18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Lapatinib Maximum Tolerated Dose (MTD) [Phase I]Primary· The evaluation for MTD occurred continuously through one cycle of KHLAD treatment (28 days).
The MTD of lapatinib in combination with KHAD is determined by the number of participants who experience a dose limiting toxicity (DLT) at the various dose levels of lapatinib under evaluation. See subsequent primary outcome measure for the DLT definition. The MTD is defined as the lapatinib dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached and the Recommended Phase II Dose (RP2D) will be based on safety and pharmacokinetic results.
Group
Value
95% CI
All Phase I Participants KHAD+L
NA
Lapatinib Dose Limiting Toxicity (DLT) [Phase I]Primary· The evaluation for DLT occurred continuously through one cycle of treatment (28 days).
A DLT is defined as an adverse event (AE) occurring during the first cycle of KHLAD treatment that are determined to related to the Lapatinib or the combination as follows:
1. Any Grade 3 or greater non-hematological treatment related (possible, probable, or definite attribution) including diarrhea
2. Grade 4 or greater for hematological toxicities, regardless of attribution.
3. Grade 3 skin reactions, pulmonary reactions, regardless of attribution.
Group
Value
95% CI
Phase I Dose Level 1: KHAD+L (250 mg)
0
Phase I Dose Level 2: KHAD+L (500 mg)
2
Plasma Lapatinib Levels [Phase I]Primary· After first 28 days of KHLAD treatment
Plasma lapatinib levels were measured after day 28 of KHLAD treatment. Participants were instructed to fast prior to samples being taken.
Group
Value
95% CI
Phase I Dose Level 1: KHAD+L (250 mg)
731
416 – 1424
Phase I Dose Level 2: KHAD+L (500 mg)
1506
680 – 2186
Grade 3-4 Treatment-Related Adverse Events RateSecondary· Assessed each cycle throughout treatment. Treatment duration in months was a median (range) of 5.4 months (range 1 day-8.3 months). Thus, AEs were evaluated up to 8.3 months.
All grade 3-4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted to calculate the proportion of participants experiencing at least one treatment-related grade 3 or 4 AE of any type on treatment.
Group
Value
95% CI
Phase I Dose Level 1: KHAD+L (250 mg)
0
0.0 – 0.451
Phase I Dose Level 2: KHAD+L (500 mg)
0.40
0.076 – 0.811
Adverse events — posted to ClinicalTrials.gov
Time frame: Assessed each cycle throughout treatment. Median (range) treatment duration (months) for dose level 1: 5.5 (1.8-8.3) and dose level 2: 5.4 (0.2-17.9). Thus, AEs were followed up to 17.9 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this research study is to determine the safety of giving ketoconazole, hydrocortisone and dutasteride (KHAD) with lapatinib. Safety is primarily based on dose limiting toxicity (DLT) evaluation at various dose levels (DL). The investigators believe that there is evidence in castrate resistant prostate cancer (CRPC) that two growth factor receptors (EGFR and Her 2/Neu) are increased in prostate cancer (PCa) cells. Both these receptors are turned off by the drug lapatinib. By adding lapatinib, the investigators hope that signaling from the receptors will be turned off and therefore make the participant's cancer more responsive to KHAD treatment.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01802931 — GSK239512 DDI Study
· Phase 1
· completed
NCT01165125 — A Drug Interaction Study With Fluticasone Furoate/GW642444 Inhalation Powder and Ketoconazole
· Phase 1
· completed
NCT00404378 — Study Of Healthy Subjects To Assess The Effect Of Ketoconazole And The Way The Body Will React To Casopitant [GW679769]
· Phase 1
· completed
NCT00460031 — Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
· Phase 2
· completed
Other recruiting trials for Prostate Cancer
Currently open trials in the same condition.
NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno)
· recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer
· Phase 2
· recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer
· Phase 2
· recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris
· Phase 2
· recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate
· Phase 2, PHASE3
· recruiting
Other Dana-Farber Cancer Institute trials
Trials by the same sponsor.
NCT07519200 — Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention
· NA
· not yet recruiting
NCT07499999 — Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk fo
· Phase 2
· not yet recruiting
NCT05825469 — Development and Testing of Nutritional Algorithms (NACHO)
· NA
· not yet recruiting
NCT07516353 — my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
· NA
· not yet recruiting
NCT07513324 — Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0)
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dana-Farber Cancer Institute
Last refreshed: 4 September 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00953576.