A Phase I Trial and Pharmacokinetic Study of the Oral Platinum Analog Satraplatin in Children and Young Adults With Refractory Solid Tumors Including Brain Tumors

Background:
Cisplatin and carboplatin are standard cancer treatment drugs used for various childhood cancers, including brain tumors. Both drugs frequently have severe side effects that may reduce their effectiveness, particularly in children, and new treatments are needed that may be similarly effective but less toxic for cancer patients.
Satraplatin is an experimental drug, similar to cisplatin and carboplatin, that has not yet been approved by the Food and Drug Administration. Satraplatin has been shown to treat cancer by interfering with genetic material (DNA) in cancer cells. Some adults with cancer who have received satraplatin had slowing of the growth or shrinkage of their tumor. Researchers are interested in determining whether satraplatin can be effective for cancers that occur in children.
Objectives:
To evaluate the safety and effectiveness of satraplatin as a treatment for children and young adults who have solid tumors that have not responded to standard treatment.
To study the effects of satraplatin on the body in terms of side effects and blood chemistry.
To examine the effect that genetic variations may have on the effectiveness of satraplatin.
Eligibility:
- Children, adolescents, and young adults between 3 and 21 years of age who have solid tumors (including brain tumors) that have not responded to standard treatment.
Design:
Participants will be screened with a full physical examination and medical history, blood tests, and tumor imaging studies.
Participants will receive satraplatin pills to be taken every day in the morning for 5 consecutive days, with no food for 2 hours before or 1 hour after the dose. Participants will then have 23 days without the drug to complete a 28-day cycle of treatment. Participants will also receive medication to prevent nausea and vomiting 30 minutes before the first dose of satraplatin. Following the first dose of satraplatin, medication for nausea will be given if needed.
Satraplatin doses will be adjusted based on response to treatment, including potential side effects. Participants will have frequent blood tests and imaging studies to evaluate the effectiveness of the treatment and monitor any side effects, as well as hearing tests and other examinations as required by the study researchers.
Participants will receive satraplatin every 4 weeks for up to 2 years until serious side effects occur or the tumor stops responding to treatment.

Start Date03 Dec 2010

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Satraplatin

100 Translational Medicine associated with Satraplatin

100 Patents (Medical) associated with Satraplatin

193

Literatures (Medical) associated with Satraplatin

01 Dec 2024·Biochemical and Biophysical Research Communications

Quantum mechanical approaches and molecular docking studies of platinum based anticancer drugs Satraplatin and picoplatin structures

Article

Author: Sahadevan, Madhavi ; Subramanian, Karunagaran ; Sundaram, Mullainathan

The structures of the anticancer drug compounds satraplatin and picoplatin are optimized, and theoretical studies done by Density Functional Theory (DFT) to investigate the optical properties, global chemical descriptors, and band gap were calculated using the obtained Frontier molecular orbital values. The theoretically obtained data of the platinum drugs found to possess low energy gap values and low chemical hardness with high chemical softness describe that the compounds are chemically stable and most reactive. Using the molecular docking process, the binding mechanisms of the satraplatin and picoplatin drugs with cancer DNA structures were studied, and the results were analyzed. For the two drug compounds examined, satraplatin has shown the least binding energies at -5.06kcal/mol compared to picoplatin at -2.69 kcal/mol, and conformations with root mean square deviation (RMSD) values by DNA structures are less than or equal to 2.00 Å in targeting the specific DNA target residues of the reference bound ligand. The grid box was generated using the selective grid parameters using the Autodock 4.2 program. The drug molecules found to have the least binding energy value with the lowest inhibition constant implicate the good docking score towards the DNA structure by the docking studies. DFT studies also show good structural properties and chemical reactivity. From the obtained results, satraplatin and picoplatin were found to have good chemical descriptors and good binding affinity and are best suited for biological molecular targets.

22 Jul 2023·Journal of functional biomaterials

Nanoparticle-Mediated Delivery of Satraplatin to Overcome Cisplatin Drug Resistance.

