CClinicalTrials.gg
Sign In
WithdrawnNCT03123744Updated Jun 21, 2018

Histology-Independent Study of Palbociclib in Patients With Advanced Cancer

A Phase 2 interventional study of Palbociclib 125mg in Cancer, Advanced, sponsored by Razelle Kurzrock, MD. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-21.

Sponsored by Razelle Kurzrock, MD · Phase 2, Interventional, and Treatment

Why this study was withdrawn
No study funding available.
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The investigational drug being tested in this study is palbociclib. Palbociclib is considered experimental because it is not approved by the FDA for the treatment of all cancers. Palbociclib is currently approved for use in breast cancer. Palbociclib is a drug belonging to a family of drugs called kinase inhibitors. These drugs slow or stop the activity of particular proteins involved in the growth of human cells and in the abnormal growth of cancer cells. Blocking these proteins may decrease or stop tumor growth. The purpose of this study is to assess the safety of the study drug, to see how well it is tolerated, and also to find a safe dose range of the study drug in patients with specific kinds of tumor genetic changes.

Read the detailed description

This study proposes to give the cyclin dependent kinase (CDK) inhibitor palbociclib to patients with advanced malignancy harboring cyclin pathway aberrations (CCN/CDK alterations). The investigators study will determine whether cyclin signaling aberrations associate with response to this CDK inhibitor. Once completed, this study will identify subpopulations of patients that would best benefit from CDK inhibitor therapy with palbociclib and suggest directions for future study.

02

Conditions studied

  • Cancer, Advanced

Keywords

  • Palbociclib
  • Cyclin Pathway
  • kinase inhibitor
03

In context

Lead sponsor

This is the only study on the registry with Razelle Kurzrock, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 18 years old

  2. Pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:

    • Subject is intolerant to standard therapy
    • Subject refuses standard therapy
    • Malignancy is refractory to standard therapy
    • Malignancy relapsed after standard therapy
    • Malignancy for which there is no standard therapy that improves survival by at least 3 months.
  3. Evaluable tumor(s) with documented alteration(s) in CCN/CDK-related gene(s). The CCN/CDK aberration(s) can be identified at any point in the subject's cancer course. CCN/CDK testing must have been performed in a CLIA-certified laboratory. Amplification(s) and/or mutation frequencies will be defined according to the standard of the test used.
  4. ECOG Performance Status 0-2
  5. Women of childbearing potential must have a negative baseline blood pregnancy test. Women and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study and for at least 30 days after discontinuation of study drug (the half life of palbociclib is about 27 hours in patients with cancer).
  6. Subjects must be off other anti-tumor agents for at least 5 half lives of the agent or 4 weeks from the last day of treatment, whichever is shorter. Endocrine therapies (for example for breast or prostate cancer) and anti-Her2 therapies (for example, trastuzumab or lapatinib) are allowed to continue while on this study.
  7. Subjects may not be receiving any other experimental agents.
  8. Ability to understand and willingness to sign a written consent document.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. Subjects who have not recovered from toxicities as a result of prior anticancer therapy, except alopecia and infertility. Recovery is defined as \< Grade 2 severity per Common Terminology Criteria for Adverse Events Version 4.0(1) (CTCAE v4.0) or to their clinical baseline.
  3. Inability to swallow pills or determination by the investigator that absorption of oral medication would be impaired.
  4. Major surgery (not including placement of central lines) within 3 weeks prior to trial enrollment or planned surgery during the course of this study.
  5. Any medical condition which, in the opinion of the investigator, would preclude study participation
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Palbociclib 125 mg

    Palbociclib is administered orally at a starting dose of 125 mg/day for three weeks followed by one week off. Study measurements will be obtained at baseline and about every 8 weeks thereafter. Subjects will continue study drug until disease progression or unacceptable toxicity.

    Drug: Palbociclib 125mg

Interventions

  • DrugPalbociclib 125mg

    Palbociclib 125 mg is administered orally at a starting dose of 125 mg/day for three weeks followed by one week off. Study evaluations include physical exams, performance status, vital signs, laboratory blood tests, and radiographic or MRI imaging.

    Also known as: Ibrance®

06

What researchers measure

Primary outcomes

  1. Response rates in subjects with advanced cancer and aberrations of cyclin pathway gene(s) who are treated with palbociclib

    Radiographic or MRI imaging will be assessed approximately every 8 weeks for disease progression.

    Time frame: Every 8 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Complete physical exams will be assessed every 2 to 4 weeks during treatment to evaluate the number of patients with a drug toxicity and disease progression.

    Time frame: Every 2-4 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.

  2. Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

    Laboratory blood tests will be assessed every 2 to 4 weeks during treatment to evaluate the number of patients for drug toxicity and disease progression.

    Time frame: Every 2-4 weeks from date of enrollment, assessed up to 36 months.

07

Study locations

1 site
  • UCSD Moores Cancer Center
    La Jolla, California 92093, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03123744
Lead sponsor
Razelle Kurzrock, MD
Responsible party
Razelle Kurzrock, MD (Professor of Medicine, University of California, San Diego) — Sponsor-investigator
First posted
Apr 21, 2017
Start date
Jul 1, 2018 (estimated)
Primary completion
Feb 1, 2020 (estimated)
Completion
Feb 1, 2024 (estimated)
Last update
Jun 21, 2018

Study contacts

Scott Lippman, MD
study director · UCSD

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion