Phase 2
N=41
Study With IMC-A12 (Cixutumumab) in Patients Who Have Not Previously Been Treated With Chemotherapy With Metastatic Prostate Cancer
Adenocarcinoma of the Prostate
Bottom Line
View on ClinicalTrials.gov: NCT00520481 ↗Enrolled (actual)
41
Serious AEs
14.6%
Results posted
Jul 2018
Primary outcome: Primary: Composite Time to Disease Progression (cTTP) for Participants Treated With Cixutumumab — 4.9; 3.2 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IMC-A12 (Cixutumumab) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Time to Disease Progression (cTTP) for Participants Treated With Cixutumumab |
4.9; 3.2 | — |
| PRIMARY Area Under the Curve (AUC) of IMC-A12 Administered at a Dose of 20 mg/kg Every 3 Weeks |
— | — |
| PRIMARY Maximum Concentration (Cmax) of IMC-A12 Administered at a Dose of 20 mg/kg Every 3 Weeks |
993; 1780 | — |
| SECONDARY Number of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) |
28; 10; 6; 0; 1; 0 | — |
| SECONDARY Time to Radiographically Evident Disease Progression |
4.8; 3.3 | — |
| SECONDARY Number of Participants With Complete Response (CR) or Partial Response (PR) (Tumor Response Rate) |
0; 0 | — |
| SECONDARY Percentage of Participants With Prostate Specific Antigen (PSA) Response Rate |
1.0; 0.0 | — |
| SECONDARY Progression-Free Survival (PFS) Rate at 6 Months |
41.1; 40.0 | — |
| SECONDARY Area Under the Curve (AUC) of IMC-A12 Administered at a Dose of 10 mg/kg Every 2 Weeks |
— | — |
| SECONDARY Maximum Concentration (Cmax) of IMC-A12 Administered at a Dose of 10 mg/kg Every 2 Weeks |
NA | — |
Summary
This single arm, multicenter, open-label, Phase II study will enroll chemotherapy-naive participants with metastatic, histologically-confirmed adenocarcinoma of the prostate (stage M1 D2). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Non-surgically castrated participants must continue the use of luteinizing hormone-releasing hormone (LHRH) agonists during protocol treatment.
Eligibility Criteria
Inclusion Criteria
- The participant is male and at least 18 years of age
- The participant has histologically-confirmed adenocarcinoma of the prostate
- The participant has radiographic evidence of metastatic prostate cancer (stage M1 [D2])
- The participant has prostate cancer unresponsive or refractory to hormone therapy
- The participant must have evidence of progressive disease defined as at least one of the following:
- a. Progressive measurable disease: using conventional solid tumor criteria.
- b. Bone scan progression: at least one new lesion on bone scan.
- c. Increasing prostate specific antigen (PSA): at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2
- The participant has a PSA ≥ 2 nanograms/milliliter (ng/mL)
- The participant has not received prior chemotherapy for metastatic prostate cancer
- The participant had prior surgical or medical castration with a serum testosterone level of 60 milliliter/minute (mL/min); and urine protein ≤ 1+ (if urine protein is ≥ 2+, a 24-hour urine collection must demonstrate 6 months
- The participant, if sexually active, agrees to use contraceptives while on study
- The participant has provided signed informed consent
Exclusion Criteria
- The participant has any active malignancy (other than adequately treated nonmelanomatous skin cancer or other noninvasive or in situ neoplasms), or has an adequately-treated prior cancer but has been disease free for 30% of the bone marrow or prior strontium-89, rhenium-186, rhenium-188, or samarium-153 (participants who have received standard dose radiation to the pelvis for prostate cancer and no additional radiotherapy are eligible)
- The participant has a known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
- The participant has received more than one course of radiotherapy to a single site of metastatic bony disease
- The participant has a bone scan that indicates "superscan" (that is (ie), extensive metastasis to bone in numerous areas, too numerous to count or define)
- The participant is receiving corticosteroids (dexamethasone, prednisone, or others) for anorexia, weight loss, analgesia or other cancer-related symptoms(Corticosteroids may not be instituted once a participant has begun therapy on-study
- The participant requires ongoing, regularly scheduled opiate analgesic therapy for cancer related pain. Intermittent, infrequent low-potency opiate-use (example, oxycodone, codeine) is permitted
- The participant has a history of prior treatment with other agents that specifically target the insulin-like growth factor (IGF) receptor
Data sourced from ClinicalTrials.gov (NCT00520481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.