Article

Author: Jiang, Xiaohan ; Yan, Lesan ; Yang, Qiang ; Qi, Ruogu

Drug resistance and cancer metastasis are the major obstacles for widely used platinum-based chemotherapy. It is acknowledgement that the decreasing intracellular accumulation of anticancer drugs and increasing sulfur-binding detoxification are two major mechanisms related to drug resistance. Herein, we developed a practical and straightforward method for formulating the clinically used anticancer drug satraplatin (JM-216) with D-α-tocopheryl polyethylene glycol succinate (TPGS)-based polymers to create satraplatin-loaded nanoparticles (SatPt-NPs). The experimental results demonstrate that SatPt-NPs exhibited comparable efficacy to A2780 in treating the A2780 cisplatin-resistant ovarian cancer cell line (A2780DDP), indicating their significant potential in overcoming drug resistance. Additionally, buthionine sulfoximine (BSO) is capable of depleting intracellular glutathione (GSH), resulting in reduced detoxification. After BSO treatment, the IC₅₀ value of SatPt-NPs changed from 0.178 to 0.133 μM, which remained relatively unchanged compared to cisplatin. This suggests that SatPt-NPs can overcome drug resistance by evading GSH detoxification. Therefore, SatPt-NPs have the ability to inhibit drug resistance in tumor cells and hold tremendous potential in cancer treatment.

06 Apr 2023·The Oncologist

Biomarker Development Trial of Satraplatin in Patients with Metastatic Castration-Resistant Prostate Cancer

Article

Author: Tsao, Che-Kai ; Gong, Yixuan ; Seng, Sonia ; Jun, Tomi ; Galsky, Matthew D ; Oh, William K ; Liaw, Bobby C

AbstractBackgroundIn the phase III SPARC trial, satraplatin, an oral platinum analogue, demonstrated anticancer activity in men with metastatic castration-resistant prostate cancer (mCRPC). Repeat biopsies are uncommon in mCRPC, limiting the feasibility of tissue–based biomarkers. This phase II study sought to evaluate the feasibility and utility of blood–based biomarkers to identify platinum–sensitive mCRPC.MethodsPatients with mCRPC who had progressed on docetaxel were enrolled at a single center from 2011 to 2013. Subjects received satraplatin 80 mg/m2 by mouth daily on days 1-5 and prednisone 5 mg PO twice daily, on a 35-day cycle. Serial peripheral blood samples were collected for biomarker assessment.ResultsThirteen docetaxel-refractory mCRPC patients were enrolled, with a median age of 69 years (range 54-77 years) and median PSA of 71.7 ng/mL (range 0.04-3057). Four of 13 patients (31%) responded to satraplatin (defined as a PSA decline of ≥30%). Responders demonstrated improved time to disease progression (206 vs. 35 days, HR 0.26, 95% CI, 0.02-0.24, P = .003). A 6-gene peripheral blood RNA signature and serum tissue inhibitor of metalloproteinase-1 (TIMP-1) levels were assessed as biomarkers, but neither was significantly associated with response to satraplatin.ConclusionIn this small series, one-third of mCRPC patients responded to platinum–based chemotherapy. Peripheral blood biomarker measurement is feasible in mCRPC, though the biomarkers we investigated were not associated with platinum response. Other biomarkers, such as DNA damage repair mutations, should be evaluated.

News (Medical) associated with Satraplatin

27 Feb 2006

·www.biospace.com

Pharmion Corporation Announces New Satraplatin Clinical Data From Pharmacokinetics Study At American Society of Clinical Oncology Prostate Cancer Symposium

