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MalignanciesPhase 1NCT01407380

Study of PWT33597 Mesylate in Subjects With Advanced Malignancies

A Phase 1 study testing PWT33597 mesylate in people with Malignancies, run by Pathway Therapeutics, Inc. at 4 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

This is a Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and clinical effects of orally administered PWT33597 mesylate in subjects with advanced malignancies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignancies
What is being tested?
PWT33597 mesylate
Type of treatment
Pill or oral medicine
How many people
22 participants
Where
4 sitesUnited States
Study dates
Jun 2011to Sep 2012
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

  • Males and females ≥18 years of age.
  • Pathologically confirmed advanced solid tumor or malignant lymphoma for which standard therapy proven to provide clinical benefit does not exist or is no longer effective.
  • Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤1
  • Evaluable disease, either measurable on physical examination or imaging by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or by the criteria of the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, or by informative tumor marker(s).
  • Laboratory values at screening:
  • Absolute neutrophil count ≥1,500 /mm3;
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  • Platelets ≥100,000/mm3;
  • Total bilirubin ≤1.5 × the upper limit of normal (ULN);
  • AST (SGOT) ≤2.5 × the ULN;
  • ALT (SGPT) ≤2.5 × the ULN;
  • Serum creatinine ≤1.5 mg/dL or a measured creatinine clearance ≥60 mL/min; and
  • Negative serum beta-hCG test in women of childbearing potential (defined as women ≤50 years of age or history of amenorrhea for ≤12 months prior to study entry).
  • Patients with primary liver cancer or hepatic metastasis are eligible to enroll, provided that, at screening, the following criteria are met:
  • Total bilirubin is no higher than the ULN;
  • AST and ALT are each ≤5 × the ULN;
  • Severe liver dysfunction (Child-Pugh Class B or C) is not present; and
  • Patients with a history of esophageal bleeding have varices that have been sclerosed or banded and no bleeding episodes have occurred during the prior 6 months.
  • If there is a history of brain metastases treated with radiation therapy, the radiation therapy must have occurred at least 6 weeks prior to enrolment and the metastatic disease must have been stable since completion.
  • Willing and able to provide written Informed Consent and comply with the requirements of the study.
  • In addition, subjects enrolled in the Dose Confirmation Phase must meet the following criteria:
  • For subjects with solid tumors, measurable disease, using RECIST v1.1;
  • For subjects with malignant lymphoma, at least 1 lesion clearly measurable and >1.5cm transverse diameter in 2 perpendicular dimensions, per the criteria for International Working Group Revised Response Criteria for Malignant Lymphoma;
  • No prior treatment with an investigational PI3K, PI3K/mTOR, AKT or mTORC1/mTORC2 inhibitor (prior treatment with temsirolimus, everolimus, or ridaforolimus is allowed);
  • For subjects with colorectal cancer, evidence of lack of mutation in KRAS and BRAF, unless otherwise approved by the sponsor.
  • Tissue block or biopsy confirmation of PI3K alpha mutation on tumor genotyping.
  • Tumor accessible for pre- and post-treatment biopsy or cytology (in a subset of at least 5 subjects in each specific tumor type).

Who cannot join

  • Any chemotherapy, immunomodulatory drug therapy, anti-neoplastic hormonal therapy, immunosuppressive therapy, corticosteroids > 20 mg/day prednisone or equivalent (unless administered to prevent contrast material reactions during radiographic procedures), or growth factor treatment (eg, erythropoietin) within 14 days prior to initiation of study drug.
  • Presence of an acute or chronic toxicity of prior chemotherapy, with the exception of alopecia or peripheral neuropathy, that has not resolved to ≤ Grade 1, as determined by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v 4.0
  • Receipt of more than 5 prior regimens of cytotoxic chemotherapy unless prior approval is granted by the sponsor.
  • Radiotherapy within 4 weeks prior to baseline.
  • Receipt of radiotherapy to >25 % of bone marrow.
  • History of stem cell allotransplantation.
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  • Major surgery within 28 days prior to initiation of study drug.
  • Life expectancy <12 weeks.
  • Active infection requiring systemic therapy.
  • Insulin-requiring diabetes mellitus, or presence of persistent fasting blood glucose >160 mg/dL.
  • Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness.
  • Known active hepatitis B or C or other active liver disease (other than malignancy).
  • Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
  • History of or ongoing cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QTc (Fridericia) interval to > 450 msec for males or > 470 msec for females.
  • Previous malignancy, except for non-basal-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix, unless the tumor was treated with curative intent more than 2 years prior to study entry.
  • Concomitant treatment with, or anticipated use of, pharmaceutical or herbal agents which are potent inhibitors or inducers of cytochrome P450 3A4 enzymes, unless approved by the sponsor.
  • Use of any investigational agents within 4 weeks of baseline.
  • Pregnant or lactating female.
  • Women of childbearing potential, unless they agree to use dual contraceptive methods which, in the opinion of the Principal Investigator, are effective and adequate for that patient's circumstances while on study drug and for 3 months afterward.
  • Men who partner with a woman of childbearing potential, unless they agree to use effective, dual contraceptive methods (ie, a condom, with female partner using oral, injectable, or barrier method) while on study drug and for 3 months afterward.
  • Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of study results and, in the investigator's opinion, would make the patient inappropriate for entry into this study.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Pinnacle Hematology Oncology

    Scottsdale, Arizona, 85258

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85719

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of Orally Administered PWT33597 Mesylate in Subjects With Advanced Malignancies

This is a Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and clinical effects of orally administered PWT33597 mesylate in subjects with advanced malignancies.

Read the detailed description

This is a multicenter, open-label, non-randomized, dose-escalation study, to be conducted in 2 phases. The Dose Escalation Phase (up to 36 patients) will determine the MTD of PWT33597 mesylate and evaluate its safety and tolerability, PK, PD, and preliminary clinical effects; the subsequent Dose Confirmation Phase (up to 36 patients) will be a cohort expansion at or below the MTD of PWT33597 mesylate. Subjects will be treated with once-daily oral doses of PWT33597 in consecutive, 28-day cycles. Subjects will be evaluated regularly for safety. Subjects will return for a follow-up visit 28 days after completion of the last dose of study drug. Subjects who tolerate the drug and who do not experience progressive disease may continue to receive PWT33597 mesylate at the discretion of the principal investigator for up to 24 cycles

Conditions
Malignancies
Being tested
PWT33597 mesylate
Keywords
Advanced malignancies, solid tumors, cancer
Medical subject headings
Neoplasms

What participants receive

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

  • PWT33597 mesylateDrug

    PWT33597 taken orally daily for 28 consecutive days in 28 day cycle

What is being measured

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

  1. Number of patients with adverse events

    Measured: 2 years

Secondary outcomes (1)

  1. Number of patients whose tumor show objective response or stable disease by standard criteria

    Measured: 2 years

Timeline

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

  1. First posted2 Aug 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionAug 2012
  4. Study completionSep 2012

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01407380
Sponsor's protocol ID
PWT33597-101
Status last verified
Oct 2012
First submitted
21 Jul 2011
Last updated
25 Oct 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PWT33597 mesylate in people with Malignancies, run by Pathway Therapeutics, Inc. 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 26 inclusion and 21 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 25 Oct 2012. 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?

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?

Number of patients with adverse events (time frame: 2 years). 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 NCT01407380.

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 25 Oct 2012.

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