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Advanced Solid TumorsPhase 1NCT00891280

Dose-escalation Study of Oral CX-4945

A Phase 1 study testing CX-4945 oral formulation in people with Advanced Solid Tumors and Breast Cancer, run by Cylene Pharmaceuticals at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability and highest safe dose level of this CK2 inhibitor in patients with advanced solid tumor cancers, Castleman's Disease or Multiple Myeloma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CX-4945 oral formulation
Type of treatment
Pill or oral medicine
How many people
55 participants
Where
4 sitesUnited States
Study dates
Feb 2009to Dec 2011
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 malignancy or lymphoproliferative disorder known to over express CK2 which has failed standard therapies (surgery, radiotherapy, endocrine therapy, chemotherapy) or for which effective therapy is not available, including the following types: (examples)
  • Lung cancer
  • Renal cell cancer
  • Breast cancer
  • Inflammatory breast cancer
  • Head and neck cancer - squamous cell
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  • Prostate cancer
  • Colorectal cancer
  • Castleman's disease (multi-centric disease)
  • Multiple myeloma (Eligible patients must have quantifiable M-protein levels present in serum and/or urine)
  • At least 18 years of age.
  • One or more tumors measurable on radiograph or CT scan, or evaluable disease defined as non-measurable lesions per RECIST or detection of protein M in serum and/or urine of patients with Multiple Myeloma (serum ≥ 10 gm/L and urine ≥ 200 mg/24 hr).
  • Laboratory data as specified below:
  • Hematology: ANC >1500 cells/mm3, platelet count >100,000 cells/mm3 and Hemoglobin > 9 gm/L
  • Hepatic: bilirubin <1.5 X ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 X ULN. Patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5.0 X ULN
  • Renal: serum creatinine within normal limits (WNL), defined as within 10% of the institution's stated reference range, or a calculated creatinine clearance >60 mL/min/1.73 m2 for patients with abnormal, increased, creatinine levels. Patients with Multiple Myeloma (only): serum creatinine ≤ 2.5 the institutional upper limit of the normal range and a calculated creatinine clearance > 40 mL/min/1.73 m2.
  • Coagulation: INR < 1.5 times normal, aPTT < 1.5 times normal. Patients receiving therapeutic doses of anticoagulant therapy may be considered eligible for the trial if INR and aPTT are within the acceptable therapeutic limits for the institution.
  • A negative pregnancy test (if female of childbearing potential).
  • Estimated life expectancy of at least 3 months
  • Karnofsky Performance Status ≥ 70%
  • For men and women of child-producing potential, use of effective contraceptive methods during the study
  • Ability to understand the requirements of the study, provide written informed consent.

Who cannot join

  • Pregnant or nursing women.
  • Seizure disorders requiring anticonvulsant therapy.
  • Known brain metastases (unless previously treated and well controlled for a period of > or = 3 months).
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to the first dose of test drug.
  • Treatment with radiation therapy or surgery within one month prior to study entry
  • Treatment with chemotherapy or investigational drugs within 21 days prior to the screening visit. Acute toxicities from prior therapy must have resolved to Grade ≤ 1 above baseline.
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  • Patients with a history of a second malignancy within 3 years of the baseline visit excluding cutaneous carcinomas and in-situ carcinoma.
  • Concurrent severe or uncontrolled medical disease.
  • Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral hepatitis.
  • Difficulty with swallowing or an active malabsorption syndrome
  • Chronic diarrhea
  • Gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis
  • History of gastric or small bowel surgery involving any extent of gastric or small bowel resection.
  • Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis
  • Patients who have exhibited allergic reactions to a similar structural compound or to a formulation component.
  • Concomitant use of warfarin and HMG-CoA reductase inhibitors (statins)

Trial locations and contacts

4 sites in 1 country.

United States4 sites, 4 recruiting

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

    P. Zeller, 970-212-7609

    Robert F Marschke, MD

    Recruiting

  • U T M D Anderson Cancer Center

    Houston, Texas, 77030

    R. Alvarez, MD, ralvarez@mdanderson.org

    R. Alvarez, MD

    Recruiting

  • Front Range Cancer Specialists

    Loveland, Colorado, 80528

    Pat Zeller, 970-212-7609

    R. McFarland, MD

    Recruiting

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

    Clinical Trials Office Mayo Clinic Cancer Center, 507-538-7623

    Donald Northfelt, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CX-4945 Administered Orally to Patients With Advanced Solid Tumors, Castleman's Disease or Multiple Myeloma

This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability and highest safe dose level of this CK2 inhibitor in patients with advanced solid tumor cancers, Castleman's Disease or Multiple Myeloma.

Read the detailed description

Elevated CK2 activity has been associated with malignant transformation and aggressive tumor growth and overexpression of CK2 has been documented in multiple types of cancer. CK2 has emerged as a potential anticancer target and inhibition of CK2 represents a potential therapeutic strategy to target a specific molecular defect perpetuating many cancers. CX-4945 has demonstrated potent inhibition of CK2 enzymatic activity. This study will evaluate the safety, pharmacokinetics (PK), and pharmacodynamic (PD) effects of CX-4945 administered to patients with malignancies or lymphoproliferative disorders known to overexpress CK2 including advanced solid tumors, Multiple Myeloma and Castleman's Disease.

Being tested
CX-4945 oral formulation
Keywords
Inflammatory breast cancer, Castleman's Disease, Multiple Myeloma, Breast cancer, Solid tumors, CK2 inhibitor
Medical subject headings
Breast Neoplasms, Inflammatory Breast Neoplasms, Castleman Disease, Multiple Myeloma

What participants receive

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

  • CX-4945 oral formulationDrug

    CX-4945 Capsules, Oral, Dose escalation study, Dose schedule: twice daily or four times daily for 21 consecutive days every 28 days.

What is being measured

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

  1. Safety (Dose limiting toxicities, maximum tolerated dose)

    Measured: One year (Assessed at Cycle 1)

  2. Drug-related adverse events

    Measured: One Year (Asessed from first administration of study drug through 30 days after the last dose)

Secondary outcomes (3)

  1. Pharmacokinetic and pharmacodynamic assessments

    Measured: One Year (Assessed during Cycle 1)

  2. Observe evidence of antitumor activity

    Measured: One Year (Assessed after every two cycles)

  3. Establish the recommended Phase 2 dose

    Measured: One Year (Study completion)

Timeline

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

  1. First posted1 May 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionDec 2011 (estimated)
  4. Study completionDec 2011 (estimated)

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00891280
Sponsor's protocol ID
C4-08-001
Status last verified
Jun 2011
First submitted
29 Apr 2009
Last updated
15 Jun 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CX-4945 oral formulation in people with Advanced Solid Tumors and Breast Cancer, run by Cylene Pharmaceuticals at 4 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 22 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 15 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (Dose limiting toxicities, maximum tolerated dose) (time frame: One year (Assessed at Cycle 1)). The study lists 2 primary outcomes in all. 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 NCT00891280.

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 Jun 2011.

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