BOULDER, Colo., Feb. 27 /PRNewswire-FirstCall/ -- Pharmion Corporation today announced the presentation of new clinical and preclinical data on satraplatin at the ASCO Prostate Cancer Symposium: A Multidisciplinary Approach in San Francisco, California. A poster entitled, "A Phase I Pharmacokinetic (PK)/Food Effect and Safety Study of Satraplatin," presented data from a study involving seventeen patients with advanced solid tumors. Most patients in the study were heavily pre-treated: the median number of prior chemotherapy treatments was three. Satraplatin appeared to be well tolerated, with no significant cardio, renal, liver or neurological toxicities observed. Other common toxicities like nausea, vomiting and diarrhea were mild to moderate and were reported to be controlled with prophylactic oral anti-emetic therapy. Seven patients in the study had hormone-refractory prostate cancer (HRPC), and all of the HRPC patients had received Taxotere (docetaxel), with a median of three prior chemotherapy regimens. Satraplatin showed evidence of anti-tumor activity in this group: one patient had a partial response (RECIST criteria), and two patients had prolonged stable disease (durations of 3.5 and five months). The study was designed to evaluate the effect of food on the bioavailability (i.e., the rate at which the drug is absorbed and the amount of drug absorbed) of satraplatin. Such data are useful in determining the best way for patients to take an oral drug. In this study, the peak plasma concentrations of satraplatin were decreased by approximately 20 percent following a high fat meal; however, the total amount of drug absorbed was not affected by food. The clinical implications of the reduced peak drug concentrations in the face of equivalent total amounts of drug absorbed in patients taking satraplatin following a high fat are not known. A second poster entitled, "Efficacy of Satraplatin, an Oral Platinum Analogue in Prostate Cancer: Synergistic Activity with Docetaxel," reviewed the preclinical results of studies evaluating the cell-killing effect of satraplatin and its metabolite on prostate cancer cells. In vivo and in vitro data showed that satraplatin and its active metabolite, JM-118, inhibited the growth of prostate cancer cells in a dose-dependent fashion. In addition, when satraplatin or JM-118 was combined in vitro with Taxotere, a synergistic effect was demonstrated in prostate cancer cells. This synergistic effect was strongest when Taxotere was followed by JM-118. About Satraplatin Satraplatin, an investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home. An oral platinum drug could offer key advantages, including ease of administration and patient convenience, in a variety of applications. To date, satraplatin is the only platinum compound that has demonstrated activity in a randomized trial in HRPC. Patient enrollment is completed for the Phase 3 registrational trial -- the SPARC trial -- which is assessing the safety and efficacy of satraplatin in combination with prednisone as a second-line chemotherapy in patients with HRPC. GPC Biotech has initiated the rolling submission of an NDA with the U.S. Food and Drug Administration (FDA) for satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with HRPC. Assuming continued progress, GPC Biotech expects to complete the NDA filing in the second half of 2006. Data from the SPARC trial are also expected to form the basis of an MAA in Europe for this indication, and Pharmion expects to submit that application in early 2007. Satraplatin has been studied in clinical trials involving a range of tumors, and Phase 2 trials have been completed in HRPC, ovarian cancer and small cell lung cancer. Other trials evaluated the effects of adding satraplatin to radiation therapy, a clinical application in which satraplatin's oral bioavailability could be particularly advantageous. A Phase 1/2 study evaluating this combination in patients with non-small cell lung cancer has been initiated. Several other Phase 1 and 2 studies evaluating satraplatin in combination with other therapies and in various cancers are underway or planned. Pharmion in-licensed satraplatin from GPC Biotech in 2005. About Pharmion: Pharmion is a pharmaceutical company focused on acquiring, developing and commercializing innovative products for the treatment of hematology and oncology patients in the U.S., Europe and additional international markets. Pharmion has a number of products on the market including the world's first approved epigenetic cancer drug, Vidaza(R), a DNA demethylating agent. For additional information about Pharmion, please visit the company's website at . Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Pharmion's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include the status and timing or regulatory approvals for Pharmion's product candidates; the impact of competition from other products under development by Pharmion's competitors; the regulatory environment and changes in the health policies and structure of various countries; acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of products newly launched, currently being sold or in development; Pharmion's ability to successfully acquire rights to, develop and commercialize additional pharmaceutical products; failure of third-party manufacturers to produce the product volumes required on a timely basis, fluctuations in currency exchange rates, and other factors that are discussed in Pharmion's filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made, and Pharmion undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise. Pharmion Corporation CONTACT: Breanna Burkart or Anna Sussman, Directors, Investor Relationsand Corporate Communications, Pharmion Corporation, +1-720-564-9150 Web site:

Radiation TherapyASCO

02 Nov 2005

·www.biospace.com

Spectrum Pharmaceuticals, Inc. Announces Start Of Phase 2 Trial With Satraplatin In Patients With Metastatic Breast Cancer

