y, Friedman JM, Cheng FC, Okura T, Kimura R, Kufe DW, Vonhoff DD, Kawabe T. Cell cycle phenotype-based optimization of G2-abrogating peptides yields CBP501 with a unique mechanism of action at the G2 checkpoint. Mol Cancer Ther. 2007 Jan;6(1):147-53. doi: 10.1158/1535-7163.MCT-06-0371.

    PubMed 17237275

  • Suganuma M, Kawabe T, Hori H, Funabiki T, Okamoto T. Sensitization of cancer cells to DNA damage-induced cell death by specific cell cycle G2 checkpoint abrogation. Cancer Res. 1999 Dec 1;59(23):5887-91.

    PubMed 10606229

  • Matsumoto Y, Shindo Y, Takakusagi Y, Takakusagi K, Tsukuda S, Kusayanagi T, Sato H, Kawabe T, Sugawara F, Sakaguchi K. Screening of a library of T7 phage-displayed peptides identifies alphaC helix in 14-3-3 protein as a CBP501-binding site. Bioorg Med Chem. 2011 Dec 1;19(23):7049-56. doi: 10.1016/j.bmc.2011.10.004. Epub 2011 Oct 7.

    PubMed 22032894

  • Shapiro GI, Tibes R, Gordon MS, Wong BY, Eder JP, Borad MJ, Mendelson DS, Vogelzang NJ, Bastos BR, Weiss GJ, Fernandez C, Sutherland W, Sato H, Pierceall WE, Weaver D, Slough S, Wasserman E, Kufe DW, Von Hoff D, Kawabe T, Sharma S. Phase I studies of CBP501, a G2 checkpoint abrogator, as monotherapy and in combination with cisplatin in patients with advanced solid tumors. Clin Cancer Res. 2011 May 15;17(10):3431-42. doi: 10.1158/1078-0432.CCR-10-2345. Epub 2011 Jan 10.

    PubMed 21220472

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CBP501 and Cisplatin in people with Cancer and Solid Tumors, run by CanBas Co. Ltd. at 3 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 16 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 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Dose Limiting Toxicity (DLT) during the first two treatment cycles (time frame: 6 weeks). 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 NCT00551512, which also lists 5 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 14 Mar 2017.

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