PD-0325901 for Tumors, Solid

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dana Farber Cancer Institute, Boston, MA
Tumors, Solid+3 More
PD-0325901 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a drug called palbociclib can be used to treat lung cancer.

See full description

Eligible Conditions

  • Tumors, Solid
  • KRAS Mutant Non-Small Cell Lung Cancer

Treatment Effectiveness

Study Objectives

This trial is evaluating whether PD-0325901 will improve 2 primary outcomes and 3 secondary outcomes in patients with Tumors, Solid. Measurement will happen over the course of 2 Years.

2 Years
Overall Response Rate
Pharmacokinetics
Safety and tolerability
Target engagement of palbociclib and PD-0325901
2 years
Maximum Tolerated Dose and Recommended Phase 2 Dose

Trial Safety

Trial Design

1 Treatment Group

Palbociclib and PD-0325901
1 of 1
Experimental Treatment

This trial requires 139 total participants across 1 different treatment group

This trial involves a single treatment. PD-0325901 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Palbociclib and PD-0325901Palbociclib by mouth once a day, every day for 3 weeks every 4 in each cycle. PD-0325901 by mouth twice a day, every day for 3 weeks every 4 in each cycle. .
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
FDA approved
PD-0325901
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Who is running the study

Principal Investigator
G. S.
Geoffrey Shapiro,, MD PhD
Dana-Farber Cancer Institute

Closest Location

Dana Farber Cancer Institute - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Dose-escalation/MTD cohorts, participants must have histologically confirmed malignancy with a RAS mutation that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. For the randomized phase 2 component of the study, participants must have histologically confirmed NSCLC with a confirmed KRAS mutation (via any CLIA-certified method)
For the dose-escalation component, participants are required to have only evaluable disease. For the MTD cohort and phase 2 component of the study, participants must have measurable disease.
Participants enrolled to the MTD cohort must agree to pre and on-treatment tumor biopsies if assessable disease is identified.
Age ≥18 years.
ECOG performance status ≤ 2 (see Appendix A).
Absolute neutrophils 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 (≤ 5.0 X institutional upper limit of normal permitted if hepatic metastases present)
Creatinine within 1.5x the ULN institutional limits.

Patient Q&A Section

Can carcinoma, non-small-cell lung be cured?

"curative treatment of carcinoma, non-small-cell lung is possible. However, curative treatment would often be only palliative. More information on prognostic factors and better treatment of lung cancer have to be investigated in the future." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, non-small-cell lung?

"The overall rate of bronchiolar carcinoma is 15.3% in males, and 15.0% in females older than fifty years. Carcinoma diagnosed later were associated with low risk of mortality from lung cancer. Age and chronic obstructive pulmonary disease (COPD) were independent risk factors for bronchiolar carcinoma. Carcinoma, non-small-cell lung, was the most common form of lung cancer." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma, non-small-cell lung a year in the United States?

"The incidence of all lung cancer and NSCLC in the USA remains relatively static over time. Although the overall trend has remained upward over the past 4 decades, there was no apparent trend during the last 8-10 years (1983-1991). The highest incidence rate of all malignant respiratory diseases was observed in African Americans of all age groups. The incidence of all malignant respiratory diseases remains highest in people younger than 40 years, and there was no apparent trend over time (1983-1991). The highest incidence rate of NSCLC is observed in non-Hispanic whites and African Americans of all age groups; age at time of diagnosis was positively associated with survival in all groups." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, non-small-cell lung?

"The prevalence of various environmental and behavioral risk factors increases with age, particularly among men. However, the overall age-adjusted prevalence of specific risk factors was less than expected among age groups younger than 75 years." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, non-small-cell lung?

"As with non-cancerous lesions, cancer treatment depends on the extent of disease and is dependent on how advanced the tumor is. If the tumor responds to surgery, then adjuvant therapy is often prescribed. If the tumor is unresectable, then chemotherapy and/or radiation can be used to delay or prevent the progression of the disease. If the tumor responds to either adjuvant therapy or surgery, then postoperative radiation may be recommended. If there is no response to either adjuvant therapy or surgery, then definitive therapy with radiation or chemotherapy alone is commonly prescribed." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma, non-small-cell lung?

"A patient with lung cancer need to consult their doctor regularly, and those with symptoms need to consult other physicians in their region. We need to educate the general public on smoking and smoking habits, on lung cancer and its signs, and on lung cancer prevention." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of pd-0325901?

"Pd-0325901 has been used at doses up to 1200 mg twice per day for various indications in a clinical context, without severe adverse effects at either dose. Although uncommon at those dosages, the side effects observed in this study are consistent with the clinical experience with pd-0325901 as a biopharmaceutical." - Anonymous Online Contributor

Unverified Answer

What is the latest research for carcinoma, non-small-cell lung?

"The treatment for NSCLC seems to be more individualized. In particular, some clinical trial trials have shown a better survival from adjuvant chemotherapy in female participants. For example, the NCCTG phase III study showed more patients in which platinum-based chemotherapy was the treatment compared with nonplatinum-based chemotherapy. Findings from a recent study will help clinicians to counsel patients and decide whether to start adjuvant chemotherapy. As some important patients for adjuvant chemotherapy would not be eligible for some clinical trials, it is mandatory to carry out more individualized studies. In addition, more prospective clinical studies are required to show the effect of therapy in NSCLC according to the stage of disease." - Anonymous Online Contributor

Unverified Answer

How serious can carcinoma, non-small-cell lung be?

"This paper illustrates the incidence of cancer in the population of Buenos Aires, Argentina, and discusses factors related to this morbidity. The study shows that the disease-free survival rate of patients suffering from pulmonary carcinoma is extremely low in the first six months and only increases a bit over the following years." - Anonymous Online Contributor

Unverified Answer

What is pd-0325901?

"Pd-0325901 is a potent CDK2 kinase inhibitor with antiproliferative activity in human cancer and preclinical murine tumors. Pd-0325901 might have a potential as a target for novel treatments in many solid tumor entities that have been shown to display overexpression of CDK2, including colon, ovarian, breast, and lung." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets carcinoma, non-small-cell lung?

"For the first time, a representative series of carcinoma cases reported in the literature was reviewed, with an average age of 69 +/- 11.4 yr for both genders. The average age of carcinomas, other than lung adenocarcinoma, is much higher than that of other solid adenocarcinomas reported in the literature." - Anonymous Online Contributor

Unverified Answer

Is pd-0325901 typically used in combination with any other treatments?

"Results from a recent paper suggests that PD-0332598 is most commonly and routinely used in combination with most other chemotherapies; therefore, it is important to study the most frequently used pd-0332598 combinations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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