NCT02897375

Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors

Completed Phase 1 Last updated 10 October 2023

What this trial tests

Phase 1 trial testing Carboplatin in Solid Neoplasm in 71 participants. Completed in 15 October 2021.

Timeline

24 October 2016

Primary endpoint
15 October 2021

15 October 2021

Quick facts

Lead sponsor	Emory University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	71
Start date	24 October 2016
Primary completion	15 October 2021
Estimated completion	15 October 2021
Sites	1 location across United States

Drugs / interventions tested

• Carboplatin (Carboplatin) — full drug profile →
• Cisplatin (cisplatin) — full drug profile →
• Palbociclib (Palbociclib) — full drug profile →

Conditions studied

• Solid Neoplasm — all drugs for Solid Neoplasm →
• Stage III Pancreatic Cancer — all drugs for Stage III Pancreatic Cancer →
• Stage IIIA Breast Cancer — all drugs for Stage IIIA Breast Cancer →
• Stage IIIA Non-Small Cell Lung Cancer — all drugs for Stage IIIA Non-Small Cell Lung Cancer →

Sponsor

Emory University

Who can join

18 and older, any sex, with Solid Neoplasm or Stage III Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and best dose of palbociclib with cisplatin or carboplatin in treating patients with solid tumors that have spread to other places and usually cannot be cured or controlled with treatment. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib with cisplatin or carboplatin may help stop tumor growth in patients with advanced solid tumors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. CDK4/6 Inhibitors: The Mechanism of Action May Not Be as Simple as Once Thought.
   Klein ME, Kovatcheva M, Davis LE, Tap WD, et al · · 2018 · cited 308× · PMID 29731395 · DOI 10.1016/j.ccell.2018.03.023
2. The Strange Case of CDK4/6 Inhibitors: Mechanisms, Resistance, and Combination Strategies.
   Knudsen ES, Witkiewicz AK. · · 2017 · cited 218× · PMID 28303264 · DOI 10.1016/j.trecan.2016.11.006
3. Development of Chemotherapy with Cell-Cycle Inhibitors for Adult and Pediatric Cancer Therapy.
   Mills CC, Kolb EA, Sampson VB. · · 2018 · cited 110× · PMID 29311160 · DOI 10.1158/0008-5472.can-17-2782
4. Targeting DNA Damage Response and Repair to Enhance Therapeutic Index in Cisplatin-Based Cancer Treatment.
   Kiss RC, Xia F, Acklin S. · · 2021 · cited 90× · PMID 34360968 · DOI 10.3390/ijms22158199
5. Aneuploidy increases resistance to chemotherapeutics by antagonizing cell division.
   Replogle JM, Zhou W, Amaro AE, McFarland JM, et al · · 2020 · cited 77× · PMID 33203674 · DOI 10.1073/pnas.2009506117
6. Molecular mechanisms underpinning sarcomas and implications for current and future therapy.
   Damerell V, Pepper MS, Prince S. · · 2021 · cited 75× · PMID 34188019 · DOI 10.1038/s41392-021-00647-8
7. The Emerging Role of Cyclin-Dependent Kinases (CDKs) in Pancreatic Ductal Adenocarcinoma.
   García-Reyes B, Kretz AL, Ruff JP, von Karstedt S, et al · · 2018 · cited 54× · PMID 30340359 · DOI 10.3390/ijms19103219
8. Chemotherapy and CDK4/6 Inhibitors: Unexpected Bedfellows.
   Roberts PJ, Kumarasamy V, Witkiewicz AK, Knudsen ES. · · 2020 · cited 48× · PMID 32546660 · DOI 10.1158/1535-7163.mct-18-1161