NCT02152254

Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT II)

Active, enrolled Phase 2 Last updated 17 February 2026

What this trial tests

Phase 2 trial testing Targeted Therapy Based on Molecular Profiling in Metastatic Malignant Neoplasm in 1,362 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 May 2014

Primary endpoint
31 December 2030

31 December 2030

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,362
Start date	13 May 2014
Primary completion	31 December 2030
Estimated completion	31 December 2030
Sites	1 location across United States

Drugs / interventions tested

• Targeted Therapy Based on Molecular Profiling — full drug profile →
• Standard-of-Care Therapy

Conditions studied

• Metastatic Malignant Neoplasm — all drugs for Metastatic Malignant Neoplasm →
• Recurrent Malignant Neoplasm — all drugs for Recurrent Malignant Neoplasm →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Metastatic Malignant Neoplasm or Recurrent Malignant Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This randomized clinical trial studies how molecular profiling and targeted therapy work in treating patients with cancer that has spread to other places in the body compared to standard treatment. Information about genetic differences in a patient's tumor can be used to choose treatment that may target the tumor. It is not yet validated whether selecting treatment after studying the genetic changes that are associated with cancer in a patient's tumor is a better way to treat patients with metastatic cancer compared to therapy not based on studying the genetic changes that are associated with cancer.

Publications & conference data

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

1. Review of precision cancer medicine: Evolution of the treatment paradigm.
   Tsimberidou AM, Fountzilas E, Nikanjam M, Kurzrock R. · · 2020 · cited 475× · PMID 32251926 · DOI 10.1016/j.ctrv.2020.102019
2. Clinical trial design in the era of precision medicine.
   Fountzilas E, Tsimberidou AM, Vo HH, Kurzrock R. · · 2022 · cited 180× · PMID 36045401 · DOI 10.1186/s13073-022-01102-1
3. Targeted therapy in cancer.
   Tsimberidou AM. · · 2015 · cited 156× · PMID 26391154 · DOI 10.1007/s00280-015-2861-1
4. An overview of precision oncology basket and umbrella trials for clinicians.
   Park JJH, Hsu G, Siden EG, Thorlund K, et al · · 2020 · cited 144× · PMID 32031692 · DOI 10.3322/caac.21600
5. Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT): An MD Anderson Precision Medicine Study.
   Tsimberidou AM, Hong DS, Ye Y, Cartwright C, et al · · 2017 · cited 119× · PMID 29082359 · DOI 10.1200/po.17.00002
6. Disease activity states of the DAPSA, a psoriatic arthritis specific instrument, are valid against functional status and structural progression.
   Aletaha D, Alasti F, Smolen JS. · · 2017 · cited 59× · PMID 27457512 · DOI 10.1136/annrheumdis-2016-209511
7. Long-term overall survival and prognostic score predicting survival: the IMPACT study in precision medicine.
   Tsimberidou AM, Hong DS, Wheler JJ, Falchook GS, et al · · 2019 · cited 54× · PMID 31888672 · DOI 10.1186/s13045-019-0835-1
8. Next-Generation Sequencing to Guide Clinical Trials.
   Siu LL, Conley BA, Boerner S, LoRusso PM. · · 2015 · cited 51× · PMID 26473189 · DOI 10.1158/1078-0432.ccr-14-3215