IRVINE, Calif., Nov. 2 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced that its co-development partner, GPC Biotech AG , has opened for accrual a Phase 2 study evaluating the Company's lead drug candidate, satraplatin, in patients with metastatic breast cancer who have received no more than one prior chemotherapy treatment regimen. The study is being managed by US Oncology. Satraplatin is currently in a Phase 3 registrational trial as a second-line chemotherapy treatment for patients with hormone- refractory prostate cancer. Spectrum's partner, GPC Biotech, is also opening new clinical studies to explore the potential of satraplatin in a number of additional tumor types. The Phase 2 study in metastatic breast cancer is an open label, multicenter study being managed by US Oncology, a leading healthcare services network dedicated exclusively to cancer treatment and research. Fifty-seven research sites in the US Oncology Network plan to participate in this trial. The primary objective of this study is to determine the objective response rate of satraplatin in this patient population. The study is expected to enroll 80 patients. "Our partnership with GPC Biotech enables us to advance the development of satraplatin, while also minimizing our expenses and preserving the upside associated with this promising drug for our company and our shareholders," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President. "While enrollment in the phase 3 trial in hormone refractory prostate cancer is on target for completion by the end of the year, the initiation of additional, exploratory studies evaluating satraplatin in additional indications is another step towards realizing the potential this drug might have on the treatment of cancer." "Despite advancements in treating breast cancer, it is important to continue to find and develop effective therapies, as patients with advanced disease often do not respond to existing treatments or will eventually relapse," said Joyce O'Shaughnessy, M.D., Co-Director of US Oncology's Breast Cancer Research Committee and Director, Breast Cancer Prevention at Baylor- Charles A. Sammons Cancer Center in Dallas, Texas. "Satraplatin, as an oral drug that is relatively well tolerated, could provide an additional option for these patients. I look forward to exploring the compound's potential in this disease setting." Breast cancer is the second leading cause of cancer-related death among women in the US and in Europe, behind lung cancer, according to the American Cancer Society. In 2005, it is estimated that over 210,000 new cases of invasive breast cancer will be diagnosed and over 40,000 women are expected to die from the disease in the U.S. The numbers are even higher in the European Union, with an estimated 270,000 new cases of the disease diagnosed annually and 88,000 deaths. While today in the U.S. the 5-year relative survival rate for localized breast cancer is 98%, the figure for patients with distant metastases is only 26%. About Satraplatin Satraplatin, an investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Worldwide sales of these drugs exceeded $2.2 billion in 2004. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home. An oral platinum drug could offer key advantages, including ease of administration and patient convenience, in a variety of applications. Satraplatin is in a Phase 3 registrational trial -- the SPARC trial -- as a second-line chemotherapy treatment for hormone-refractory prostate cancer (HRPC). Spectrum's partner, GPC Biotech, has completed a Special Protocol Assessment with the U.S. FDA and has received a Scientific Advice letter from the European regulatory authority, the European Medicines Agency (EMEA). The FDA has also granted fast track designation to satraplatin for this indication. Phase 2 trials have been completed in HRPC, ovarian cancer and small-cell lung cancer. Promising early clinical results have also been shown when satraplatin is combined with radiation therapy, and a Phase 1/2 study evaluating this combination in patients with non-small cell lung cancer has been initiated. A Phase 1 study evaluating satraplatin in combination with TAXOTERE(R) (docetaxel) in patients with advanced solid tumors is also underway. Additional studies evaluating satraplatin in combination with other therapies in various cancers are planned. Further information on satraplatin can be found in the Anticancer Programs section of the Company's Web site at . About US Oncology US Oncology, headquartered in Houston, Texas, is one of the nation's largest healthcare services networks dedicated exclusively to cancer treatment and research. US Oncology network practices are provided with unparalleled opportunities to participate in the ongoing clinical research and development of the newest promising cancer therapies. The network is currently involved in approximately 77 research trials that are open for enrollment and has contributed to the development of 23 of 29 of the latest cancer-fighting drugs approved by the FDA for use. Since initiation of the network, more than 29,000 patients have participated in clinical trials that have been managed by the US Oncology Network. US Oncology is affiliated with 985 physicians operating in 494 locations, including 97 radiation oncology facilities in 33 states. For more information, visit or contact Kimberly Rutherford at (832) 601-6193 or Kimberly.Rutherford@usoncology.com. About Spectrum Pharmaceuticals Spectrum Pharmaceuticals is a specialty pharmaceutical company engaged in the business of acquiring, developing and commercializing prescription drug products for the treatment of cancer and other unmet medical needs. By leveraging its operational flexibility and regulatory proficiency, and using the extensive research and development capabilities of its strategic alliance partners, Spectrum has built a diversified portfolio of proprietary and generic drug products in various stages of development and regulatory approval. For more information, please visit our website at . Forward-looking statements This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, the Company's operational flexibility and regulatory proficiency, the extensive research and development capabilities of the Company's strategic alliance partners, opening other new clinical studies to explore the potential of satraplatin in a number of additional tumor types, that satraplatin has demonstrated activity in a number of solid tumors, enrollment of 80 patients in the proposed trial, completion of enrollment in the phase III trial in hormone refractory prostate cancer by the end of the year, moving toward realizing the potential satraplatin might have on the treatment of cancer, that an oral platinum drug could offer key advantages, including ease of administration and patient convenience, in a variety of applications, the potential clinical results when satraplatin is combined with radiation therapy, the fact that satraplatin is relatively well tolerated and could provide an additional option for breast cancer patients, the compound's potential in treating the disease (breast cancer) and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that past results are not indicative of future results, the possibility that price and other competitive pressures may make the marketing and sale of our generic drugs not commercially feasible, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. Contact: Laurie Little Sr. Director, Investor Relations (949) 743-9216 Spectrum Pharmaceuticals, Inc. CONTACT: Laurie Little, Sr. Director, Investor Relations, SpectrumPharmaceuticals, Inc., +1-949-743-9216 Web site:

CollaborateGeneric DrugRadiation TherapyFast Track

100 Deals associated with Satraplatin

External Link

KEGG	Wiki	ATC	Drug Bank
D05807	Satraplatin	L01XA04	DB04996

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Castration-Resistant Prostatic Cancer	Phase 3	RU	Agennix AG	01 Sep 2003
Castration-Resistant Prostatic Cancer	Phase 3	PL	Agennix AG	01 Sep 2003
Castration-Resistant Prostatic Cancer	Phase 3	NL	Agennix AG	01 Sep 2003
Castration-Resistant Prostatic Cancer	Phase 3	RU	Agennix AG	01 Sep 2003
Castration-Resistant Prostatic Cancer	Phase 3	FR	Agennix AG	01 Sep 2003
Castration-Resistant Prostatic Cancer	Phase 3	AR	Agennix AG	01 Sep 2003
Castration-Resistant Prostatic Cancer	Phase 3	FR	Agennix AG	01 Sep 2003
Castration-Resistant Prostatic Cancer	Phase 3	PL	Agennix AG	01 Sep 2003
Castration-Resistant Prostatic Cancer	Phase 3	AR	Agennix AG	01 Sep 2003
Castration-Resistant Prostatic Cancer	Phase 3	NL	Agennix AG	01 Sep 2003

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00499694 (CTgov)	Not Applicable	Metastatic Prostate Carcinoma	31	bevacizumab+satraplatin	(hnxcdkeqcx) = mathjuryyj oofkpamobx (uzkwsmcyfw, acnlmhpwnq - yoophzgjen) View more	-	25 Aug 2014
NCT01289067 (ASCO_GU2014)	Phase 2	Castration-Resistant Prostatic Cancer	13	Satraplatin 80 mg/m2	(qtgtajbgtt) = bbdmkzkvta aifpbubuaj (gjpzozilwq ) View more	-	01 Feb 2014
NCT00634647 (CTgov)	Phase 2	Genetic Diseases, Inborn \| Metastatic Prostate Carcinoma	24	prednisone+Satraplatin	ztpijczfia(lsfesflbit) = cocqzrxsgx sqzookxleu (nwmyuivetm, mvygmulyqv - pndzjzvapz) View more	-	10 Apr 2013
ASCO2009	Phase 1	HR-positive/HER2-low Solid Tumors	15	Satraplatin	(qlcqvjsqlu) = otompejqcj hhupcdztml (ekibkyrwqq ) View more	-	20 May 2009
SPARC (ASCO2009)	Not Applicable	Metastatic castration-resistant prostate cancer Second line	488	Satraplatin + Prednisone	(tarjuunigt) = nhortcmktw icsgzlnfyj (xxupxsdwnx )	-	20 May 2009
SPARC (ASCO2009)	Not Applicable	Metastatic castration-resistant prostate cancer Second line	488	Placebo + Prednisone	(tarjuunigt) = tfrpnnuneb icsgzlnfyj (xxupxsdwnx )	-	20 May 2009
ASCO2008	Phase 1	Non-Small Cell Lung Cancer	-	Satraplatin	(wqmxbsmmyy) = lelqgjhirs xtmgwtijbj (wpszrvmvsw )	-	20 May 2008
ASCO2008	Phase 1	Advanced Malignant Solid Neoplasm	22	Satraplatin	(esnsxpkpgv) = yfacxohzdi vohdwoqxuf (fdpofrkpww )	-	20 May 2008
SPARC (ASCO2008)	Phase 3	Castration-Resistant Prostatic Cancer	950	Satraplatin + prednisone	(wotanjwdnd) = unranuenwr jkeiotdabm (wkypwvoapn )	Negative	20 May 2008
SPARC (ASCO2008)	Phase 3	Castration-Resistant Prostatic Cancer	950	Placebo + prednisone	(wotanjwdnd) = zjzqwydbfk jkeiotdabm (wkypwvoapn )	Negative	20 May 2008
ASCO2008	Phase 2	Non-Small Cell Lung Cancer First line	38	Satraplatin 80mg/m2	(bjvrrlqhsk) = xitrslnouv szrryahodh (qxhkztxmce, 9% - 39) View more	-	20 May 2008
ASCO2007	Phase 2	Advanced Lung Non-Small Cell Carcinoma First line	28	Satraplatin 80 mg/m2	(ktzgpjvpnx) = cjugusogfe qfbiteklij (vbbxmbqdbt, 5% - 37%) View more	-	20 Jun 2007

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